PHARMACEUTICAL & BIOTECHNOLOGY INDUSTRY
UPDATE
June 2011
McIlvaine Company
TABLE OF CONTENTS
Roche Sets up R&D Institute in France
ShangPharma Opens Pilot Plant in Shanghai
GW Plastics Opens New Facility in Costa Rica
Bruker Opens New Center of Excellence
Labtec Opens GMP Facility in Germany
Pan Continental CRO Neox Europe Launched
Lonza Announces Singapore Biomanufacturing Expansion
PRA Opens New Office in Sweden
Swiss Actelion is Planning Biotech Start-Up
AstraZeneca Eyes Russian Market
SSB and Sudpack Team on Plastic Films
NeoStem’s China Antibiotics Unit Gets SFDA Approval
Novartis Begins Construction in St. Petersburg, Russia
Glycotope Biotechnology Antibody Production Facility, Germany
GSK Investing in Ontario Plant
Roquette Completes Injectable Plant
SGS Wavre Site Gets WHO Prequalification
West Breaks Ground on China Mfg. Plant
GSK Breaks Ground in Philadelphia
Dr. Reddy’s Chemical Manufacturing Facility at Cuernavaca, Mexico
SSB and Sudpack Team on Plastic Films
Celerion Labs OKed by Brazilian Regulators
GVK Biosciences Teams with Indiana CTSI on Biomarker Resource
Impax Unveils Taiwan Expansion Plan
DSM Joint Venture Agreement in China
SAFC and Pfenex Partner on Protein Production
Chengdu Wagott to Double Stevia Capacity
DSM Plans Joint Venture Agreement in China
BeamOne Increases Presence in Costa Rica
R-Pharm Buys Xcellerex FlexFactory Line
GW Plastics to Enter Costa Rica
Quintiles Egyptian JV Operational
Labtec Opens Facility in Hamburg, Germany
Quotient Expands Its Clinical Facilities
SGS Plans Facility in Mumbai, India
LabCorp to Acquire Clearstone Central Laboratories
Clearstone Expands Toronto Site but Is Closing NJ Lab
Clearstone Expands Through Mitsubishi Partnership
Bilfinger Berger Works on Genzyme Plant
GE Opens Technology Facility in Sweden
SAFC Manufacturing Fermentation Facility, Israel
SCHOTT Pharmaceutical Systems Expands its Worldwide Network
Lonza Singapore Biomanufacturing Expansion
Lonza Expands in Slough, England
Helsinn to Build Cytotoxic Plant in Switzerland
MTC to Build Cleanroom for Wasdell Packaging
Ameridose Opens Sterile Admixing Facility
Syngenta Selects North Carolina for Expansion.
Symetic Opens Process Tech Demo Lab
BioScale Opens New Lexington HQ
University of Hawaii Medical School Investment
Fujifilm Diosynth Biotechnologies Adds Single-Use Bioreactor
Multiple Benefits from Single Use Project
Harvard's New Science Facilities
Abcam PLC Buys and Expands MitoSciences
HWI Global Commences Construction of Clean Room for Powerex
Walter Reed Army Institute of Research to Install Cleanroom
Nypro Investing in North Carolina and Massachusetts
Spanish Vaccine Maker Plans Iowa Plant
Pfizer Investing in Research Partnership
CMO Senn Chemicals has Office in California
Ximedical Opens Branch in Minnesota
Life Science Company Relocating California Headquarters to Indiana
Goodwin Biotechnology and Rafagen Team on Manufacturing
Jackson Lab Abandons Plans for Florida Expansion
University of Florida Breaks Ground on Research Building
Investment in Maryland from Chinese Biopharma Tasly
DaVita Clinical Research Opens Cleanroom
UF breaks Ground for Clinical and Translational Research Building
Triclinic Expands Chemistry Services Lab
NYU to Open New Genomics Center
Roche announced the launch of a new R&D Institute in France under the lead of the company’s Pharma Research and Early Development (pRED) unit. The pRED French R&D Institute will be fully dedicated to collaborative translational research and medicine, with the objective to build in-depth strategic partnerships with leading French academic centers in areas of mutual interest.
The Institute will serve as the single entry-point for academic collaborations in France across multiple disease areas and scientific disciplines: oncology, neurosciences, metabolism, inflammation, virology, translational research and toxicology.
“We are committed to establishing robust collaborations in France, which ranks among the leading nations in life-science research, with internationally recognized experts and a fantastic innovation potential,” comments Jean-Jacques Garaud, Global Head of pRED at Roche." The pRED French R&D Institute will enable us to work hand-in-hand with France’s world-class scientists in a common objective: accelerating the translation of early scientific discoveries into innovative and personalized treatments for patients.”
With the French R&D Institute, Roche adds another piece to its network of external “hubs”, joining academic collaborations established in Singapore, Switzerland with Basel and Geneva, and the Netherlands. Those multidisciplinary collaborative models with multiple investigators and universities aim at more rapidly advancing biomedical research from the lab to the patient.
The pRED French R&D Institute will be managed by a dedicated Roche academic alliances group. This multidisciplinary team will be in charge of building new research networks with leading French academic partners, leveraging their expertise, novel technology platforms and scientific breakthroughs in areas of high unmet medical need.
“Our objective is to accelerate the development of new therapeutic solutions that will benefit to public health – and above all, to the patients,” explains Roche Pharma France CEO Sophie Kornowski-Bonnet. “Through this network of strategic collaborations with best-in-class French academic centers, we, at Roche, intend to leverage the fantastic innovation potential of France and progress towards our mission to deepen our understanding of life sciences.”
ShangPharma Corporation, a China-based contract research and manufacturing organization, has started operations at a new manufacturing facility in the Shanghai suburb of Fengxian.
The new multi-purpose pharmaceutical development and cGMP manufacturing facility will allow ShangPharma to support its clients Phase II and Phase III trials, expanding its service offering to include process and formulation R&D, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.
Previously the CRO/CMO provided clients with materials for early discovery and GLP toxicology testing and Phase I clinical trials.
ShangPharma said it might further expand its manufacturing facilities if there is demand for commercial manufacturing of FDA- or EMEA-approved drugs.
The Fengxian facility will operate as a wholly owned subsidiary of the company under the name China Gateway Pharmaceutical Development Co. It includes a pilot plant that supports six separate bays with reactor capacities ranging from 200 to 3,000 liters and other specialty bays with reactor capacities ranging from 50 to 2000 liters for high temperature, cryogenics, highly toxic and pressurized reactions, including hydrogenation.
The company said there are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-lab suites for bothnon-cGMP and cGMP manufacturing, as well as a large R&D laboratory for analytical, formulation and process development activities.
In addition, there are separate buildings for utilities, materials management, warehouse storage and waste water treatment with room for further expansion to support commercial manufacturing activities.
Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department will ensure that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed, the firm said.
Fill/finish specialist SCM Pharma has launched two testing services to complement its sterile manufacturing capabilities.
The UK-based contract manufacturing organization (CMO) has added Sterility and Bacterial Endotoxin Testing (BET) to its GMP-compliant facility, which will supplement its analytical, stability and microbiological testing capabilities.
Dianne Sharp, managing director at SCM Pharma, said: ‘The launch of these in-house testing services is a major milestone in the firm’s development in that it allows us to fill, test and release sterilized product for our clients all under one roof.’
She added: ‘Not only will this reduce the potential risk of loss, breakage, documentation issues and delays associated with offsite testing but by allocating testing slots straight after sterile filling, our clients are also likely to get their product quicker.’
The sterility testing is performed within a validated grade A environment using a sterility test isolator located in a cleanroom. Using an isolator as opposed to other conventional methods will help reduce the potential for costly delays and lengthy investigations, the company said.
BET is carried out in a designated area of the microbiology laboratory using the Quantitative Turbidimetric Assay technique. Aimed at reducing lead times and minimizing risk for client projects, BET is performed using GMP compliant computer software allowing quick generation of COAs and results.
The new testing services are a logical addition to SCM’s Pharma’s aseptic processing and terminal sterilization capabilities, allowing the company to fill ampoules, vials and syringes.
SCM Pharma specializes in the fill/finish of novel, difficult and dangerous drug products. It has expertise in the filling of highly potent products, radio-labeled compounds and non-live biologicals.
GW Plastics Corporation has opened a new medical manufacturing facility in Cartago, Costa Rica. The new facility marks the establishment of GW Plastics Catargo, a joint venture with Catargo-headquartered Corprosemm Corporation. The facility is located in the Cartago-Techno Park Free Trade Zone, about 16 miles southeast of San Jose.
“We are delighted to form a partnership with Corprosemm and are committed to meeting the global outsourcing needs of our healthcare customers,” said Brenan Riehl, GW Plastics president and CEO. “A manufacturing location in Costa Rica will allow us to more effectively support our customers in Latin America.”
Production will begin this summer at the 10,000-square-foot injection molding and ISO Class 8 cleanroom assembly facility owned by Corprosemm Corporation. Early next year, production will expand to the new 33,000-square-foot facility that currently is under construction—the new space will be capable of expanding to 44,000 square feet, depending on business needs.
“Our experience acquired during many years in the healthcare industry will support GW Plastics’ decision to enhance its global presence with this manufacturing operation. We are absolutely confident in the success of this business partnership,” said Magin Mora, one of the founders of Corprosemm.
GW Plastics’ corporate headquarters is in Bethel, VT.
Bruker, a leading provider of high-performance scientific instruments for molecular and materials research, as well as for industrial, clinical and applied analysis, celebrated the grand opening of its new Singapore Center of Excellence.
Located at the Helios in Biopolis, Singapore’s biomedical research and development hub, Bruker Singapore provides sales and after-sales services for South East Asia, including a regional applications and customer training center equipped with the latest Bruker systems. Bruker Singapore also provides business and financial services for Bruker operations in the region, and Bruker Singapore is expected to become a significant life-science and applied markets research center.
Dr. Frank Laukien, Bruker’s President and CEO, commented: “With this major investment in our new Center of Excellence, Bruker Singapore has taken a major step forward to provide highest-level support and collaboration capabilities for our research, biopharma, clinical and advanced materials and industrial customers in South East Asia. We have taken a keen interest in Singapore’s progress on the biomedical and life sciences front. The proactive, long-term stance taken by the government and its agencies, such as EDB and A*Star, to support industry by anchoring scientific research activities here is an impressive model. I am very pleased that Bruker can be a part of this exciting development.”
Bruker’s analytical and research systems are well recognized for their innovation, highest performance and quality. The company’s magnetic resonance (NMR, preclinical MRI and EPR) products are market-leading across all of Asia, and can also be found in A*Star’s research centers, universities and pharmaceutical companies in Singapore. Bruker also offers a wide range of performance-leading life-science and materials research solutions, including systems for atomic force microscopy (AFM), stylus and optical metrology, X-ray diffraction and crystallography, X-ray and spark-OES elemental analysis, life-science and applied markets separations and mass spectrometry, as well as infrared and Raman spectroscopy.
Dr. Beh Swan Gin, Managing Director of the Singapore Economic Development Board (EDB) remarked: “I would like to congratulate Bruker Singapore on the opening of its new office that will better serve the Asian markets through customer training and applications support. Leading companies like Bruker that provide scientific equipment to support researchers, play an important role in the advancement of science and technology. We look forward to a continued partnership between Bruker and Singapore as the company grows its presence here.”
The new center in Singapore includes a custom built multi-technology laboratory configured to suit the wide range of technology solutions. Currently, Bruker Singapore has about 45 staff and expects to hire 10 - 20 more staff at the graduate to Ph.D. level as its business expands.
Mr. George Tang, General Manager of Bruker Singapore, said: “Our operations in Singapore have grown ten-fold since we first established a presence in 1998. The new Center of Excellence in Singapore reflects our larger role in serving Singapore and South East Asia. As Singapore grows as a Science and Biomedical research hub, we want to facilitate its development by providing our equipment and expertise to our customer-partners through our presence here. We have recently entered the field of microbiology here in Singapore and are excited to see the latest proteomic microbial identification technology now supporting better clinical decisions in infectious disease management. Bruker is also increasingly outsourcing some of its production to Singapore and South East Asia, and we are of course a major technical tool provider and partner for Singapore’s and the region’s world-class semiconductor, data storage, solar and LED manufacturers.”
Labtec GmbH, a subsidiary of tesa SE, has opened a new GMP manufacturing plant for transdermal drug delivery systems (TDS) and oral dispersible films (ODF) employing its RapidFilm technology.
The facility is located within tesa’s largest manufacturing site, tesa Werk Hamburg GmbH, south of Hamburg, Germany. The production facility provides for industrial mass production and includes coating and drying lines with variable coating widths. The facility has modern slitting machinery and high-precision, flexible converting and packaging equipment dedicated to TDS and ODF. The plant operates with a cleanroom environment and is GMP compliant.
Ingo Lehrke, managing director at Labtec said, “It took only one and a half years from the initial planning phase until completion of construction and start of operation of the unit. This quick implementation is the result of an extremely close and dedicated cooperation between experts from tesa, Beiersdorf and Labtec. We are now able to combine Labtec’s pharmaceutical know-how with tesa’s extensive manufacturing expertise to supply our customers with innovative drug delivery products.”
A new firm joined the contract research sector with the launch of Neox Europe, an organization combining a number of CROs operating across the continent that has global ambitions.
The new company is made up of Prague-based contract research organization Neox Czech, a provider of Phase II to IV services, joins sister organization Neox Poland, Hungary’s BiTrial, Croatia-headquartered Sermon and Austrian firm MM Consulting.
Neox Europe said that the decision to merge the five companies is a ‘logical result’ of the close working relationship they developed following collaboration on a number of contract clinical trial projects.
The firm also has close ties with other European research organizations, namely Finland’s Secret Files Oy, Axonal in Belgium and France and Italian observational study specialist MediData srl. This gives the organization a 350-strong team with operations in 18 countries.
In a press statement Pavel Marek, CEO of the Neox Czech explained that the decision to go beyond the partnership model and carry out a formal merger reflects the evolving needs of the pharmaceutical sector.
“Global projects are more and more challenging, requiring well educated and trained staff. This approach is vital in order to meet the increasing requests and needs of pharmaceutical companies. That is why we created united company to become one team."
"We don´t want to run studies in USA, it is not where our expertise is. Our intention is to show US- based clients, that we are experts in Europe, and that it is possible to perform clinical trials in Europe very cost-effectively while still maintaining high quality standards, said medical director Petr Potuznik.
The launch of Neox Europe follows just weeks after Aptiv Solutions, a CRO combining Averion International, Trio Clinical Research, ClinResearch, Niphix, Addplan and Fulcrum Pharma, officially joined the US trial sector.
Both deals are further evidence that the wave of consolidation sweeping the research services sector is not restricted to larger players like inVentiv, INC and Clinpace.
The formation of Neox and Aptiv is also unlikely to have escaped the attention of private equity firms interested in keeping up with peers like Nautic Partners and CCMP Capital, which have both acquired CROs in recent years.
Grindeks has opened a 2,300 sq. meters (24,748 sq. ft.) API production plant in Latvia, that will boost UDCA sales to €10m ($14m) a year when at full capacity.
Construction of the €8.94m active pharmaceutical ingredient (API) facility in Riga, Latvia began in 2009 following collaboration between Grindeks and Germany-based Marenis Pharma. The plant is now completed and will begin boosting API business at Grindeks and adding to Latvia's growing export portfolio.
“Now, when Latvia has exceeded pre-crisis export volumes, it is very important to be able to find new products and niches, new markets and directions for further export growth”, said Valdis Dombrovskis, Prime Minister of the Republic of Latvia. The European Union gave Grindeks €3.9m towards construction of the plant.
Adding production capacity for ursodeoxycholic acid (UDCA), an API used in the treatment of primary biliary cirrhosis, furthers Latvia's exports ambitions. Grindeks says demand for UDCA is growing, with 400t a year now produced, and by 2014 it aims to have captured 15 per cent of the market.
For now Grindeks has hired 35 people to work at the plant, which uses an automatic management system to regulate production processes, control the microclimate and support the work of engineering systems.
By 2014 Grindeks plans to have moved into UDCA-based finished dosage forms. A two to three year plan has been created for the development and registration of the final dosage form. Entering the finished dosage forms market could add a further €10m in sales, claims Grindeks.
Vertical integration of manufacturing, bringing together API and finished dosage capabilities, is a strategic priority at Grindeks. Finished dosage forms account for the bulk of sales at Grindeks and generated revenues of €81.4m in fiscal 2010, up almost 20 per cent year-on-year. Russia and Georgia are key markets for Grindeks.
Switzerland-based life sciences supplier Lonza says it will invest CHF10m (€8m) to expand a Singapore plant that is part of its custom biomanufacturing business.
The investment, which is due to be completed in 2012, will add nearly 2,000 sq. meters (21,520 sq. ft.) of laboratory space at the facility in the Tuas Biomedical Park to support Lonza’s contract cell line development, processing and analytical services businesses.
Janet White, head of development Services, Lonza, said that: “Increasing demand in Asia drives us to Singapore where we have a strong relationship with the government and are already in the process of building a biomanufacturing hub."
White added that: “For Lonza, offering manufacturing and development services from one plant makes sense," and going on to say that the firm will hire employees locally in line with customer demand
Lonza has not said if the decision to expand the Singapore site will have any impact on the facility in Slough, UK that is the current base for its custom biomanufacturing unit.
News of the Lonza's expansion plan follows just weeks after Singapore’s Ministry of Trade and Industry (MTI) raised its estimates for the country’s economic growth to between 5 and 7 per cent, citing the biomedical sector as a driver.
PRA International has opened a new office in Lund, Sweden, citing increasing demand for clinical research in Scandinavia.
The office, in the Southern city Lund, is intended to be a regional base of operations for the contract research organization’s (CRO) research associates and start‐up teams for Phase II to IV clinical trials and will work in concert with its units in Denmark, Finland and Norway.
Lund is located in Oresund, a hub for life science businesses situated in Sweden’s Medicon Valley, which is widely acknowledged as one of Europe's primary centers for biotech and pharmaceutical activity. The area is also home to several top universities.
PRA, which has operated in Sweden since 2005, said that investment in the new office is a reflection of growing pharmaceutical industry demand for clinical research in the country.
And, while this is the usual justification given anytime a CRO opens a new office anywhere, in this instance the claim fits with market analysis.
According to a recent report by Invest Sweden, in the past five years Sweden has participated in 11 per cent of all trials initiated in the European Union, which a far higher share than its population would indicate given that the country is home to roughly 2 per cent of the continent’s population.
Sweden is also the world’s twelfth largest producer of clinical research results and second biggest per capita producer of medical research publications, according to analysis conducted in 2009 by the Academy of Finland and Swedish Research Council.
In a press statement Ludger Langer, PRA's Vice President of Clinical Operations in Europe, Asia-Pacific and Africa said: "Providing our local teams with a centralized location for operations strengthens our client offerings in this region."
The Lund site is one of a string of openings PRA has undertaken in Europe in recent months, which began in December with facilities in Poland and the Czech Republic and continued more recently with an office in Ukraine in February.
It will be led by current chief medical officer Isaac Kobrin, who has been tasked with planning and then ultimately heading up the new venture.
Kobrin’s new role was announced as part of a wider management reshuffle, which includes a focus for chief executive Jean-Paul Clozel on more “strategic maters” and the appointment of Otto Schwarz as chief operating officer.
AstraZeneca has announced plans to set up a hi-tech "predictive science centre" in St. Petersburg as part of a major bid to establish a strong presence in the Russian pharmaceutical industry.
According to the company, the new facility will leverage local scientific talent and focus on developing bioinformatics, data analysis methods, software and systems.
The deal comes shortly after the company began construction of a new $150m manufacturing facility in the Kaluga region, as well as the signing of new partnerships with Russian pharma developers Skolkovo Innovation Centre and Russia Venture Company.
Sartorius Stedim Biotech (SSB) has teamed up with packaging firm Sudpack Medica AG in a deal focused on making plastic films for biopharmaceutical industry applications.
Under the deal, financial terms of which were not disclosed, Sudpack will make plastic film materials for the production of SSB’s line of single-use cell cultivation bags and systems.
The firms will also collaborate on the development of novel film technologies for application in bioreactors, the first of which is expected to reach the market this time next year.
The partnership is a good fit according to Oscar-Werner Reif, EVP of R&D at France-headquartered Sartorius, who explained that: “We have gained an excellent partner for the development and manufacture of complex multi-layer films that we process in the production of our single-use bags.
“By supplying innovative single-use products, we are striving to continue offering our customers real added value in the future as well.
Johannes Remmele, Managing Director of Sudpack, agreed, suggesting the partnership is an important step into new markets for his company.
“We are proud that Sartorius Stedim Biotech, one of the market leaders in the biotechnology industry, has selected us as a partner to jointly develop innovative film laminates.
“This also tells me that we are on the right track with our strategy of continuously investing in new technologies and developments.”
Single-use bioreactors are an increasingly important part of Sartorius business, which last month launched UniVessel SU, a single-use, stirred tank reactor that has a two liter working volume.
At the time Andre Grebe, company head of product management multi-use bioreactors, said that “Demand is very healthy, mainly for process development in the biopharmaceutical space.”
He explained that fully-disposable systems like UniVessel meet industry demands for technologies that allow the maximum number of experiments to be conducted at the lowest operational and maintenance cost.
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
Erye has received approval from the Chinese State Food and Drug Administration (SFDA) for its sixth major production line at a facility Suzhou’s Xiangcheng district, which is responsible for the production of over 20 finished drugs.
The line is one of eight due to be installed at a facility to which Eyre has been transferring operations since 2010. Currently various types of penicillin and cephalosporins are made at the site.
NeoStem CEO Robin Smith said the approval will help alleviate capacity constrains that Eyre started face at the facility, and explained that this and China’s market potential were the key motivations for the investment
“The Chinese pharmaceutical market, which is the third largest in the world, has estimated sales of over $50 billion for 2011, and is expected to double in the next five years.
“This significant forecasted growth was an important consideration in our agreeing to reinvest our dividends into the company to support the relocation so that Erye can be positioned to capture this growth and maximize the value of NeoStem’s 51 per cent interest in Erye.
Dr. Smith also predicted that based on the new capacity and anticipated volume growth “Erye’s top line revenues should see solid growth in the years ahead and NeoStem’s management will consider our multiple options to realize the benefits of this increasingly valuable asset."
The antibiotics market in China was worth approximately $8.8bn in 2007, with an annual average growth rate of approximately 24 per cent for the previous three years. The overall pharmaceuticals market in China is forecasted to triple in size by 2013, to become the third largest drug market in the world, behind the US and Japan.
Novartis held a groundbreaking ceremony to announce the start of construction of a pharmaceutical manufacturing plant in St. Petersburg, Russia.
The construction of this facility represents the most significant Novartis investment in Russia to date. This facility will further expand the company's capabilities to produce and deliver both innovative pharmaceuticals and high-quality generics to Russian patients.
The new greenfield facility will be built in the Novoorlovskaya Special Economic Zone (SEZ), located to the north of the St. Petersburg city center. Once completed and approved for commercial production, which is expected in 2014, the state of-the-art facility will use cutting-edge technologies to produce approximately 1.5 billion units per year. It will also be an attractive workplace for local talent, employing more than 350 highly qualified professionals who will have access to world-class training and development programs at Novartis.
'The establishment of the new Novartis manufacturing facility demonstrates our commitment to invest in the Russian healthcare infrastructure and to contribute to the long-term goals of improving healthcare in Russia, set by the government', said Joseph Jimenez, CEO, Novartis AG. 'The plant in St. Petersburg is the latest step in our strategy to bring both innovative pharmaceuticals and low cost, high quality generics closer to patients and customers in Russia.'
This facility is part of a USD 500 million five-year investment into Russian healthcare infrastructure announced by Novartis in December 2010. This comprehensive partnership addresses three core areas which are local manufacturing, R&D collaborations and public health development in Russia.
Novartis and its predecessors have been active in Russia since the 1860s, and the company is one of the key players in the Russian pharmaceuticals market. Novartis currently employs over 2,000 professionals in Russia across all business divisions, spanning Pharmaceuticals, Alcon, Sandoz, Consumer Health and Vaccines & Diagnostics.
Glycotope Biotechnology, a wholly owned subsidiary of Glycotope GmbH, operates an antibody production facility in Heidelberg, Germany. The facility is located within the 6,000m2 (64,560 sq. ft.) Czernyring site of the Heidelberg Technology Park, the second largest site of the park.
The facility is close to several life science centers including the University of Heidelberg's institute for life sciences, the German Cancer Research Centre (DKFZ), the Max-Planck-Institute (MPI) for Medical Research, the Center for Molecular Biology of Heidelberg (ZMBH) and the European Molecular Biology Laboratory (EMBL).
The facility was acquired from Orpegan Pharma in July 2008. Since 2001, the facility has been ISO 9001:2000 certified and inspected by the state authorities. It is additionally approved by the German Gene Technology law (GenTG), the German Protection against Radiation ordinance (StrlSchV) and the corresponding German law for Control of Epidemics (IfSG, BioStoffV).
An expansion to the facility is underway to increase the plant's capacity. The ongoing expansion marks phase 1 and will increase the plant's recombinant production capacity to 4kg by mid 2011. During the remaining phases, the plant's capacity will be further increased to 11kg by the end of 2011. The expansion is expected to leverage the company's position as a leading provider of recombinant proteins and antibodies in Germany.
The facility is spread over 3,500m² (37,660 sq. ft.). Approximately 1,500m² (16,140 sq. ft.) of the facility has been dedicated for biotechnology production. The facility houses 300m² (3,228 sq. ft.) of research and development laboratories, 200m² (2,152 sq. ft.) of quality control laboratories, 700m² (7,532 sq. ft.) of warehouses and 200m² (2,152 sq. ft.) of offices.
The biotechnology production area accommodates four independent class D GMP-production suites for fermentation of mammalian cell-lines in fed-batch and perfusion mode. The suites are installed with a number of mammalian cell stirred tank fermentors ranging in capacities from 10l, 100l to two 300l.
Cell retention units have been installed to conduct fermentation in perfusion mode. Cultivation in perfusion mode can be performed up to 7,500l batch size. The clean suites include ISO class 8 hygienic zones that are monitored at regular intervals. The purification suites are classified to ISO 7.
As part of the expansion, new clean rooms are being added to the biotechnology production area. The expansion will add a total of 1,400m² (15,064 sq. ft.) of manufacturing, downstream processing and office space to the facility.
The facility develops therapeutic proteins including antibodies, second generation antibodies and glycoprotein-based biotherapeutics primarily for cancer therapy.
The products, including three that are currently in various stages of clinical development, are manufactured based on the company's patented GlycoExpress (GEX) technology. The facility also offers semi-automated sterile filling of aseptic solutions. Filling capacity ranges up to 500 vials per batch.
The facility adopts Glyco-Express technology besides producing recombinant proteins using the cell lines of the customers. Using the Glyco-Express technology, the company's patented serum free glycol-engineered human cell lines are optimized to result in a positive glycosylation pattern.
"The facility was acquired from Orpegan Pharma in July 2008."
The recombinant proteins are produced in cell cultures using several methods including batch, fed batch, repeated batch and perfusion. The complex carbohydrate (sugar) structures are bound to a protein by the cell lines. The manner in which the sugar structures are composed influence the biologic and clinical characteristics of the proteins and vaccines substantially including its activity, serum half-life time and the immunogenic side effects.
During downstream processing, the biopharmaceuticals are recovered and purified. The structural and functional characteristics of the recombinant protein are retained following the removal of all impurities.
The protein is collected from harvest using the appropriate chromatography methods including Ion Exchange Chromatography (IEC), Size-exclusion chromatography (SEC), hydrophobic interaction chromatography (HIC), Reversed-phase chromatography (RP) and Affinity chromatography. The APIs finally filled in clean suites with level "A in B" standard.
GlaxoSmithKline (GSK) is investing more than CA$30m (€21m) to add dermatology product manufacturing capabilities and create 70 jobs at a Canadian plant.
Expansion of the Mississauga, Ontario plant protects the jobs of 300 people, adds another 70 positions and extends production capabilities at the facility. In particular, the addition of manufacturing capabilities for dermatology products moves the plant into a whole new area of GSK's business.
“This investment supports our place in the global network as a supplier of foams, ointments, lotions, liquids and other niche products. It is the direct result of the strength of our Canadian manufacturing”, said Sue West, vice president, global manufacturing and supply at GSK.
Expansion of the plant will also add capacity for producing Coreg CR (carvedilol tablets) and Relenza (zanamivir dry powder inhalation). GSK has committed more than CA$30m to the project and the state of Ontario is providing a further CA$3.6m.
Providing support to attract investment is a central component of Ontario's job creation and retention strategy. In its 2011 budget, released in March, Ontario said it will make strategic investments in private sector partnerships to retain nearly 10,000 jobs.
“This major investment from GSK is a perfect example of innovation investment. It provides a highly effective way of progressing and commercializing cutting-edge research”, said Russel Williams, president of Canadian pharmaceutical association Rx&D.
Investment in the Ontario site follows the creation of a development fund by GSK and Canadian group MaRS Innovation. The partnership, called the GSK-MaRS Innovation Fund, will support commercialization of products created by 16 Canadian research institutions.
In other news GSK has broken ground on its 205,000 sq. ft., four-storey building in Philadelphia, Pennsylvania. The site is due to be completed around the start of 2013, after which GSK employees based at One and Three Franklin Plaza buildings will relocate to the new location at the Navy Yard.
“Designed to increase collaboration and communication, the new space will inspire our employees to and help them find the innovative solutions that will improve the health of the patients we serve”, said Deirdre Connelly, president of North America pharmaceuticals at GSK.
Roquette has completed its new injectable carbohydrate plant at its Lestrem facility. The new plant will support the increasing demands of the injectable industry in terms of quality. The facility complies with GMP standards and the integration into current production capacity will be seamless though 2011.
Roquette has pioneered the development of dextrose grades for the preparation of injectable and dialysis solutions and is a leader in the manufacturing of such carbohydrates in Europe. Roquette has also invested in an identical facility in the U.S. for international supply backup options.
SGS Life Science Services' site in Wavre, Belgium, has received prequalified status from the World Health Organization (WHO). This status demonstrates that a lab has met established global quality guidelines for Good Practices for National Pharmaceutical Control Laboratories and Good Manufacturing Practices (GMP) and lists the site as eligible to test and release medicines for WHO.
SGS's site in Chennai India received prequalified status in January 2011. "The members of WHO's prequalified laboratories is limited to a list of 20 facilities," said Anne Hays, executive vice president for SGS Life Science Services. "SGS is proud to have the distinction of being the only organization with two prequalified laboratories on the list."
The site has been in operation since 1971 and is located in the suburbs of Brussels. It has passed inspections by FDA and EMA and operates under GLP, GCP and cGMP.
West Pharmaceutical Services hosted a groundbreaking ceremony to mark the start of construction for a compression molding plant in the Shanghai Qingpu Industrial Zone (SQIZ) in China. The new plant will be adjacent to West’s injection molding facility, which was dedicated in September 2009.
The 11,900-sq.-m. (128,044 sq. ft.) plant will manufacture components used for pharmaceutical packaging, supplying customers primarily in China and the Asia-Pacific region. It is slated to begin production in January 2013.
“West is experiencing an exciting period of growth in the Asia-Pacific region and we are proud to begin our second manufacturing facility in China,” said Donald E. Morel, Jr., West’s chairman and chief executive officer. “This facility is being established to provide better service to our customers in China, offering shorter lead times for delivery of our world-class pharmaceutical packaging products and creating new, flexible capacity to meet the growing needs of new customers in China and throughout the Asia-Pacific region. Our investment in this new facility demonstrates our commitment to and confidence in the China market."
In addition to the injection molding plant in Qingpu, West's presence in the Asia-Pacific region includes a factory in Singapore and sales offices in Australia, China, India and Singapore. West is also an equity partner of Daikyo Seiko, Ltd., Tokyo, Japan. Daikyo Seiko, founded in 1954, is a global leader in manufacturing ultra-clean pharmaceutical packaging and medical device components. The West/Daikyo relationship has been in place since 1973, encompassing a range of joint distributorship and technology licensing agreements.
In other news GSK has broken ground on its 205,000 sq ft, four-storey building in Philadelphia, Pennsylvania. The site is due to be completed around the start of 2013, after which GSK employees based at One and Three Franklin Plaza buildings will relocate to the new location at the Navy Yard.
“Designed to increase collaboration and communication, the new space will inspire our employees to and help them find the innovative solutions that will improve the health of the patients we serve”, said Deirdre Connelly, president of North America pharmaceuticals at GSK.
Dr. Reddy’s Laboratories Ltd. announced that Industrias Quimicas Falcon de Mexico SA de C.V. (Dr. Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned subsidiary of Dr. Reddy’s Laboratories Limited, has received a four item Warning Letter from the United States Food and Drug Administration (USFDA).
The USFDA inspected Dr. Reddy’s Mexico facility in November 2010. That Inspection resulted in issuance of Form FDA 483, with observations. Dr. Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the USFDA has asked for additional data and corrective actions to the items listed in the Warning Letter. Dr. Reddy’s takes these matters seriously and will respond to the USFDA within the stipulated timeframe. Dr. Reddy’s looks forward to working collaboratively with the USFDA to resolve the matters
contained in the Warning Letter.
The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients.
Dr. Reddy’s Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - , and Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand.
Sartorius Stedim Biotech (SSB) has teamed up with packaging firm Sudpack Medica AG in a deal focused on making plastic films for biopharmaceutical industry applications.
Under the deal, financial terms of which were not disclosed, Sudpack will make plastic film materials for the production of SSB’s line of single-use cell cultivation bags and systems.
The firms will also collaborate on the development of novel film technologies for application in bioreactors, the first of which is expected to reach the market this time next year.
The partnership is a good fit according to Oscar-Werner Reif, EVP of R&D at France-headquartered Sartorius, who explained that: “We have gained an excellent partner for the development and manufacture of complex multi-layer films that we process in the production of our single-use bags.
“By supplying innovative single-use products, we are striving to continue offering our customers real added value in the future as well.
Johannes Remmele, Managing Director of Sudpack, agreed, suggesting the partnership is an important step into new markets for his company.
“We are proud that Sartorius Stedim Biotech, one of the market leaders in the biotechnology industry, has selected us as a partner to jointly develop innovative film laminates.
“This also tells me that we are on the right track with our strategy of continuously investing in new technologies and developments.”
Single-use bioreactors are an increasingly important part of Sartorius business, which last month launched UniVessel SU, a single-use, stirred tank reactor that has a two liter working volume.
At the time Andre Grebe, company head of product management multi-use bioreactors, said that “Demand is very healthy, mainly for process development in the biopharmaceutical space.”
He explained that fully-disposable systems like UniVessel meet industry demands for technologies that allow the maximum number of experiments to be conducted at the lowest operational and maintenance cost.
U.S. early-stage focused CRO Celerion has received Brazilian regulatory approval for research and bioanalysis facilities on both sides of the Atlantic.
Celerion said the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilancia Sanitaria ANVISA) had certified operations at labs in its home city Lincoln, Nebraska and in Belfast, Northern Ireland.
Sites certified by ANVISA will have the review of their submissions expedited, potential reducing the research process. Furthermore, the organization only accepts bioavailability/bioequivalence (BA/BE) work that is completely performed at certified sites,
The clearance therefore could be a real boon for Celerion according to CEO Susan Thornton, who explained its significance for the contract research organizations (CRO) business.
“By earning ANVISA certification to conduct early clinical studies and bioanalytical research for compounds destined for Brazil, Celerion is now able to better serve our clients’ growing needs in this high–growth, emerging market.”
The certification builds on work begun by former Celerion owner MDS Pharma, which first sought ANVISA approval for the facilities in October 2009 as a result of a client request.
Evidently this is a strategy that Celerion, which was acquired by Bain Capital and SV Life Sciences, still thinks is the right approach.
Brazil, whose pharmaceutical market is set to top $18bn (€12.3m) by 2012 according to most estimates, has one of the most rapidly expanding clinical research sectors. And Celerion is not the only CRO that has had its eye on Brazil’s market of late.
However the Celerion’s approach differs from peers like PRA, Covance and Chiltern which have established a physical presence in the country in recent years.
The clinical trials industry in Brazil began to emerge in 1996 when the country moved its rules governing trial more into line with International Conference on Harmonisation (ICH) guidelines and set a national bioethical committee, CONEP, to investigates institutional review boards (IRBs).
This process continued with the passing of resolution 39 in 2008, which enabled ANVISA and CONEP could review trial protocols in parallel process, as it occurs in Europe, potentially accelerating the process by months.
But, while these new rules have increased the amount of research conducted in Brazil, the ability to develop products for the market at sites in Europe and the US may prove to be an attractive option for international pharma firms.
GVK Biosciences said that it has partnered with the Indiana Clinical and Translational Sciences Institute to provide researchers across the US with access to GVK's Clinical Biomarker Database.
According to GVK, the Indiana CTSI Bioinformatics Core and the Indiana Institute for Personalized Medicine will work together to manage the process by which researchers can access the new resource. The database, also known as GOBIOM, is a "comprehensive collection" of biomarkers associated with a variety of therapeutic areas reported in global clinical trials, as well as clinical and preclinical studies.
GOBIOM will be available to researchers at 55 medical centers and universities supported by the Clinical and Translational Sciences Award from the National Institutes of Health.
Hyderabad, India-based GVK noted that the agreement was facilitated by the Indiana Economic Development Corporation during a February economic mission to India.
U.S. generics maker Impax Laboratories says it has started addressing cGMP deviations observed by regulators at California manufacturing plant.
The comment follows an as yet unpublished warning letter from the U.S. Food and Drug Administration (FDA), that detailed a number of violations at Impax’ plant in Hayward, CA, following an inspection late last year.
The quality problems related to sampling and in-process materials testing procedures, as well as to the review process for investigating production failure.
Impax, which conducted a voluntary recall in March of 2011 of five lots of Fenofibrate capsules 200mg, said that it has called in consultants to help it address the deviations, during which time it reduce production levels.
CEO Larry Hsu said: "We don't anticipate that this manufacturing setback will delay our ongoing research and development activities. We expect to continue to develop our generic pipeline of 82 products and two brand products."
Wells Fargo Securities analyst Michael Tong agreed, telling Reuters the letter will not have a long-term impact on Impax’ ability to secure approvals for generic drugs but that it may be hurt in the short term by the slowdown in production.
In other news it has been reported that Impax plans to invest around $52m (€35.6m) to expand production capacity at its manufacturing facility in Taiwan.
The Chunan plant, which was built for $24.5m and became fully operational just last year, currently produces around 450m tablets and, according to an SEC filing, is currently operating at 93 per cent capacity.
According to a report in the San Francisco Business Tribune Impax now intends to increase capacity to around 700m tablets and capsules each year.
Company spokesman Mark Donohue Sr. told the paper that the investment is part of a project that will see the facility manufacturing as many as 1.5bn tablets a year by 2012.
DSM has signed a joint venture agreement with a Chinese biotechnology company that will give the Dutch ingredients supplier its first enzyme manufacturing plant in China.
The agreement between DSM and Yixing QianCheng Bio-Engineering will result in the creation of a new company, DSM (Jiangsu) Biotechnology, based in YiXing, Jiangsu Provence.
Employing around 70 people and consisting of a manufacturing plant, lab facilities and a warehouse, the new joint venture will produce enzymes for brewing, bakery and other food products in China.
“We had shipped enzymes out of the US and Europe before but now we can serve our customers in China directly,” Hans-Christian Ambjerg, president of DSM Food Specialties, told FoodNavigator.com.
Ambjerg said DSM had been in discussions with Yixing QianCheng Bio-Engineering about its QianCheng enzyme business for some time and had been impressed by its people and technology. The company has been established in the Chinese market since 1993 and has built up a broad portfolio of enzymes for the food market.
Ambjerg said that the decision to partner up or go it alone is taken on a case-by-case basis but in this instance setting up a joint venture was judged to be “the fastest and best way” to market.
Under the terms of the agreement, DSM is the majority shareholder with 85 per cent of the shares while Yixing QianCheng Bio-Engineering will hold on to the remaining 15 per cent.
DSM has been building up its food business in China in recent years to get closer to a market that is promising sustainably high future growth. In 2010 the supplier opened up an innovation centre in Shanghai that will work on the development of new products for the Chinese market.
Ambjerg said China has its own particular food products and flavor preferences – he added that these can vary from region to region but that there is generally a big appetite for natural ingredients.
US supplier SAFC has teamed up with Pfenex in a partnership focused on the production of therapeutic proteins and vaccine components.
The non-exclusive collaboration will see Pfenex engineer bacterial strains and develop production processes for SAFC’s customers as part of its contract manufacturing business.
SAFC, the fine chemicals unit of Sigma-Aldrich, will then transfer the processes to its recently expanded current good manufacturing practices (cGMP) quality production facility in Jerusalem, Israel.
In addition, Pfenex will work with SAFC on the production of vaccine components and development of conjugate vaccines through its Reagent Proteins division.
Pfenex spokeswoman Cassidy Brady said that: “The SAFC strategic partnership will focus on identifying customers seeking the total solution, from the design and engineering of a robust production strain, process development and scale up and cGMP production.
“SAFC is offering to subsidize a portion of the upfront costs of strain engineering on behalf of the customer in return for a cGMP manufacturing commitment.
Under the deal Pfenex will receive fees for its strain engineering and process development work as well as licensing fees from SAFC for access to the expression technology.
The SAFC deal is similar to an agreement Pfenex signed with the contract manufacturing wing of Boehringer Ingelheim in February and is further evidence of the platform’s flexibility according Brady.
“Given the rapid adoption of the Pfēnex Expression Technology by large pharma and small biotech companies it behooves CMO’s to add Pfēnex to their portfolio of technologies.”
Pfenex’ approach uses a Pseudomonas fluorescens-based platform technology that, the firm claims, can rapidly produce difficult to express proteins using the concept of parallel processing to expression strain development.
Instead of traditional linear development method, Pfenex’ model allows construction and testing of thousands of unique expression strains combining novel gene expression strategies and host cell phenotypes within five weeks.
This is a distinct advantage according to Cassidy, who claimed the platform has a 90 per cent rate in expressing proteins that have not previously been produced in other systems.
“In addition” she continued “the high titers of soluble active protein that are routinely achieved… enable CMO’s to more efficiently utilize their manufacturing assets and also avoid the need to maintain equipment for refolding insoluble protein.”
Botanical extract manufacturer Chengdu Wagott is to open its second stevia facility in China, which it says will boost its Reb A capacity from 200 tons per year to 500 tons.
Wagott said the facility in Chengdu, China, is due for early completion in September and “will complete another stage in the vertical integration” for its agri-processing-business strategy. Its current facility is in Pujiang County.
The manufacturer is the latest company in the race to boost supply after the market for stevia and Reb A in particular opened up following approval for its use in food in the US, as of December 2008.
The US is Chengdu’s main market but it has its eye on Europe, stating: “Once the EU has permitted the entry of stevia, then the EU market and China will be the exciting markets with great potential.”
There are however already exceptions in Europe as the French government approved the use of Reb-A in food and beverages in September 2009.
A company spokesman told FoodNavigator.com that there are a number of reasons why its Reb A has more of a selling point than other Reb A producers.
He said: “We manufacture the Reb A upon the Phamarcentical GMP standard. We have the organic certifications and we are devoting ourselves to upgrade the taste profiles.
“We have also been granted the patent by USPTO for our extraction methods.”
Reb A (Rebaudioside A) is the sweet good tasting glycoside extracted from stevia plants that is preferred in commercial applications for the food and beverage industry.
Wagott’s Reb A is 95% purity. The company also claims its “ViaSweet” brand has been chosen by leading beverage and food brands as the stevia with the “cleanest” organoleptic (white refined powder) properties, enabling complex product formulations with relative ease.
Michael Wang, Wagott stevia sales manager, said: “Wagott has established itself as a market leader, including having received certification of the "EC organic products" for Europe and "NOP 100% organic products" for United States, issued by the authority of ECOCERT SA.
“The early completion of Wagott’s second facility for a high-purity patented Rebaudioside-A means continued guaranteed supply to global strategic customers.”
During the last decade, Wagott has developed its own controlled agricultural estate for stevia and other natural active ingredients including green tea, milk thistle, pomegranate and rhodiola, according to Hua Jun, President of Chengdu Wagott Pharmaceutical Co.
He added that following raw material cultivation, its quality management system and processing facilities are “as good as or better than any Western country”.
Last month Chengdu Wagott Pharmaceutical was voted in as a member of the International Stevia Council.
DSM has signed a joint venture agreement with a Chinese biotechnology company that will give the Dutch ingredients supplier its first enzyme manufacturing plant in China.
The agreement between DSM and Yixing QianCheng Bio-Engineering will result in the creation of a new company, DSM (Jiangsu) Biotechnology, based in YiXing, Jiangsu Provence.
Employing around 70 people and consisting of a manufacturing plant, lab facilities and a warehouse, the new joint venture will produce enzymes for brewing, bakery and other food products in China.
“We had shipped enzymes out of the US and Europe before but now we can serve our customers in China directly,” Hans-Christian Ambjerg, president of DSM Food Specialties, told FoodNavigator.com.
Ambjerg said DSM had been in discussions with Yixing QianCheng Bio-Engineering about its QianCheng enzyme business for some time and had been impressed by its people and technology. The company has been established in the Chinese market since 1993 and has built up a broad portfolio of enzymes for the food market.
Ambjerg said that the decision to partner up or go it alone is taken on a case-by-case basis but in this instance setting up a joint venture was judged to be “the fastest and best way” to market.
Under the terms of the agreement, DSM is the majority shareholder with 85 per cent of the shares while Yixing QianCheng Bio-Engineering will hold on to the remaining 15 per cent.
DSM has been building up its food business in China in recent years to get closer to a market that is promising sustainably high future growth. In 2010 the supplier opened up an innovation centre in Shanghai that will work on the development of new products for the Chinese market.
Ambjerg said China has its own particular food products and flavor preferences – he added that these can vary from region to region but that there is generally a big appetite for natural ingredients.
BeamOne LLC (Synergy Health Americas Division) is increasing its presence in San Jose, Costa Rica. The company is doubling production capacity at its existing sterilization facility by adding a second beam and building a new ethylene oxide medical device sterilization facility nearby.
In 2009, the wholly-owned subsidiary of Synergy Health plc opened a service center designed to house two electron beams in case capacity someday was needed. The medical device business sector in Costa Rica has grown so much since then that additional sterilization capacity is now required. Both beams will be operational on a 24/7 basis.
“The addition of capacity in BeamOne’s existing Costa Rica [facility] upholds Synergy’s business goal of providing global sterilization services of the utmost quality and performance,” said Richard Steeves, BSc., Ph.D, chief executive of Synergy Health plc. “BeamOne’s record of excellence is substantiated by the obvious need and desire for more electron beam capacity in this exciting Latin America market.”
The new sterilization facility will be located in Alajuela and will become the first service of its kind provided to medical device manufacturers in Costa Rica and surrounding countries. The building will occupy approximately 28,000 square feet, and will require an additional 20 employees to run it when it is operating at full capacity.
Glenn Thibault, chief executive officer of Synergy Health Americas Division, said the additional facility “provides medical manufacturers with the ability to locally sterilize nearly every type of product out of the country for this purpose. The reduced turnaround time and ability to quickly ship through either ocean provides a unique and extremely valuable logistical benefit to manufacturers in the region.”
The installation of the second beam at the existing location should be completed in the second quarter of 2012, according to BeamOne. The new facility should be operational by the fourth quarter of next year.
R-Pharm has purchased a 2,000L FlexFactory bioproduction line from Xcellerex for its new biologics manufacturing facility in Yaroslavl, Russia. The facility represents R-Pharm’s entry into large scale manufacturing of biologics in Russia. The company expects to begin production in 2012. Xcellerex will also provide bioprocess services and training to help ensure rapid and efficient transfer of technology and expertise to support cGMP operations.
“Biologics are revolutionizing the treatment of many diseases,” said Alexey Repik, R-Pharm chairman. “R-Pharm has made a strategic commitment to producing these advanced medicines locally to increase their access and affordability to the Russian people. The FlexFactory and the expertise that Xcellerex are providing will significantly accelerate our development and commercial timelines.”
Xcellerex chief executive officer Guy Broadbent said, “R-Pharm is leveraging Xcellerex’s FlexFactory platform and know-how, proven over 10 years, to fast-track entry into biologics manufacturing. This agreement is an important first step in our strategy to play a key enabling role in the coming wave of Russian investment in biomanufacturing capacity.”
Precision molder and contract manufacturer GW Plastics Inc. is expanding its foreign medical capabilities with the addition of its first manufacturing operations in Costa Rica.
GW said its new joint venture, a medical molding and assembly operation in Cartago, Costa Rica, will start operating this summer, and construction has begun in the city on a new 33,000-square-foot plant scheduled to open early next year.
“We are committed to meeting the global outsourcing needs of our health-care customers,” said Brenan Riehl, president and CEO of the Bethel, Vt., company. “A manufacturing location in Costa Rica will allow us to more efficiently support our customers in Latin America,”
The joint venture, GW Plastics Cartago, is between GW — which is the majority partner — and Corprosemm Corp., a Cartago injection molder and contract manufacturer.
GW Plastics Cartago will start production this summer in Corprosemm’s 10,000-square-foot injection molding plant, which also has an ISO 8 cleanroom room for assembly.
The new plant under construction now can be expanded in the future by one-third to 44,000 square feet, if needed.
The Bethel, Vt., company currently has plants in the Vermont towns of Bethel and Royalton; San Antonio; Querétaro, Mexico; and Dongguan, China. Worldwide, it operates six Class 8 clean rooms.
“GW Cartago will have the same approach to manufacturing as our other locations,” said Arthur Bennert, vice president and chief operating officer of GW Plastics. “Coupled with Corprosemm's medical-device experience, [it] will allow us to offer unparalleled manufacturing support to our health-care customers in the region.”
Cetero has inked an early stage preferred provider agreement and is eyeing other deals as sponsors look to extend the partnership model into Phase I.
Entering into strategic relationships with a limited number of contract research organizations (CRO) has allowed sponsors to consolidate their vendor networks. Most of these deals focus on Phase II to IV clinical trials but the model is now extending into early phase and Cetero Research hopes to benefit.
“We've been selected by a top pharma in a preferred provider deal”, said Troy McCall, CEO of Cetero, told Outsourcing-Pharma. Cetero is in active discussions about strategic partnerships with other sponsors and is monitoring opportunities as companies reach the points in their cycles when early phase deals are inked.
With 1,500 early phase beds in North America Cetero is well placed to enter into these deals. The early phase unit at Icon has 250 beds, which Peter Gray, CEO of the Irish CRO, said is sufficient to compete for strategic partnerships.
Parexel, which has 580 beds ahead of upcoming cuts, has also spoken of competing for early phase strategic deals, but with a large network and considerable experience Cetero is confident of its position.
“We're quite comfortable with the capacity we've in place”, said McCall. A number of large CROs, most recently Parexel, have made early phase cuts and spoken of over-capacity but McCall claims Cetero has fared better.
McCall attributed the resilience of early phase at Cetero to the CRO's focus on that stage of development. Cetero is also less linked to the fate of innovator biopharm because of its strong portofolio of generic clients.
Cetero was formed in 2006 when private equity backers began acquiring and consolidating early phase CROs. Since then private equity ownership of CROs has increased as financial players look to profit from the sector.
The owners of Cetero are “long-term players”, said McCall, and will back the CRO as it works to cement itself in a leading position in the early phase sector.
Quintiles’ Egyptian contract sales and marketing partnership began commercial activities, further expanding the firm’s presence in what it says is one of the world's most rapidly expanding regional markets.
The joint-venture (JV), which was announced last October , sees Quintiles team up with Egypt’s Kare Pharma International (HKPI), and Ramco Import and Export to create a contract marketing organization.
And, while the precise details of collaboration have not been disclosed, it is understood that Quintiles will bolster Ramco’s 40-strong sales team with marketing capabilities developed by its global teams.
The Egyptian partnership model is similar to the one Quintiles uses in neighboring Turkey where it operates a joint venture with a leading local company, Bell Holding.
The local knowledge that its partners provide is key according to Quintiles’ VP, product development and commercialization Jim Featherstone who told Outsourcing-pharma.com why the firm opted for the collaborative approach.
“We already have an established clinical business in both Egypt and Turkey, which provides us with insight and experience of the country and its legislative processes.
“However we believe that we can provide the best solutions for our customers, both within Egypt and for global biopharma customer wanting to enter these markets by partnering with best in class, local companies that have intimate knowledge, experience and expertise in delivering commercial solutions locally.”
Featherstone went on to say that both countries are a huge opportunity for pharma, explaining that: “Turkey and Egypt are growing at more than 12 per cent per annum with…. a greater focus on improving healthcare.”
German transdermal drug developer, Labtec, has opened what it claims is Europe’s most modern manufacturing facility for the production of transdermal drug delivery systems (TDS) and oral dispersible films (ODF) using its proprietary RapidFilm technology.
The new unit took one and a half years to complete, and is located within parent company tesa’s largest manufacturing site, tesa Werk Hamburg GmbH, just south of the German city of Hamburg.
Labtec says the facility provides industrial mass production services, and features state-of-the-art coating and drying lines with variable coating widths, as well as modern slitting machinery and high-precision, flexible converting and packaging equipment dedicated to TDS and ODF finished products.
Ingo Lehrke, managing director of Langenfeld-headquartered Labtec, said the company was pleased to have the new facility up and running in such a timely fashion, and paid compliment to the contributions made to its construction not only by tesa experts, but also those of Hamburg-based skincare specialists, Bieresdorf Medical.
“It took only one and a half years from the initial planning phase until completion of construction and start of operation of the unit,” he said.
“This quick implementation is the result of an extremely close and dedicated cooperation between experts from tesa, Bieresdorf and Labtec. We are now able to combine Labtec’s pharmaceutical know-how with tesa’s extensive manufacturing expertise to supply our customers with innovative drug delivery products.”
According to Labtec, the new Hamburg plant operates a cleanroom environment, and is certified as fully good manufacturing practice (GMP) compliant following a three-day inspection by Hamburg’s health authorities in March this year.
Tesa finalized a deal for Labtec in November 2008, as it sought to focus its efforts on burgeoning markets in the healthcare sector.
Consequently the company – which is a leading manufacturer in the production of self-adhesive products and solutions for industry, trade and consumers – saw the acquisition of Labtec as “the next logical step” in pursuing its strategy of tapping into “high-yield markets of the future”.
Quotient Clinical, a business unit of Quotient Bioresearch, announced the completion of a major expansion of its clinical facilities in Nottingham, UK. Bed capacity has been increased by 50 per cent and a dedicated sample processing laboratory for human ADME studies has been incorporated. The new facilities have been inspected and approved for use by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), and have been awarded Supplementary Accreditation.
The expansion is a direct response to increasing customer adoption of Quotient’s Synthesis-to-Clinic platform, in particular in support of human ADME studies, and reinforces Quotient’s position as a leading provider of 14C-enabled drug development services including Phase 0 microdose, ivMicrotracer, and human metabolism studies.
Synthesis-to-Clinic integrates each component required to undertake a 14C-enabled clinical study into a single supply chain, spanning 14C API radiosynthesis through to the clinical study report. The ability to seamlessly deliver such a program under a single contract, with a single project manager and continuity of scientific input throughout, delivers significant benefits to the drug development project team.
Mark Egerton, MD Quotient Clinical, commented: “In parallel with the recent expansion of our Pharmaceutical Sciences laboratory and GMP drug product manufacturing facility, the completion of this clinical expansion is another milestone in the development of our business. It underlines the strength of our Synthesis-to-Clinic platform and the benefits it brings to our global client base. Our expanded facilities will assist the continued development of our services, supporting our customers in taking new and innovative approaches in early drug development.”
SGS plans to
open its second Life Science Services facility in Mumbai, India, which is
expected to be fully operational by mid-2012. This investment will establish a
dedicated GMP lab to provide a range of analytical development and quality
control testing services. It includes a lab for new or expanded services in
stability testing, extractables and leachables, analytical chemistry, and
microbiology. SGS will also invest in the latest generation of mass
spectrometers and stability chambers to increase testing and sample storage
capacities. The 15,000-sq.-ft. facility will initially employ 20 staff and as
many as 90 additional positions in the next five years.
“This investment is part of the three-year growth plan for SGS India and the
Life Science Services division,” said Anne Hays, executive vice president for
SGS Life Science Services “With the growth of the pharmaceutical market in
India, and specifically Mumbai, SGS takes this initiative to be in physically
closer to our customers, while maintaining the quality we deliver, building our
service offerings, and expanding our global network of laboratories.”
Laboratory Corporation of America Holdings announced that it has entered into a definitive agreement to acquire Clearstone Central Laboratories, a leading global provider of central laboratory services for late-stage clinical trials. The transaction, which is subject to customary closing conditions, is expected to close in the second quarter of 2011. Terms of the agreement were not disclosed.
"This acquisition fully combines the complementary strengths of the Clearstone and LabCorp clinical trials businesses to support drug development," said David P. King, Chairman and Chief Executive Officer of LabCorp. "This transaction is an important milestone as it extends our global footprint and service capabilities in key geographies such as Asia Pacific, and advances the Company's companion diagnostics and personalized medicine strategy." The agreement provides LabCorp with Clearstone's global network of central laboratories and clinical trials management system APOLLO CLPM(TM), which provides clients with real-time access to global data, strengthened chain of custody, automated sample stability monitoring and guaranteed consistency across all lab sites. The combined entity will have the largest available biomarker assay portfolio with globally harmonized and state-of-the-art testing platforms in areas such as pharmacogenomics, microbiology, immunohistochemistry, allergy testing, cytogenetics and flow cytometry.
"We are pleased to announce this agreement because of the growth opportunity and long-term strategic value it creates for our clients," said Clearstone CEO Lewis Cameron. "Clearstone has already been working closely with LabCorp's Esoterix division under a strategic collaboration agreement, which has resulted in a number of client success stories. We will now be a single team that is completely focused on exceeding our customer's drug development objectives."
Clearstone is expanding safety and esoteric capacity at its laboratory in Toronto, Canada, allowing it to close its facility in New Jersey, US and consolidate North American operations.
The New Jersey site mainly performs esoteric testing and by expanding the Toronto laboratory Clearstone will be able to consolidate without losing capacity or capabilities, said Lammert Albers, vice president, global business development at Clearstone.
Clearstone will wind down operations at the New Jersey site over the next six months. Closure of the site will result in “a few job losses” but Clearstone is aiming to retain and relocate some employees, added Albers.
Following closure of the New Jersey laboratory Clearstone will transfer remaining studies to its site in Toronto. Adding safety, esoteric and enzyme-linked immunosorbent assay (ELISA) testing, as well as flow cytometry, will allow Clearstone to cope with the transfer and meet client needs.
Albers added that there are more changes and developments in the pipeline at Clearstone.
Clearstone went through a lull between MDS announcing the sale and completion of the transaction, said Albers, adding that “it was a tough time”.
Customers remained positive and supportive though and Clearstone is now seeing a resumption of relationships and the creation of new business, according to Albers.
Activity includes a deal with Eli Lilly. Clearstone is providing Lilly with services from its site in Beijing, China which has been expanded by adding the Affymetrix DMET system to support the deal
The Beijing site was occupied just prior to the Olympics in 2008 and has five times more capacity than the previous site.
Contract research organization (CRO) Clearstone Central Laboratories has unveiled a ‘preferred provider’ partnership with Mitsubishi Chemical Medience (MCM), continuing its efforts to expand in Asia.
The deal grants Canada-headquartered Clearstone access to MCM’s 21-strong network of contract clinical and diagnostic laboratory facilities that extends across Japan.
In return, MCM and its customers will be able to use the Canadian CRO’s global laboratory facilities, including its recently expanded lab in Beijing, China and its unit in Singapore.
Spokesman Bernie Clark said that: “Clearstone has been working with Mitsubishi over the last year in a similar fashion and we are now at a point where we can publicly announce the partnership,” adding that the deal stands to benefit both parties.
He went on to explain that while Clearstone does not have any lab facilities in Japan, it does service a large number of trial sites in the country and added that access to MCM’s labs will provide customers with more options.
The MCM deal is also similar to an agreement Clearstone formed with Lab Corp’s Esoterix Clinical Trial Services unit late last year, which granted the latter firm access to the Beijing laboratory.
More broadly the new partnership, financial terms of which have not been disclosed, is in keeping with the global expansion strategy Clearstone set out for 2011.
In February the Canada-headquartered CRO said that its plan was to build its presence in the Asia-Pacific region through the formation of strategic partnerships with local players.
Clark confirmed that this is still the case even after the MCM partnership, telling Outsourcing-pharma.com the firm “will continue to look for unique and innovative solutions and relationships that help our clients streamline and accelerate their clinical research programs.”
Bilfinger Berger has won a €30m ($43m) contract to help Genzyme add 8,000L of production capacity at its site in Geel, Belgium.
Genzyme began work on the €250m production plant in January to add capacity to support the long-term growth of Myozyme (alglucosidase alfa). Having previously performed work for Sanofi, Genzyme’s new owner, Bilfinger Berger Industrial Services (BIS) has picked up the Geel deal.
“We are very pleased that we were able to prevail over renowned peers. The project in Belgium will allow us to additionally extend our international activities”, said Ludwig Paradeiser, general manager of BIS Industrietechnik Salzburg.
BIS is supporting construction of the plant by taking responsibility for apparatus assembly and the piping systems. The PM Group is the general architect for the plant and selected BIS for the work after the companies collaborated on a Sanofi plant last year.
Sanofi contracted the PM Group to do engineering design for its €200m cell culture plant in Vitry-sur-Seine, near Paris, France. BIS installed tanks, pumps, heat exchangers and filters at the plant and will now do work for Genzyme, which Sanofi acquired in April.
Genzyme is building the plant, which consists of two 4,000L bioreactors for producing Myozyme, as part of efforts to increase capacity four-fold. By expanding at Geel Genzyme expects to add 150 staff, bringing total employment at the site up to 600.
BIS is targeting the biopharmaceutical industry as a growth sector and has made acquisitions to strengthen its position. Winning business from Sanofi and Genzyme furthers this strategy.
“Projects attracting a great deal of international attention such as the recent one in Paris and now also in Belgium confirm the reputation which BIS has acquired in the [biopharm] segment”, said Joachim Kreysing, executive vice president of the BIS Group.
In August 2010 BIS also inked a five-year, €50m maintenance services and plant support deal with Switzerland-based Siegfried AG. As part of the deal BIS took on 50 Siegfried employees.
GE Healthcare announced the opening of its new technology facility at the Science for Life Laboratory (SciLifeLab) in Stockholm, Sweden.
The lab is furnished with GE's tools and technologies for protein, cell biology, and biomedical research and intends to collaborate with SciLifeLab researchers in human disease. A full-time GE manager and two technical specialists will staff the lab.
Matthias Uhlén, director of SciLifeLab Stockholm, said in a statement, "Our vision for SciLifeLab is to create a world-leading center for molecular biosciences and medical research to foster greater understanding of the nature of human diseases. GE's demonstration laboratory will be a significant and positive addition to the SciLifeLab."
SciLifeLab was founded in 2010 as a joint collaboration between the Royal Institute of Technology, Karolinska Institute, and Stockholm University, and serves as a national resource center to enable large-scale molecular biosciences and biomedical research in Sweden. In addition to Stockholm, it has facilities in Uppsala, which is managed by Uppsala University.
The Swedish government provides the majority of SciLifeLab's funding.
SAFC operates a contract manufacturing fermentation facility in Jerusalem, Israel. The facility is
EU and FDA compliant and has been designed to meet the statutory requirements at all stages of the drug development process. It offers fermentation based high potent active pharmaceutical ingredients (API) development on a large scale.
A $25m expansion to the facility was completed in October 2010. The expansion has boosted the capacity for the development and production of large-scale, high-potency, toxic or dangerous drug substances, including secondary metabolites cytotoxins and large-molecule proteins. The expanded facility is expected to begin operations in 2011.
The facility spans 50,000ft² and accommodates custom designed Class 100,000 (ISO 8) fermentation and harvesting manufacturing clean rooms that have been designed to meet the most stringent requirements of biohazard fermentation and HPAPI manufacturing.
"A $25m expansion to the facility was completed in October 2010."
Each fermentation and harvesting room is installed with biohazard cabinets. The suites are equipped with a range of fermentors of 19l, 100l, 1,000l and 4,000l capacities for both batch and fed-batch operations. The suites are additionally installed with temperature-controlled stirred processing vessels, fully automated piston discharge high-speed centrifuge, continuous disc stack centrifuge and high-pressure homogenizer.
The facility is designed to operate at Biosafety Level 2. Approximately 30,000ft² of the facility's area is Biosafety Level 2 compliant, allowing the manipulation of risk-group 2 microorganisms.
The Class 100,000 (ISO 8) recovery cleanrooms are designed with an explosion proof environment. There are segregated Class 10,000 (ISO 7) purification clean suites that are installed with Class 100 (ISO 5) safety cabinets. Each manufacturing area is airlocked and provided with 100% HEPA filtered single pass air by a HVAC system. The setting prevents cross contamination, besides protecting the environment and ensuring the safety of the personnel.
The biohazard cabinets generate master and working cell banks of natural or recombinant microorganisms up to Risk Group 2 (RG2) pathogens. The purpose built banks are housed within temperature controlled biostorage inside the facility.
"The expanded facility is expected to begin operations in 2011."
The facility is also equipped with Fast Protein Liquid Chromatography (FPLC), Medium Pressure Liquid Chromatography (MPLC) and Cross flow process scale ultra / diafiltration capabilities. A 550l evaporation train is also installed. Additional equipment within the facility includes 200l liquid-liquid extraction column and Lyofast 5 pharmaceutical freeze dryer. All equipments are jacketed and explosion proof. The facility has the required cleaning and sterilization / sanitization in place (CIP, SIP) systems.
The facility develops therapeutic proteins through fermentation technology. The main technologies adopted include yeast fermentation, fungi fermentation and bacterial fermentation. Microorganisms including bacteria, streptomycetes, filamentous fungi and yeast are cultivated. During the process, microbial growth kinetics and homogeneity of the culture is continuously monitored. Temperature, pH, agitation, pressure and turbidity are also monitored throughout the process of fermentation. Using suitable analytical methods, any accumulation of product or impurities is also monitored during the process.
After meeting a pre-specified criteria including physical, microbial and product accumulation endpoints, the culture is harvested to separate the biomass or broth. From the fermentation broth or the biomass, the native or recombinant proteins are recovered. Yields are optimized through both upstream and downstream process development.
The facility is equipped to perform downstream processing of aqueous products and organic solvent based products. The primary technologies include centrifugation, homogenization, concentration, separation, process chromatography, organic extraction, and adsorption.
During the final phase of purification, the desired product is separated at the highest purity level and retained.
The facility develops and manufactures therapeutic proteins to support client requirements from the pre-clinical to the commercialization stage. It uses E.coli, streptomyces sp., filamentous fungi and yeast, including risk group 2 human pathogens to develop multiple products including secondary metabolites, cytotoxins and highly-potent large-molecule proteins.
Analytical services offered by the facility include analytical method development and validation, raw material, in process and final product release testing, stability testing and cleaning efficiency testing.
SCHOTT Pharmaceutical Systems, one of the world's leading suppliers of glass tubing and primary packaging for the pharmaceutical industry, continues to expand its global network. The company will open up a new production plant in Russia this month and plans to further strengthen its position in Japan.
At the end of May 2011, the company will officially inaugurate a new manufacturing facility in Russia. Located in Zavolzhe, near the Russian city of Nizhny Novgorod, the new production site will employ around 60 employees initially and will produce premium quality ampoules and vials. All products will be manufactured according to cGMP guidelines (current Good Manufacturing Practices) and meet the high international standards for primary pharmaceutical packaging.
SCHOTT is the first international group, which manufactures primary pharmaceutical packaging made of glass, to open a production facility in Russia. With its packaging expertise and quality commitment, SCHOTT will support Russian pharmaceutical companies in meeting the requirements of 'Pharma 2020'. The company has been selling ampoules, vials, cartridges and syringes to the Russian market since the beginning of the 1990s. So far, Russian customers have been mainly supplied from the existing pharmaceutical packaging site in Hungary.
Furthermore, SCHOTT formed a joint venture with Japanese company Naigai Glass Industry at the end of 2010 in order to strengthen its position in Japan, the world's second largest pharmaceutical market. The new company, SCHOTT NAIGAI K.K., is based in Osaka, Japan, where Naigai has already been operating a production site for many years. Under the terms of the joint venture, Naigai shifted its existing vial manufacturing activities over to the new company and SCHOTT contributed its highly advanced automated inspection system (AIS), which is even more reliable than human eye inspection.
With new business operations in major growth markets such as China and Argentina, SCHOTT has already expanded its global network of pharmaceutical packaging production plants in recent years. With more than 600 production lines in 14 countries around the world, SCHOTT manufactures over seven billion syringes, vials, ampoules, cartridges and special products for the pharmaceutical industry each year.
"Our global production network allows us to be close to our customers who benefit from the high quality and technology standards," says Dr Jürgen Sackhoff, executive vice president of SCHOTT Pharmaceutical Systems. “These global production capacities also allow for supply safety along the entire supply chain.”
Switzerland-based life sciences supplier Lonza says it will invest CHF10m (€8m) to expand a Singapore plant that is part of its custom biomanufacturing business.
The investment will add nearly 2,000sq.meters (21,520 sq. ft.) of laboratory space at the facility in the Tuas Biomedical Park to support Lonza’s contract cell line development, processing and analytical services businesses.
Lonza did not respond to a request for comment and has not said if it will hire new staff or if the expansion will have any impact on the facility in Slough, UK that is the current base for its custom biomanufacturing unit.
In a press statement spokeswoman Lonza’s Janet White said the expanded facility, which is due to be fully operational in 2012, will cater for customers across Asia and around the world.
“This further investment in our Singapore location is driven by the increased demand we are seeing on a global basis.
“We are looking forward to offering the full range of our GS Gene Expression System and other technologies in Asia. The location is advantageous to many of our customers from across the globe, and in particular, with our growing set of customers based in the region.”
News of the Lonza's expansion plan follows just weeks after Singapore’s Ministry of Trade and Industry (MTI) raised its estimates for the country’s economic growth to between 5 and 7 per cent, citing the biomedical sector as a driver.
At the time MTI deputy secretary Kwek Mean Luck said that: "The manufacturing sector rebounded by 75 per cent on a (quarter-on-quarter) sequential basis.
“This was due to a strong boost from the biomedical manufacturing (BMS) cluster, resulting from a higher value-added mix of active pharmaceutical ingredients being produced.
This was echoed by analysts one of whom, Wu Kun Lung from Credit Suisse, highlighted Lonza among the most important contributors.
"This year, there are new plans by Lonza, GSK. And last year, we have new expansion by Roche and we already seen how much it can boost GDP growth. And given this year, we have more new plants coming on stream. There definitely could be more upside surprises here."
Lonza will spend $23 million to expand capacity at its Slough, England, biologic manufacturing facility by the end of 2012. The project entails the construction of a 60,000 sq. ft. building adjacent to the existing facility, a new fermentation suite, purification suites, and development labs.
Helsinn Advanced Synthesis (HAS), a division of the Helsinn Group of Switzerland, is building a new CHF20m (€15.4m) cytotoxic plant in Biasca. The engineering designs have already been drawn up as space was allocated for this expansion when the HAS facility was originally built in 2000. Approval for the extension was given in January this year.
Paolo Guainazzi, HAS’ general manager, says Helsinn’s expertise in highly potent compounds means that moving into the cytotoxic market will be a smooth transition and the firm will be able to begin commissioning laboratory projects in the first quarter of 2012.
The laboratory will include dedicated areas for R&D and QC and a small-scale GMP area will be available for the production of reduced quantities of cytotoxic APIs for clinical and registration purposes (grams to hundreds of grams). The layout, personnel, and material flow for the lab and production area will be completely independent of the existing API production plant.
The cytotoxic plant will have two different production areas, each processing one product at a time. The first will have three reactor units: a 250L S.S. glass-lined reactor; a 250L Hastelloy C2000 reactor; and a 400L Hastelloy C2000 Reactor. The section will also include a 0.125m3 Hastelloy C2000 filter dryer within a glove box. This area will be able to produce 10kg batches.
The production areas will each have reactors and a filter dryer and will be able to produce 10kg and 20kg batches, respectively
The second production area will also have three reactor units: a 630L S.S. glass-lined reactor; a 630L Hastelloy C2000 reactor; an 800L Hastelloy C2000 reactor; and a 0.25m3 Hastelloy C2000 filter dryer within a glove box.
The operating conditions in the production area will range from –80°C to +160°C with full vacuum up to +6 bars for pressure.
Helsinn Advanced Synthesis has been manufacturing Category 3 molecules (OELs ranging from 30ng/m3 to 10μg/m3) for more than 10 years in the existing highly potent facility. The new cytotoxic plant will be able to handle Category 4 molecules (OELs less than 30ng/m3).
Essex-based Europlaz Technologies, a leading manufacturer of plastic medical devices and components, has installed a third, Class 7 cleanroom as the company continues to expand its medical device manufacturing facilities.
Growing demand for complex molding and assembly has provided impetus for expansion and the company’s 300-tonne Kraus Maffei machine is believed to be one of the largest molding machines to be housed in a cleanroom in the UK.
“Our can-do attitude and emphasis on quality have made this growth a necessity,” says Eddie O’Keeffe, managing director of Europlaz. "In 2010 we partnered several OEMs on the design and development of new products so production has hit the ground running in 2011.”
More than £500,000 has been invested in Europlaz facilities in this first stage of expansion, and although the new cleanroom was built out of necessity, Europlaz expects this growth to enable the company to expand its partnerships with medical OEMs at home and abroad.
Europlaz has expertise in improving existing devices, in terms of cost or manufacturability, or making a reality of novel idea still on the drawing board. With three state-of-the-art manufacturing and assembly cleanrooms and on-site design and tooling facilities the company says it is well placed to be a one-stop-shop
NSF International, an independent public health and safety organization headquartered in Ann Arbor, Michigan, US, has opened a new NSF Shanghai Testing Laboratory in China, expanding its services in Asia to include testing in food equipment, dietary supplements and ingredients, excipients and consumer products.
Additionally, the facility will provide on-site training in HACCP and GMP, GLP, quality and regulatory compliance for these sectors.
The 11,000m2 (118,360 sq. ft.) laboratory complements NSF’s existing certification services in China and provides a means to source safer products, raw materials and ingredients from Asia through independent, third party testing and certification.
Headed by laboratory manager Dongjing Liu, the lab will work with NSF Shanghai Co, a joint venture between NSF International and the Shanghai Audit Centre of Quality System (SAC) set up in 2005 and approved by the Certification and Accreditation Administration of the People's Republic of China (CNCA), to support product certification for companies in China making food equipment, dietary supplements and other consumer products and streamline the import/export process.
The NSF Shanghai Co joint venture also offers management systems certifications (e.g. ISO 9001, ISO/TS 16949) and global food safety certification.
‘NSF International is pleased to bring its testing and technology services to China and Asia. The combination of Asia’s growing export market and the need to ensure the safety and quality of raw materials, ingredients, consumer products and food creates a greater demand for third-party testing and certification services from a reputable organization like NSF International,’ said Lori Bestervelt, NSF International senior VP and chief technical officer.
‘The opening of the NSF Shanghai Testing Laboratory will help companies in Asia ensure the quality of their materials, demonstrate compliance with international public health standards, and conserve resources by eliminating the need to ship product to the US for testing.’
Watson Pharmaceuticals, Inc. has formally announced an approximately $44 million expansion of its Salt Lake City, Utah, Watson Laboratories, Inc. site. This facility is Watson's state-of-the-art pharmaceutical research, development and manufacturing facility for transdermal patches and topical gels. Governor Gary R. Herbert toured the facility and participated with Watson's President and Chief Executive Officer, Paul Bisaro, in ceremonies marking the expansion.
The Salt Lake City expansion includes retrofitting approximately 20,000 square feet of existing space and the construction of approximately 17,000 square feet of future manufacturing space. The company anticipates the expansion could ultimately result in the addition of approximately 300 employees within the next 3-5 years. The expansion supports a potential tripling in annual manufacturing batch capacity to support future new products, including the generic version of the Lidoderm® transdermal pain management product, which the company may launch as early as mid to late 2012. It will also support Watson's expansion of transdermal and topical gel products manufactured in Salt Lake City into select international markets.
"We are committed to expanding our presence in Salt Lake City, which is our center of excellence for the manufacture of brand and generic pharmaceutical products that utilize topical or transdermal patch drug delivery technologies. This expansion not only supports our near-term product manufacturing and packaging needs, but also positions us to more efficiently meet anticipated future consumer demand for products that are currently in various stages of development," said Paul Bisaro, President and CEO.
"This expansion is more than just bricks and mortar. We are investing in the creation of skilled manufacturing, packaging and quality control/quality assurance and other jobs that will create opportunities for the population of Salt Lake City and the surrounding areas. We are delighted to have Governor Herbert join us in commemorating Watson's significant investment in the future of our Company and in the future of the Salt Lake City community."
Watson's Salt Lake City facility is the headquarters for the Company's Global Brands research and development operations, with approximately 175 professionals involved in product development. In addition, the Salt Lake City facility manufactures and packages brand and generic transdermal patch and topical gel pharmaceutical products, and currently employs more than 200 people in manufacturing and operations.
MTC Insulation Solutions has been awarded the second phase of a £2m project after its initial factory design enabled contract packaging company Wasdell Packaging to cut its production times.
The Solihull, West Midlands-based design and build specialist constructed a 5,574m2 (59,976 sq. ft.)factory for Wasdell last August. The A+, BRE Green Guide-rated factory exceeds Good Manufacturing Practice (GMP) and has been such a success that the company has now moved into 24/7 working and requires a new cleanroom.
Geoff Daren, commercial director at MTC Insulation Solutions, says he is delighted to have been awarded the second phase of the project for Wasdell Packaging.
In the second phase, MTC will build an 800m2 (8,608 sq. ft.) cleanroom, including seven production lines, insulated walls, ceilings, a mezzanine extension and ventilation work to prevent over-cooling within the plant.
The £500,000 project is expected to be completed in May and will increase Wasdell Packaging’s capacity by a further 75 percent.
Ameridose, a US provider of sterile admixing preparations and pre-filled syringes to hospital pharmacies, has opened its third manufacturing facility in Westborough, MA.
The new 70,000 sq. ft. facility contains state-of-the-art cleanroom equipment, including an HVAC system with energy efficient condensing boilers and ultrasonic humidification.
In addition, more than 400 fan-powered HEPA filter units rated at 99.9% efficiency and featuring motion sensor controls have been installed in the shipping, receiving and warehouse areas.
Now operational, the facility complies with Ameridose’s corporate sustainability policy which requires the recycling of all paper, glass, metal, plastic, corrugated cardboard, wood, and computer/electronic waste.
The company said more than 90 percent of the construction-related waste was recycled.
“This is the largest, state-of-the-art sterile admixing and repackaging facility in the nation,” said Sophia Pasedis, VP of regulatory affairs and compliance at Ameridose. “The new facility expands our capacity to accommodate new business and to offer current customers the security of back-up facility.”
Ameridose provides high-quality sterile, admixed and repackaged preparations and oral repackaging services. An FDA-registered manufacturer, the company exceeds USP 797 standards and meets cGMP requirements.
Gov. Deval Patrick and Boston Mayor Thomas Menino were among those attending a groundbreaking for the new South Boston headquarters of biotech giant Vertex Pharmaceuticals Inc.
Vertex's move from Cambridge boosts Menino's plan to create an "Innovation District," featuring high tech companies that can attract young workers and new business.
In May, Vertex got regulatory approval for a hepatitis C treatment that the company believes can be a best-selling drug, clearing the way for the move and groundbreaking.
Vertex new office will be built at Boston's Fan Pier, which has seen recent activity after struggling for decades amid stalled development proposals. Plans call for an eight-building complex there. Vertex says it will lease 1.1 million square feet of office and lab space at two of the buildings.
Biotechnology company Medicago has secured a $5.6 million milestone payment from the federal government as the company nears completion of a new vaccine plant in Research Triangle Park, North Carolina intended to respond to future pandemics.
Quebec City, Canada-based Medicago could receive up to $21 million from the Defense Advanced Research Projects Agency, or DARPA, which last August pledged the money to the company to demonstrate scalable manufacturing of its vaccines using its proprietary technology. The facility is part of DARPA’s “Blue Angel” project, which aims to develop new ways to rapidly produce large amounts of vaccine in response to infectious disease and bioterror threats. Medicago has been awarded $16.3 million in milestones to date.
Medicago’s technology can make virus-like particles from tobacco plants. The company says that the technology offers speed and cost advantages compared to other vaccine technologies, which makes it particularly suited to respond to pandemic strikes.
Mike Wanner, vice president of Medicago’s U.S. operations, projects that the facility will be operational in the second half of 2011. The company expects the facility will have the capacity to produce 10 million doses of influenza vaccine a month with the capacity to expand in the future.
Syngenta Biotechnology, Inc., has announced plans to begin construction on a $71 million state-of-the-art biotechnology research facility in Research Triangle Park.
Building on recent successes in delivering agronomic traits for growers, the new 147,000 square foot research and development complex will provide Syngenta researchers the environment to pursue new traits that will help farmers grow more from less.
The new site will include all-glass, climate-controlled greenhouses and precision growth chambers, which, borrowing from technology developed by NASA, will offer complete control of multiple growth variables, including water, nutrients, light and atmospheric gases.
“We’re very excited about the capabilities this new facility will enable,” said Michiel van Lookeren Campagne, president of Syngenta Biotechnology. “These sophisticated growth environments will help our researchers study traits with greater precision and efficiency, ultimately leading to discoveries that will enhance plant productivity.”
Utilizing the new growth environments, scientists will isolate environmental elements in order to study their effects on specific agronomic traits, focusing on improving crop yields by combating plant stresses such as drought and insect pressures. Research will be performed on key crops including corn, soybeans, sugar cane, rice and vegetables.
“Biotechnology is a sector that did not exist a century ago but is today a major driver for many national and regional economies, including North Carolina's,” Gov. Bev Perdue said. “We can only compete in this kind of high tech industry by continuing to invest in our people -- and that means protecting our public education system must be our top priority. Syngenta picked North Carolina in part because they know we can produce highly skilled, well educated workers."
The new facility will be located adjacent to the company’s existing campus in Durham County. Syngenta expected to break ground on the new site in June.
“We’ve been operating in RTP for more than 25 years and the community here has been very supportive of Syngenta and its employees,” continued van Lookeren Campagne. “Through our employees’ enthusiastic support of Syngenta’s community outreach initiatives, we’ve grown to become an integrated member of this vibrant region.
“North Carolina is a leader in agricultural biotechnology, and close ties with academic and research institutions provide an environment that fosters innovation. I want to thank Durham County, the State of North Carolina, the North Carolina Biotechnology Centerand the Greater Durham Chamber of Commerce for their support.”
Syngenta Biotechnology opened its doors in Research Triangle Park in 1984. Since that time, the company has expanded its facilities and employment in the park, which now include greenhouses, laboratories and administrative offices.
Syngenta Biotechnology, Inc. is a leading innovator and collaborator in plant genetics and serves as the global headquarters for plant biotechnology research and development for Syngenta. The company employs approximately 400 people at its RTP campus. The company was ranked in 2010 as the No. 7 science employer in the world by Science magazine.
Syngenta is one of the world's leading companies with more than 26,000 employees in over 90 countries dedicated to our purpose: Bringing plant potential to life. Through world-class science, global reach and commitment to our customers we help to increase crop productivity, protect the environment and improve health and quality of life.
Symetic has opened a new lab facility to showcase its range of processing systems to the pharmaceutical manufacturing, packaging and nutraceutical sectors.
The 31,500 sq. ft. laboratory in Walla Wall Washington, U.S., houses a demonstration area where pharmaceuticals firms can analyze their products and a separate unit where they can conduct factory acceptance testing (FAT) on developmental processes.
Jon Donovan, Product Manager for Symetix said: “Our new Innovation and Solutions Center reflects Symetix and Key Technology accurately with a modern, technology-based environment for demonstrating and testing equipment based on each customer’s requirements.”
One of the key features of the new facility is a live video feed that allows those unable to travel to Walla Walla to demonstrations or application tests as those present and make observations and ask questions in real-time while their product is being run.
Protein analytics firm BioScale Inc. has opened its new 30,000-square-foot laboratory and manufacturing headquarters in Lexington, where the company said it plans to add more hires in supply chain, sales, service, marketing, manufacturing and operations.
The new facility will support the company’s research and development and instrument manufacturing, as well as the manufacturing of its consumable MEMS sensor cartridges and reagents.
“The positive response we have received from the launch of BioScale’s ViBE product line required us to grow our facility and functionality,” BioScale CEO Mark Lundstrom said in a statement. “We’re building out additional sales, marketing, manufacturing, and application development areas. This growth required a new, better equipped, and larger facility to enable the company to realize its full potential.”
Founded in 2002 by CEO Mark Lundstrom and three MIT professors, BioScale develops its ViBE protein analytics system, intended to deliver ultra-sensitive detection of proteins in bioprocessing, research, clinical, point-of-case and personalized medicine.
The company landed a $25 million funding round in June 2010, led by Morningside Venture, with return backers New Science Ventures, WFD Ventures and F2 Ventures.
Sanofi has established the Sanofi Boston R&D Hub in Massachusetts to integrate its research and development activities with those of Genzyme, which will keep its name and continue to operate as a stand-alone company under Sanofi. The Genzyme R&D Center will operate within Sanofi's R&D hub and will focus on the development of Genzyme's drug candidates for rare diseases and Sanofi's experimental treatments for multiple sclerosis.
HAWAII'S decade-old vision of launching a vibrant life sciences industry to diversify the state economy hasn't come to fruition, though scientists still hope it will.
At the core of this vision is the University of Hawaii, John A. Burns School of Medicine, which opened its campus in Kakaako in 2005 and was touted as the magnet to attract high-technology companies that would share research and lucrative ventures.
That critical mass was never established partly because of economic problems that prevented installation of costly laboratory and research space for companies that develop biotechnology, health therapies and medical devices.
"It's (the life sciences industry) still floundering; we don't have a set direction," said J. David Curb, the med school's director of translational research and former CEO of the Pacific Health Research Institute, a Honolulu-based biomedical research organization. "Currently, we just don't have the organization we need to make it happen. I think a lot of people are really not sold (on the idea) that we need this. It doesn't grow by itself."
Even so, there were at least a dozen high-tech firms created in the last decade that are working toward commercializing research. Some biotech collaborations have extensive partnerships with the medical school; others have looser arrangements.
"There are some things that are happening; it's not a total bust," said Anton Krucky, CEO of Tissue Genesis Inc., a regenerative medicine and cell therapy research firm founded in 2001 adjacent to the medical school.
The company recently began Food and Drug Administration clinical trials — a major step toward commercialization — for its stem cell therapy.
"We wanted to be by the medical school so they could claim they attracted a biotech company like Tissue Genesis even before their doors opened."
Some of the biotech companies in Hawaii working with the University of Hawaii medical school:
Skai Technologies has developed an artificial cornea, nanotechnology to monitor the authenticity of pharmaceutical pills and tablets, and materials to clean radiation and other toxic chemical exposures.
Tissue Genesis has developed vascular grafts lined with the patient's own vascular (endothelial) cells.
Hawaii Biotech focuses on the research and development of vaccines for established and emerging infectious diseases. The company has developed proprietary expertise in the production of recombinant proteins applicable to the development of safe and effective vaccines (e.g., for the West Nile and dengue fever viruses).
Cardax Pharmaceuticals is developing proprietary small-molecule therapies for largely unmet medical needs where oxidative stress and inflammation play important causative roles, including cardiovascular disease, hepatitis, macular degeneration and many cancers.
Cyanotech is a world leader in micro-algae technology and produces BioAstin Natural Astaxanthin and Hawaiian Spirulina Pacifica, all-natural, functional nutrients that promote health and well-being.
The Queen's Medical Center has two joint ventures related to biotechnology development. The first venture with the medical school addresses advanced technology for neuro-imaging. The joint venture has led to development of a methodology for correcting motion-induced artifact in magnetic resonance imaging scans. The second venture is with Hamamatsu Photonics in Japan. The joint venture has led to the development of a PET scan methodology for screening for early prostate cancer.
A lack of venture capital has been among the biggest challenges in creation of more biotech companies in Hawaii since it takes significant long-term investment and time to develop new products and services, he said.
"The investment economy is the lifeblood of entrepreneurial companies," Krucky said. "However, for biotech companies to flourish over a long period of time, interaction with an institution of higher learning is a key component."
The medical school has had difficulties fulfilling former Dean Edwin Cadman's dream of attracting sufficient world-class scientists to bring in major grants and contracts for research that, in turn, attract tech startups and businesses and create a thriving life sciences industry.
Some of that has happened, though not at the level or speed initially thought. The medical school has hired at least a dozen so-called gold-standard researchers out of a goal of 20. State budgetary restrictions have made it difficult to bring in more.
"With cutbacks in the state, we're not in the position to recruit additional faculty who would bring in more grants," said Jerris Hedges, dean of the medical school.
Progress has been slowed by a poor economy, limited investment by the state and a more competitive environment for a shrinking pie of federal grants, Hedges said. In addition, progress was significantly stalled when Cadman left the school in 2005 due to declining health.
"These things do not happen in a vacuum, and they do not happen overnight," Hedges said. "These activities evolve over decades and are catalyzed by collaboration and state investment in the academic infrastructure that generates the concepts and vehicle for business development."
The medical school, with an annual budget of $100 million, has made strides in building its research program and generated $48 million in grants and contracts in the past 12 months. However, it is far from its target of bringing in $81 million per year in grants and contracts, one of the promises Cadman made of the new medical campus.
On the private side of the vision, some biotechnology companies have made headway in developing technologies that could put Hawaii on the map for successful research and development of commercial products.
"We're on the cusp of a number of major developments for companies that are here in Hawaii that are a direct result of that vision," said David Watumull, chief executive officer and president of Cardax Pharmaceuticals Inc., a spinoff of Hawaii Biotech Inc.
"With more time I think we will see growth in this industry in Hawaii that could surprise people. The types of financial results that occur in this industry could be large enough to have statewide impact."
Groundbreaking for the UH Cancer Center late last year is fueling momentum and renewed hope that the Kakaako campus can become a catalyst for a more robust diversified economy.
Landowner Kamehameha Schools continues to evaluate the feasibility of a proposed $200 million Asia-Pacific Innovation Center adjacent to the medical school, initially envisioned to provide substantial research space, including wet labs that would be available to bioscience-related enterprises.
"Kamehameha Schools remains supportive of a life sciences ‘cluster' in Kakaako makai, and we are encouraged by the construction of the University of Hawaii Cancer Research Center," said Paul Quintiliani, director of Kamehameha's commercial real estate division.
"The cost of building laboratory and supporting office space is considerably higher than typical office projects, and so our biggest challenge has been finding viable tenants with funding to support the project."
A first step in redeveloping Kakaako, Kamehameha is moving forward on a master-planned urban neighborhood with the first phase of apartments scheduled to open by the end of 2012. Kamehameha's vision for the project is to support scientists and other workers at a life sciences campus.
"We have some great science, we have some great people and we're short on capital," said Barry Weinman, a major contributor to the UH med school and founder of Allegis Capital, a Silicon Valley venture capital fund that manages $700 million. "We've made a small number of steps, but we have not accomplished the goal. However, the goal is still living. It's just been delayed."
Fujifilm Diosynth Biotechnologies is to add a 1,000l Xcellerex® single-use bioreactor to its RTP, North Carolina facility, in order to expand its existing contract manufacturing capabilities. This expansion reinforces the commitment to lead the global biologics CMO industry through continuous innovation and implementation of new technologies, service delivery and quality, as announced by Japan-based parent company, FUJIFILM Corporation.
The addition of the 1,000l single-use bioreactor and mixers with single-use harvest filtration will supplement existing seed train and purification equipment as part of a hybrid implementation approach. This project is the continuation of an on-going cell culture capacity expansion by Fujifilm Diosynth Biotechnologies. This addition complements the 200l Xcellerex single-use bioreactor already in operation at the company's process development laboratories in Cary, NC, and the existing 2,000l stainless-steel train located in the RTP, NC cGMP manufacturing plant.
"Single-use technologies are uniquely suited for multi-product contract manufacturing with the added advantage that the operations are easily transferable between sites and are easily expandable for increased supply needs," said Stephen Spearman, president of Fujifilm Diosynth Biotechnologies USA.
The XDR-1000 can be operated at working volumes ranging from 200l-1,000l. "The flexibility of scale will allow us to better serve the demands of companies requiring material for pre-clinical studies, early to mid-phase clinical production and beyond," added John Foy, senior director of business development and logistics at Fujifilm Diosynth RTP.
The expansion is anticipated to be validated and fully operational by Q1/2012.
One of the world’s leading biopharmaceutical companies, Shire Human Genetic Therapies (HGT) focuses their work on life-shortening, neuro-muscular conditions such as Fabry disease, Gaucher disease and Hunter syndrome. These diseases are treated by enzyme replacement therapies that are now being produced in one of the company’s newest and most unique facilities.
Project Atlas, in Lexington, MA is Shire’s third cell culture facility and one of four buildings on the Lexington Technology Park (LTP) campus – the global center for Shire’s HGT division. The Atlas facility supports the manufacture of Replagal® (for Fabry disease) and VPRIV® (for type 1 Gaucher disease).
While a number of features make Project Atlas stand out, perhaps the most intriguing is Shire’s first-ever implementation of extensive single-use technologies at commercial scale. And at the heart of this ambitious project are a number of unique and customized processing solutions that were developed during design and construction.
In its 200,000 square feet of production space, Atlas provides multi-product upstream and downstream operations for two simultaneous production runs. This is complimented by three completely sterile trains; two 2,000 L and one 500 L perfusion cell culture bioreactors, with the 500 L reactor capable of being upgraded to a 2,000 L reactor without layout modifications or utility upgrades.
With speed to market as the primary driver in combating such vicious diseases, Shire researched and analyzed the use of single-use technology versus stainless steel. The main challenge was that single-use process technology had yet to be proven at the 2,000 L scale. However, CRB, the project’s design and engineering firm, helped discover a number of benefits that fortified the company’s decision to make Atlas a single-use facility:
• Single-use led to a significantly shorter construction time.
• The disposable nature of the system meant nearly all CIP and SIP considerations were eliminated, cutting additional costs and saving time.
• Aseptic bags, a closed process, and single use bioreactors and tubing help reduce the potential for contamination.
• Production schedules can be compressed since there is no need to clean vessels. The savings realized by reducing the number of media and harvest hold vessels was approximately $350,000 per bioreactor, and since no vessel would ever be out of use for cleaning, Shire was able to eliminate three 3,000 L vessels per bioreactor, saving roughly $1 million.
• Also, although it is counterintuitive to believe that technology utilizing single-use plastic bags is better for the environment, it proved to offer some very green benefits:
• The use of caustic cleaning materials is decreased by 95 percent.
• Bags can be reused at certain points along the sterile train, such as in media hold.
• 87 percent less water is consumed.
• Facility footprint was shrunk by 38 percent.
• Single-use translates to 30 percent less energy being needed for process equipment and 29 percent less energy for HVAC.
• 25.5 percent less CO2 is emitted.
Additional benefits for Shire in implementing this approach included:
• Improved safety, in the event of instrument malfunction, the operator can see what’s going on and react more quickly.
• Culturing new products is made easier by the uniformity of instrument connectivity and interface. Single-use equipment will always be the same in all facets of production. To take a product from the lab to clinical or from clinical to commercial, one need only define a small number of scaling parameters.
• Flexible, single-use tubing allows for piping modifications that would be more difficult with stainless steel.
• An operator can change out one bioreactor bag or centrifugal insert more quickly than it would take to clean stainless steel piping and vessels. So Atlas can switch production focus in a couple of shifts, rather than days or weeks.
• Due to the closed nature of the technology, cleanroom space is optimized by moving some systems out of classified space and into controlled non-classified space. This cuts costs while improving maintenance access.
When asked about lessons learned in implementing a single-use approach, Jerry Justin, Shire Plant Manager offered the following advice:
• "Fluid mixing and temperature control are important considerations as the scale of the operation increases.
• "Be open to working with vendors in seeing what type(s) of new technology is available or been successful.
• "Understand the impact that leachables and extractables will have on your process.
• "While initial capital costs may be lower with disposables, also pay attention to how on-going operating costs may be more expensive."
During facility design, no single-use 2,000 L bioreactors were in use anywhere in the world because of the difficulties with agitation in a bag so large. Shire’s design team worked with Xcellerex to design a system that would provide mixing at the top and sides of the bag without creating shear around the impeller. The solution was a single-use, bottom-mounted, magnetic impeller pre-packaged with the 2,000 L bio-bags and driven by an external motor.
Another significant equipment innovation was the highly integrated control system spearheaded by Honeywell. The single-use bioreactors were packaged with their own control software for consistency and ease of use, but Shire felt it important to have a uniform interface across all their skids. A unique element on the Shire project was the construction of a full, mock working system that was built by Xcellerex and supported by Honeywell in working out any issues of the single-use system in advance of the actual implementation.
Custom designing the software would permit Shire to control the centrifuge and bioreactor as a single unit. This came at significant cost - approximately $750,000, but according to the company, the result was a uniform interface that will reduce errors and training time, while permitting seamless data integration and collection.
The automation control system also executes batches in a controller, rather than a server-batch application. This eliminates extra hardware costs and time spent on infrastructure development by reducing the number of components required to implement the automation. Additional benefits include:
• Functionality can be better distributed between the batch procedural levels, so there’s a series of standalone subsystems that can run for several weeks without intervention.
• The user does not have to take the entire batch management system out of service to make configuration changes—only the affected areas.
• Fewer communication points that could be connected by mobile laptops outside washdown areas, which use a wireless mesh network, simplified the overall automation system.
Additional equipment-based production benefits realized from the implementation of the single-use system included:
• A disposable tangential flow filtration (TFF) system was selected for easing scalability and changeover between multiple batch sizes.
• A risk-based assessment led to the determination that a purified water system had no direct impact on product quality. So Shire switched control of the purified water to a less demanding system that is faster and less expensive to operate.
• 162 limit switches were eliminated after the design team determined they were not necessary on GMP (good manufacturing practices) utility valves, saving Shire another $350,000.
A final component of Shire’s strategy was based upon the concept of “briefly exposed.” For example, the media and buffer preparation operations are open processes that require powder additions. Since the process is open, the room environment is typically classified and the solution is filtered. The Atlas facility locates the preparation vessels in classified space, but considers the process closed as the material is delivered to the transfer panel. At the transfer panel, a connection is made between the media hold bag and the transfer panel that is “briefly exposed” (i.e. the clean outlet port of the valve is exposed briefly to the room environment in order to make the connection). Assessment led to declassifying the entire media and harvest hold room. The team was able to declassify over 7,000 square feet, saving time and money.
While no one element can be given all the credit, the portions of the design and engineering plan detailed here all played a crucial role in the successful completion of the Atlas project. In addition to getting life-saving medication to their customers more quickly, Atlas opened five months ahead of schedule and $10 million under budget. While single-use may not be the best approach for every facility, Shire credits it with taking the Atlas project to greater level of success.
Harvard has revamped its proposal for a new science campus in Allston to include an "enterprise research campus" with as many as 12 buildings for pharmaceutical, biotechnology, and venture capital companies, alongside the planned 700,000 square feet of space for labs and academic researchers. The addition of space for industry partners indicates Harvard is moving more toward encouraging partnerships between commerce and academia, to effectively compete with MIT's new integrative cancer research institute. Harvard is still working out which researchers will be moved to the new campus.
A multinational firm has purchased a Eugene, OR biotech company for $6 million and plans to expand its operations at the Riverfront Research Park.
MitoSciences, a spinoff from University of Oregon research, has been acquired by Abcam PLC, which has its headquarters in Cambridge, England. The deal gives MitoSciences access to the larger company’s huge catalog of raw materials for biological research and drug development.
Perhaps more importantly, it also allows MitoSciences to benefit from Abcam’s significant marketing program, which frees the Eugene firm to concentrate on research and manufacturing. John Audette, general manager of MitoSciences, said the deal will allow the company to grow more quickly than it could have done on its own.
“It’s a great thing for the Eugene business community,” he said. “We’ll just be able to grow faster than we’d be able to do under our own steam.”
MitoSciences currently employs 23 people at its Eugene office and is looking to quickly hire two more. More hiring may come, and Abcam may move some existing employees to Eugene, Audette said.
Also, the company plans to expand its footprint in the Riverfront Research Park by more than 5,000 square feet. The space will be used for research and development and manufacturing.
MitoSciences is a leading provider of high-quality biological products known as monoclonal antibodies, which are used in a variety of disease research and drug development programs. It grew out of research done by University of Oregon professors Roderick Capaldi and Mike Marusich, who founded the company.
Abcam offers a catalog of antibodies and other products used in bioscience research and testing. It has offices in the United Kingdom, the United States, Japan and Hong Kong.
Audette said MitoSciences had been looking for a partner to allow it to continue its strong growth. The greatest need was in marketing since MitoSciences had been reinvesting all of its profits in research and development.
Abcam will take over the marketing operation, allowing MitoSciences to concentrate on its core products, Audette said. MitoSciences will keep its name and will sell its products through Abcam’s website and distributors.
“This means we’re just going to be able to do the same very innovative work we’ve always done,” Audette said. “We can just do more of everything.”
Abcam had a profit of $31.5 million on sales of $116.6 million from its continuing operations in its last fiscal year, which ended June 30, 2010.
“We are delighted to have this opportunity to extend our product offering to customers and strengthen our business in this research area,” Abcam chief executive Jonathan Milner said in a statement announcing the acquisition.
UO vice president Rich Linton said, “MitoSciences’s success story is exactly what the University of Oregon’s technology transfer efforts are all about: An idea born in research is turned into commercial applications that benefit Oregon’s economy, and, in this case, goes on to benefit health-related pursuits around the world.”
University officials said that MitoSciences is part of a growing number of Oregon-based companies that have close ties to UO research. Together, these 17 businesses employed 255 Oregonians and generated $32.9 million in revenue last year, according to the UO.
HWI Global, a cleanroom design engineering and construction services providing company, declared that it has started the building of an ISO 7 cleanroom measuring around 10,000 ft2 for Powerex. The new cleanroom will be added to the 90,000 ft2 production facility and corporate offices building of Powerex.
HWI Global has commenced the initial design and engineering for the new construction in the fall of 2010. It performed a complete evaluation of the tenant improvements in the present building before earmarking the clean production space. The general construction division of the company had started its work in December 2010 and has provided a range of services such as demolition of total mechanical and electrical setup, repositioning of a 200-ton chiller, erection of a main gas line for a distance of 1,300 linear-feet, and completed the upgrades for plumbing and fire extinguishing systems. The company has also relocated the equipment of the present IPP Integrated Power Product production and Stem Cell low level production cell locations of Powerex.
The new cleanroom is anticipated to be certified by the middle of September and will be ready with the equipment for operations from the beginning of October this year.
Governor Robert Bentley was on hand to acknowledge the state's ongoing dedication to the HudsonAlpha Institute for Biotechnology and expansion of the life sciences industry in Alabama.
"The addition of a new facility on the Cummings Research Park Biotech Campus creates opportunities to significantly enrich the state's knowledge worker economy," said Bentley.
Bentley will join HudsonAlpha co-founder Jim Hudson to announce construction of a third building on the campus.
According to Hudson, the institute facility, housing both non-profit researchers and for-profit businesses, is full.
"We have some tenants who would like to have additional space. With the third building coming online, there is another option for them, as well as space to accommodate new organizations to the campus through the state's economic development office," said Hudson.
"Building three, adjacent to the HudsonAlpha Institute for Biotechnology, fits well with Alabama's long term economic development plan to attract, build and retain a vibrant life sciences industry that will enhance quality of life for citizens both inside and outside of Alabama," said Bentley. "I am excited to be in Huntsville to break ground on another building in this impressive complex."
The state has committed $10 million to fund the campus expansion.
According to Dr. Rick Myers, president of HudsonAlpha, the institute's high throughput genomics and genetics infrastructure is a draw for a variety of research and development companies addressing testing, disease diagnostics and therapeutics, as well as organizations focusing on other biomedical devices and services.
"These exciting new technologies are also attractive to organizations with goals to create sustainable fuels, conduct environmental remediation and enhance agricultural yields," he added.
Site preparation work began in March. HudsonAlpha officials anticipate building completion by year's end, providing an additional 88,000 square ft. of lab and office space on the campus. The facility will be LEED-certified.
"Embracing metrics to ensure green building design, construction and maintenance is a matter of both conscience and practicality as we go forward," said Hudson
The non-profit HudsonAlpha Institute was first announced in 2005. The second building on the campus, the Jackson Center, opened in August of 2009.
HWI Global, Inc., the Pittsburgh-based cleanroom design builder, reports commencing construction of a Class 10,000 Life Science cleanroom at Walter Reed Army Institute of Research in Silver Springs, MD, under the direction of the United States Army Corps of Engineers.
The project includes four separate cleanroom work zones within the designated space. An ISO 7 clean work room will house two biosafety cabinets and two incubators, as well as an ISO 8 centrifuge cleanroom.
HWI will install its Bio-Gard Modular Wall System; an aseptic, high-impact, Class 1/A bio-pharmaceutical wall system with heat-welded seams; and the complete air handling and control system. HWI Global was chosen for this project by FLAD Architects, and Affiliated Engineers, both life science specialists located in Gainesville FL. HWI Global has entered into a subcontract with Rockville, MD-based general contractor John J. Kirlin for the Walter Reed assignment.
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced a $38 million expansion of its Grand Island, New York manufacturing facility.
APP's investment includes enlarging the manufacturing site by 13,000 square feet and adding an additional six production lines for injectable products. Expansion measures are anticipated to last two years, with work on the site beginning in June 2011. Currently, 580 people work at the Grand Island site and APP plans to hire an additional 90 employees within the scope of the site expansion.
As a leading supplier of injectable pharmaceutical products in North America, APP offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics. At its Grand Island facility, the company manufactures a variety of injectable pharmaceutical products for the North America market that encompasses four therapeutic areas: anti-infectives, critical care, analgesia/anesthesia and oncology. The expansion will increase APP's manufacturing capabilities of injectable generics, enabling the company to make a significant contribution to meeting the steadily growing market demand for these products in the future.
"The Grand Island facility has a longstanding expertise in the production of injectable generics," said Frank Harmon, Executive Vice President and Chief Operating Officer at APP Pharmaceuticals. "The expansion of Grand Island demonstrates our commitment to Erie County and the State of New York to remain an active employer in the region." In addition, the company announced that Empire State Development will provide $1,187,763 in Excelsior Jobs Program tax credits over a five year period, while the New York Power Authority will assist with an allocation of 2,000 kW to bring the company's power costs in line with other out-of-state locations. Erie County Economic Development Corporation will provide property tax, sales tax and mortgage tax abatements.
"APP Pharmaceuticals will create good, quality jobs that will help expand the important life sciences sector of our economy and help Western New York continue its revitalization," said Empire State Development President, CEO & Commissioner Kenneth Adams. "We're pleased that Empire State Development could be a part of APP's decision to remain in Grand Island." Dr. Michael Schonhofen, President, Science, Production & Technology, Fresenius Kabi added, "The Grand Island facility forms part of a global supply chain network that provides pharmaceutical products to the U.S. and Canada. The investment in this facility is an important step within our production strategy. Through the expansion, the site will significantly contribute to the continuous local supply of high quality injectable generics for the U.S. and Canada."
Built in 1970, APP's Grand Island plant obtained FDA certification that same year. The facility has been expanded a number of times, most recently in 2005 when the company enhanced the site's manufacturing capability for aseptic filling and packaging, as well as for the production of oncology drugs.
Nypro Inc. is expanding its pharmaceutical packaging and health-care plant in Mebane, NC, and adding a medical device development and design center at its headquarters in Clinton, MA.
Construction on the 90,000 square foot expansion in Mebane will begin in the next 90 days, and the new portion of the plant will be operating by June 1, 2012, said Ray Grupinksi, group president of Nypro Healthcare. The expansion includes a 40,000 square foot clean room.
“The expansion is largely for our pharmaceutical packaging business,” Grupinksi said. “Our opportunities there have been growing.” Currently, about half of the Mebane plant is used for pharmaceutical packaging, and the other half is used to make health-care devices and components.
Grupinski said the design center in Clinton, scheduled to open in February, will use existing space and be similar in size to its current design center in Dublin, Ireland.
In addition, he said Nypro is building a new design innovation center in Ireland that will open Jan 1. replacing the existing center.
“This will enhance our ability to win more business because development is so integrated with design,” Grupinksi said. “OEMs aren’t just outsourcing their manufacturing. They are now outsourcing parts of their research and development work, but retaining oversight” of those projects.
He said the center in Clinton will enable Nypro to use its engineering, automation and tooling expertise to reduce production development and manufacturing costs.
“When you develop the device from the ground up, you improve speed to market, you get improved manufacturability and you get reduced cost,” he said.
“”We’re very bullish and expect to grow in the double-digits in 2011,” said Grupinski. Nypro is gaining market share in the medical sector because of three trends: the continued shift to outsourcing, the drive by OEMs to consolidate their global supplier footprint and the desire by OEMs to have suppliers with a presence in the three key regions worldwide, North America, Europe and Asia.
“Every one of our customers compete in two of those three regions and wants to get into the other,” Grupinski said. “And they are looking to reduce their number of suppliers to two, maybe three. They want one stop-shopping where they can get everything from design to end product handling and they want customers with geographic reach. We have the ability to manage projects for them from concept to product development.”
He also said OEMs are increasingly looking to their top suppliers for innovation and partnerships, and to help them cut costs.
“There is a lot more pressure on our customers to reduce costs, so our customers are much more open than ever to design modifications to take costs out of product,” Grupinski said. “A lot of customers are looking to our lean six sigma team to help them take costs out.
The latest expansions in the medical market come on top of other expansion efforts by Nypro in that market in the past year.
A 75,000 square foot expansion at Nypro’s Asheville, N.C., health-care plant which makes injectable insulin pens is near completion. That project will double the plant’s cleanroom space.
And, in January, Nypro completed its acquisition of Schlosser Medizintechnik GmbH of Knittlingen, Germany, and a supplier of medical plastic parts for diagnostic devices. Schlosser has a 169,000-square-foot factory with Class 7 and Class 8 cleanrooms.
In addition, Nypro began using solar and wind power at its Mebane plant last month as part of an initiative to use more renewable energy and reduce its greenhouse gas emissions.
Nypro spent than $1 million to cover the building’s 113,000 square feet roof with solar panels and to build a wind farm with four wind turbines. The energy generated by the system will be provided to the local electric company and will, in turn, offset the cost of providing energy to at least six electric injection molding presses in the 200-ton range.
The Mebane project is part of a corporate initiative to have all of its packaging plants some day run on renewable energy sources.
Nypro had $1.3 billion sales in fiscal year 2010, which ended June 30, 2010, with healthcare accounting for 30 percent of the company’s revenues. That was a 14 percent increase over fiscal 2009.
In addition its profit in fiscal 2010 before ESOP cost and taxes was $46.4 million, up 84 percent from 2009 and its EBITDA (earnings before interest, taxes, depreciation and amortization) set a record high of $114 million.
In fiscal 2010, Nypro also reduced its net debt by $47 million to its lowest level since 2003, and, achieved an 11.1 percent return on assets, its highest level since 2002. Its net income was nearly $30 million, with $19.3 million attributable to Nypro Inc. compared to $6.8 million and $2.6 million, respectively, in fiscal 2009.
A Spanish company that manufactures animal vaccines plans to build its first U.S. plant in Ames, Iowa.
David Nogareda, president of Amer, Spain-based Laboratorias Hipra, says Ames is a great location because of its proximity to Iowa State University. The facility would be at the university's research park.
The Ames Tribune reports construction is expected to begin by year's end. The plant would be in operation by 2014 and employ 60 workers.
The project still needs approval from state and local authorities.
BioMarin Pharmaceutical is a biotechnology firm headquartered in Novato, California. The company's operations in Novato span approximately 500,000ft² comprising eight buildings that are located within a half mile radius, in the Bel Marin Keys Business Park. The buildings include laboratories, offices and manufacturing areas.
The Galli facility is BioMarin's only manufacturing unit dedicated to the commercial production of Aldurazyme (laronidase) and Naglazyme (galsulfase) along with two clinical products. The facility was built in 1999 and began operations in January 2000 after obtaining licensure from the US FDA and the European Commission. It has since undergone a series of expansions, the last being completed in 2010.
A $60m expansion (including $40m in construction and $20m in equipment and validation) to the facility was carried out to double the commercial production capacity. This expansion, called Galli East, provides BioMarin with the required capabilities to manufacture two marketed products along with several potential treatments that are currently in late stage clinical testing.
The expanded facility is currently undergoing process qualification and is scheduled to receive FDA approval in late 2011 or early 2012.
The Galli drive facility spans 80,000ft². It houses process manufacturing areas, quality control laboratories, materials, warehouse, and utilities support areas and dedicated zones for manufacturing-related administrative activities.
The manufacturing facility is equipped with mammalian cell culture and protein purification capabilities. It includes Class 100,000 and Class 10,000 cleanrooms with HEPA filters that change air up to 45 times in an hour. The HEPA provides 40 times cleaner air than normal office air.
During the expansion, a 24,000ft² three-storey facility was added to the Galli Drive facility. Space for the new facility was created by removing a section of the high bay warehouse. The new facility is equipped with multiple large process tanks with access platforms and stacked bins for storage of buffer and media preparation, a high-bay cell culture space meant for future scale-up, a glasswash suite, several cold storage rooms and suites for filtration, purification and formulation. The new roof features HVAC systems that support the classified clean areas.
In addition, the Galli drive facility was renovated to include new gowning rooms, service zones and a Hazardous-occupancy space for clean-in-place (CIP) and waste neutralisation systems. A new utility yard was installed for bulk chemical storage, electrical upgrades, waste storage and fire protection enhancements.
The facility manufactures Aldurazyme and Nagalazyme, which are enzyme replacement therapies (ERT) respectively for mucopolysaccharidosis I (MPS I) and mucopolysaccharidosis VI (MPS VI) treatment. It also manufactures two clinical products, GALNS to treat mucopolysaccharidosis IV (MPS IV) and PEG-PAL to treat Phenylketonuria (PKU).
The technology used at the facility is based on continuous perfusion of Chinese Hamster Ovary (CHO) cell culture that has been genetically modified to produce human enzymes. The technology allows the continual production, isolation and purification of the desired enzyme using perfusion based technology.
Genetically modified host cells are stored frozen until needed for production. The host cells thawed are then added aseptically to a flask containing the appropriate growth medium. As the cells grow and divide, they are transferred to larger flasks to allow additional cell growth. The process is repeated until sufficient volume is reached at a specific cell density for cell culture inoculation into a production scale bioreactor.
The cells grow and multiply rapidly in the bioreactors. The growth is supported by stirring the cells continuously and adding air and specific nutrients. The desired enzyme gets secreted as the cells mature. During purification, the cell culture fluid flows sequentially through several chromatography columns. The columns use different modes of selectivity to remove the impurities and separate the desired enzyme from the growth medium and other proteins.
The enzyme is formulated into a solution during the Ultra Filtration / Diafiltration (UF/DF) process using formulation buffer. The UF/DF brings the product and the excipients to the required concentrations.
The expansion was carried out without disrupting commercial and clinical production in the neighboring facilities. The building was constructed from the inside out, which allowed for work to continue throughout the winter. The support piers were drilled inside the existing building before demolishing the shell.
The construction contract for the project was awarded to Dome Construction. The architect to the project was VDK Architects and the project engineer was bioKINETICS.
Pharmaceutical giant Pfizer Inc. announced a partnership with leading Boston-area hospitals, medical schools, and universities -- in a novel attempt to address a major hurdle in medicine: the years-long gap between basic science advances and the testing of drugs in patients.
Under the unusual arrangement, the company will invest $100 million over five years and establish a research space in the heart of the Longwood Medical Area where Pfizer scientists will work in close proximity and team up with academic scientists. The new Center for Therapeutic Innovation, which will create about 50 new jobs, is part of a global Pfizer initiative to foster new kinds of collaboration with academia to accelerate drug development, a program that will be headquartered in Boston.
The office, in Menlo Park, will provide drugmakers in the region with everything from discovery and development to active pharmaceutical ingredient manufacturing (API) services.
Senn's director of project management and client services, Elizabeth Hoffner, predicted that the new office will be important in generating new business for the contract manufacturing organization (CM).
"We expect our new location, interspersed with many dynamic young companies, and established research institutions including the Stanford and University of California campuses, will allow us to better identify the projects and companies where our expertise can help bring a new compound, therapy or diagnostic method to market more quickly and efficiently."
Ximedica, a full-service medical device product development firm based in Providence, R.I., has opened a regional office at the University Enterprise Laboratories (UEL) Center in Minneapolis, Minn.
The new location marks the company’s third facility and will serve as a central hub for its healthcare client base in the Midwest, company officials said. The firm also has an office in Hong Kong, China, to support its Asia supply-chain operations.
“Ximedica has always been a trusted partner to its clients,” said Stephen Lane, CEO and co-founder of Ximedica. “We have earned this by collaborating with them to deliver sophisticated medical devices built for today’s healthcare environment. By joining our clients in Minnesota—a community rich with medical device companies, leading academic research and clinical institutions—we are able to build upon this trust and grow together.”
Staff for the new location will include such specialties as industrial design, human factors and engineering.
David Copeland, director of Human Factors Industrial Design at Ximedica, will lead the new Minneapolis location.
The Minnesota facility is expected to be at full capacity this fall. As part of the company's expansion and regionalization strategy, it also is expanding its Providence location to 100,000 square feet of integrated product development space.
HYCOR Biomedical, Inc., a manufacturer of diagnostic products for clinical laboratories, announced plans to relocate its headquarters from Garden Grove, Calif. to Central Indiana, adding 12 jobs by the end of the year and up to 20 jobs by 2013.
This is the second California company to relocate its headquarters to Indiana in the past two years. In 2009, Fleetwood RV moved from Riverside, Calif. to Decatur, Ind., creating 300 new jobs. Additional companies including Beckman Coulter have consolidated operations from California in recent years.
“During tough economic times, Indiana welcomed new jobs from companies consolidating from a couple dozen or more U.S. states and a handful of foreign countries. HYCOR is the latest example of the benefits of maintaining fiscal discipline and a low-cost business environment,” said Mitch Roob, Secretary of Commerce and chief executive officer of the Indiana Economic Development Corporation.
HYCOR entered the diagnostics market in 1984 and currently provides urinalysis, allergy and
autoimmune testing products for clinical laboratories, hospitals and doctors’ offices worldwide.
“Given Indiana’s central location, the exceptional life sciences talent based here, as well as the economic incentives being offered by the state, we believe this is the ideal time for HYCOR to relocate as our business continues to grow,” said Richard Aderman, president and chief executive officer of HYCOR.
The Indiana Economic Development Corporation offered HYCOR up to $640,000 in performance-based tax credits based on the company's job creation plans. HYCOR is currently leasing space at 3021 East 98th St. in Indianapolis while it finalizes a long-term location in Central Indiana in the coming months. HYCOR is the second life sciences company to move into Central Indiana in just more than one month.
In March, Advion BioServices Inc. announced plans to establish a $6.1 million laboratory at the Purdue Research Park at Ameriplex, adding 49 immediate jobs and up to 66 jobs by 2015.
Florida-based contract manufacturing organization (CMO), Goodwin Biotechnology (GBI), has entered into an agreement with protein and monoclonal antibody drug developer, Rafagen, to provide cell line engineering and biological contract manufacturing services.
Part of the India-based Wallace Group, GBI specializes in manufacturing monoclonal antibodies, recombinant proteins, and vaccines. According to Rafagen co-founder, president, and CEO, Sung Ho Hahm, this makes it a perfect partner for the Maryland-based company as they join forces to expedite the development of superior recombinant proteins and peptides.
“We seek to address unmet needs of patients with inherited and acquired diseases,” said Hahm.
“With Rafagen’s proprietary technology platforms, the highest producing cell lines will be established at a fraction of the time currently required. This translates the promise of science into tangible therapies that restore health and save lives.”
Soo Young Lee, senior vice president at GBI, said he believed the two companies had a great deal to offer one another, and potential clients.
“By collaborating with Rafagen for cell line engineering, we at GBI can expand our capabilities as a biological contract manufacturing organization and offer one-stop shopping,” he said.
“This enables our clients to overcome challenging projects by working from their cDNA to develop more robust and high productivity cell lines that will not only scale up with greater efficiency, but by identifying cell lines with the highest level of efficacy, the end product will hopefully optimize patient outcomes.”
Rafagen claims its proprietary technology designed to “solve the most challenging problems in molecular therapeutics” can encourage a marked increase in drug production from manufacturing facilities, helping launch drugs more quickly, and consequently generating revenue at a faster rate.
The company has strong ties to South Korea, having recently signed a memorandum of understanding with the governor of Chungcheongbuk-Do province stating its goal to build bio-manufacturing plants in the region.
Meanwhile GBI has nearly 20 years of experience as an independent CMO, and offers fully integrated current good manufacturing practice (cGMP) services, with particular expertise in the development and manufacture of recombinant proteins and antibody drug conjugates.
The Jackson Laboratory has decided to pull the plug on its plan to expand into Florida, citing a lack of available funding from the state.
In an announcement made, the Bar Harbor, Maine-based biomedical research institution said its decision was based on Florida's "severely constrained state budget," which precluded Jackson Lab from getting the $100 million in state funding that it was seeking in order to create a facility in Sarasota County.
Charles Hewett, executive vice president of Jackson Lab, said that despite support from state economic development officials, the funds needed to expand into Florida just weren't there. "We were invited to submit a much-reduced proposal to the Florida Innovation Fund, but the amount available in that fund now, and the uncertainty of future funding, made such a venture too speculative to undertake responsibly," he said.
Hewett also said that Jackson Lab will no longer pursue a plan to create a facility in Florida. "We understand Florida's budget situation, and we will turn our attention to other priorities," he said.
The laboratory, which also has a facility in Sacramento, Calif., had been eyeing Florida for its third site since October 2009, and initially planned on building a facility in Naples to house its personalized medicine partnership with the University of South Florida. Jackson Lab projected that by 2020 its Florida facility would have 244 employees. A consultant's report added that by 2020 the facility would generate a total of 4,913 jobs, and by 2032 it would generate 11,490 jobs.
The proposal originally had the support of state lawmakers, including then-Gov. Charlie Crist, who were ready to provide $130 million in state funding for the proposed facility. Gradually, though, questions about the project's economic viability were raised. After lawsuits were filed in connection to $50 million in Collier County funding that would have been part of the state's $130 million contribution, Jackson Lab began exploring other locations in Florida.
This past March, it announced plans to locate its facility in Sarasota. The personalized medicine institute would have resided in a 120,000 square-foot facility and included labs and offices in the USF Health complex in Tampa. The focus of the institute was to have been on developing genetics-based treatments for heart disease, Alzheimer's disease, and diabetes.
The University of Florida has broken ground on construction of a 120,000-square-foot institute that will house research into aging and clinical and translational studies, including genomics and bioinformatics.
The bi-winged Clinical and Translational Research Building (CTRB) will include a 40,000-square-foot wing that will be the new home of UF's Institute on Aging, and 80,000 square feet will be dedicated to a Clinical and Translational Science Institute (CTSI) and other research programs, conference, training, and reception areas.
The new building was funded with $45 million, including a $15 million grant from the National Institutes of Health under the American Recovery and Reinvestment Act for the Institute on Aging wing, and $30 million from the University to pay for the CTSI and the building's other features.
"The CTRB will be the home of patient-centered innovation and discoveries that help secure a healthy future for the citizens of Florida and the nation," David Guzick, senior vice president for health affairs and president of the UF & Shands Health System, said in a statement.
"One of our most important jobs as a major research institution is to streamline the process of getting medical discoveries from the lab to the hospital or doctor's office," added UF President Bernie Machen. "That's just what this building is designed to do, and at the same time it will help further advance UF's position as a national leader in research and in patient care."
The Institute on Aging's resources include the Genomics and Biomarkers Core, which will provide the infrastructure, lab space, personnel, and technologies to support 'omics-based research at the institute. These resources include tools for conducting research including genome-wide and gene expression analysis, microarray-based studies, mass spectrometry, quantitative PCR, and other approaches.
The Clinical Research Core is a resource for conducting randomized controlled trials and observational studies.
The Clinical and Translational Sciences Institute that will reside in the new building will be a multidisciplinary facility with several departments that will pursue advanced research into aging, cancer, cardiovascular disease, diabetes, and other aging-related illnesses.
The CTSI is funded with a five-year, $26 million grant from the NIH's Clinical and Translational Science Award program, and by additional commitments totaling $93 million from the UF College of Medicine and the Office of Research.
The CTSI also will include departments that will focus on biomedical informatics, biostatistics, aging and geriatric research, and epidemiology.
Tasly Group, a biopharmaceutical company based in China, said Thursday it will invest $40 million to take up 430,000 square feet in Montgomery County.
The company will open a production facility and training center for traditional Chinese medicine in the Shady Grove Life Sciences Center. It is the largest investment in Maryland by a Chinese company, according to Gov. Martin O’Malley’s office, and is slated to bring “dozens of jobs” to the state over the next three years.
O’Malley made the announcement following a keynote address on his first full day of a 10-day economic development mission to Asia. Sixty-eight business leaders, politicians and higher education officials have joined O'Malley on the trip.
“By reaching across borders, we can share knowledge and research, generate promising partnerships, and leverage the power of innovation to create jobs and expand opportunity to make our children winners in this changing, global economy,” O’Malley said in a statement.
Tasly is preparing for phase III clinical trials of their Compound Danshen Dripping Pills (CDDP), traditional Chinese medicine developed to treat and prevent coronary disease. The company plans to collaborate with Johns Hopkins University and the other biotech companies located at Shady Grove.
The company’s chairman Dr. Yan Xijun said he was looking for the most talent-rich place to introduce his company to the U.S.
“Maryland, with its rich scientific community and world-class universities is the perfect fit for us,” Yan said.
A release said Tasly’s long-term goals include making CDDP the first traditional Chinese medicine product to launch as a Food and Drug Administration-approved pharmaceutical in the American market. The company hopes CDDP could be on the shelves as early as 2014 if its phase III trials are successful.
O'Malley also announced that two emerging Chinese companies — Sunscape, a producer and supplier of new building materials and CellPath China, a life sciences company – said they plan to set up U.S. operations in Maryland’s International Incubator. Additionally, DaSol Energy Science and Technology Co., a Chinese solar energy company, will renew its contract with the Incubator.
There are 13 Chinese headquartered companies with offices in Maryland, including Yisheng U.S. Biopharma, another biopharmaceutical company located in Montgomery County.
Construction and hiring are under way for the facility in the Research Triangle Park where Medicago U.S.A. is planning to produce influenza vaccines using tobacco leaves.
Michael Wanner, vice president of U.S. operations for the Canada-based
clinical-stage biotechnology company Medicago Inc., said 16 employees have been
hired so far for the new facility that's expected to come online in September.
The company has plans to hire a total of 85 employees, and Wanner said
approximately 70 are expected to be hired this year.
Wanner said the impetus for the $42 million project was a partnership with a
government agency that's behind an initiative launched in 2009 to develop a
response to a potential pandemic influenza or man-made outbreak.
The Defense Advanced Research Projects Agency, a unit of the U.S. Department of
Defense, gave a $21 million grant so the company could demonstrate how its
plant-expressed, virus like particle vaccines could be manufactured on a large
scale.
Medicago also put in $7.5 million of the total project cost, and Alexandria Real
Estate Equities Inc., the owner of the new building, put in $13.5 million.
Medicago Inc. is a clinical-stage company, which means it doesn't have any
vaccine products on the market yet.
It is in clinical trials for vaccines that use virus like particles to boost
immune response. Wanner said the particles resemble viruses, but do not contain
any genetic material of the virus. Mammals' immune systems recognize the
particles as viruses because of the particles' cell surface proteins, he said,
which cause an immune response and makes them a useful tool in vaccine
development.
Wanner said the agency was interested in rapid vaccine development.
The Defense Advanced Research Projects Agency launched an effort in 2009 to
identify research that could help in a potential government wide response to the
novel influenza virus H1N1. Part of that initiative included the Accelerated
Manufacture of Pharmaceuticals program that is an effort to look for ways to
quickly produce masses of low-cost vaccine protein.
Wanner said the approximately 90,000 square foot Medicago U.S.A. facility is
designed to produce 10 million doses of vaccine in one month, and it has the
ability to produce vaccine more quickly.
"Making a flu vaccine with an egg-based product takes about seven months, and
with our system, it takes essentially two to three months, including clearance,"
he said. "So we're on the market much quicker than what they can do."
Wanner said that when the Medicago U.S.A. facility comes online, it will produce
doses of vaccine for a study in animals for the agency.
He said in the future, the company plans to use the facility for other projects,
such as in the production of clinical batches of vaccine for use in the
development of commercial drugs.
He said the new facility, which includes 27,000 square feet of greenhouse space,
is about 75 percent complete, and construction is on schedule.
DaVita Clinical Research has completed a Phase I-IIa cleanroom to comply with USP 797 high risk regulations demonstrating the cleanroom meets the requirements to handle compounds in a safe and efficient manner.
“The purpose of the cleanroom and the USP 797 guidelines is to reduce infection risks to patients where compound sterile preparations are prepared, as well as to protect pharmacy staff,” stated DCR vice president of clinical services, Amy Young. “Many clinical facilities are struggling to fully comply with this regulation. We are dedicated to delivering superior clinical results. The achievement of the USP 797 standard demonstrates this dedication and DCR’s commitment to our patients.”
Naples-based Arthrex adds to its Florida presence with a new biomedical operations and manufacturing facility.
Also, CROMA Pharmaceuticals, an Austrian-based company involved in the manufacture of ophthalmology, orthopedics and aesthetics products, has located a new subsidiary in Fort Lauderdale.
The University of Florida will launch construction on its new Clinical and Translational Research Building, a new home for research that will speed scientific discoveries to patients. Set for completion in January 2013, the $45 million, 120,000-square-foot complex will spark collaboration and spur medical advances by bringing together research teams from a range of scientific disciplines.
“This marks the beginning of a new era in clinical and translational science research at UF,” said Dr. David Guzick, senior vice president for health affairs and president of the UF&Shands Health System. “The CTRB will be the home of patient-centered innovation and discoveries that help secure a healthy future for the citizens of Florida and the nation.”
The building will house the UF Institute on Aging, the Clinical and Translational Science Institute and an array of other research departments and clinical programs, as well as state-of-the-art conference, training and reception areas.
“One of our most important jobs as a major research institution is to streamline the process of getting medical discoveries from the lab to the hospital or doctor’s office,” said UF President Bernie Machen. “That’s just what this building is designed to do, and at the same time it will help further advance UF’s position as a national leader in research and in patient care.”
The almost 40,000-square-foot Institute on Aging complex is funded under the American Recovery and Reinvestment Act of 2009 through a $15 million grant from the NIH National Center for Research Resources. The adjoining 80,000-square-foot portion of the facility is funded by $30 million from UF. The project will create an estimated 175 new jobs and retain 670.
“This building illustrates our commitment to creating multi-functional research facilities that take advantage of the University of Florida’s cross-disciplinary strengths,” said Win Phillips, UF vice president for research. “State-of-the-art infrastructure is critical to the university’s research mission.”
The Institute on Aging will have a one-stop facility that will make it easier for mobility-restricted older adults to take part in clinical trials, and strengthen connections among existing UF research centers, including the Claude D. Pepper Older Americans Independence Center, the CTSI and the Cognitive Aging and Memory Clinical Translational Research Program. A geriatric medicine multispecialty clinic will also be in the new building.
“This is a unique and well-timed opportunity to have basic and clinical scientists and health services researchers working together as neighbors and partners toward improving the health and independence of older adults,” said Dr. Marco Pahor, director of the UF Institute on Aging.
The CTSI, which will be headquartered in the new building, serves as the hub of an expanding research network that connects all 16 UF colleges as well as Shands HealthCare and the North Florida/South Georgia Veterans Health System.
Also in the building are extensive new research and training facilities, including clinical research programs in diabetes and muscular dystrophy and departments such as health outcomes and policy, epidemiology, biostatistics and biomedical informatics.
“The new facilities will stimulate a transformation in how we conduct clinical research by dramatically increasing the venues and resources for patient-oriented research, training and community participation,” said Dr. David R. Nelson, director of the UF Clinical and Translational Science Institute. “We will be able to truly integrate the statewide resources of the UF research community.”
Designed to meet the highest sustainability standards aimed at conserving resources, reducing pollution and making indoor spaces conducive to good health and well-being, the new facility is poised to earn a Platinum Plus rating from the Leadership in Energy and Environmental Design, or LEED, program of the U.S. Green Building Council. The building incorporates features to improve indoor air quality through the use of low-emission building materials, efficient energy production and use through photovoltaic cells, and light sensor and water conservation technologies. The project also calls for prevention of construction activity pollution and reduction of light pollution from the completed building.
Architectural design, engineering, manufacturing and construction is being carried out by Perkins + Will, Moses and Associates, AEI, SEG, Siebein and Associates, Skanska, Brame Architects, Williams-Scotsman and Brentwood Company.
“We are continually working to strengthen the university’s commitment to sustainable design,” said Carol Walker, assistant vice president and director of UF’s facilities planning and construction division. “With the CTRB, we are aiming for the top.”
Solid state chemistry services firm Triclinic labs has expanded its laboratory, adding bulk powder characterization, dissolution testing and high throughput screening to its offering.
US-based Triclinical has also installed a range of new analysis technologies, including a Rigaku SmartLab X-Ray Powder Diffractometer and CILAS 1180 Laser Particle Size analyzer at the facility in West Lafayette Indiana.
Triclinic CEO Shawn C. Comella said “The demand from our clients for materials characterization and solid-form screening and development has been overwhelming.” He added that the firm plans to hire 10 new employees over the next two years.
According to a report in the Sacramento Bee newspaper, this is the third expansion Triclinic has undertaken since it was founded in 2009.
New York University held a ribbon-cutting ceremony tomorrow for its new Center for Genomics and Systems Biology in Manhattan.
The 62,000 square-foot center will focus on genomics and systems biology, including research into how genomes encode regulatory networks in various life forms, how they respond to environmental changes, and how they evolve. These studies will involve comparative functional genomics, bioinformatic analysis, and interdisciplinary research.
The center also engages in collaborations with NYU's Courant Institute of Math and Computer Sciences, The American Museum of Natural History, The New York Botanical Garden, and Cold Spring Harbor Laboratories.
National Human Genome Research Institute Director Eric Green will deliver a speech to inaugurate the new center.
A biotech service company has opened a 60,000-square-foot facility designed to store human biological samples for a wide array of customers, including universities and research centers.
Indianapolis-based BioStorage Technologies said that its new "biorepository facility" near the FedEx hub at Indianapolis International Airport represents a $4.6 million investment.
"The future of drug discovery is in personalized medicine and genomic-based therapies, which will require an ability to store and analyze large quantities of tissue and blood samples," CEO Greg Swanberg said in a statement.
The company did not say how many people will work at the new facility.
The University of Alaska, Fairbanks, has selected David Constructors & Engineers Inc. to provide construction management-at-risk services for a new 100,000-sq-ft building to house the Life Sciences Research and Teaching Facility. The estimated construction cost is between $60 million and $68 million. Davis Constructors & Engineers Inc., 740 Bonanza Ave., Anchorage, Alaska 99518.
Genesis Plastics Welding, a U.S.-based provider of contract plastics welding and manufacturing services, is to expand its operations in Fortville, Indiana, creating up to 54 new jobs by 2014. Construction is scheduled to be completed by December 2011.
The company, which serves OEMs in the medical, military, automotive and consumer products sectors, plans to invest more than US$3.3m (€2.37m) to add 50,000ft2 of production space at its existing facility. Construction also will include a new ISO Class 7 Standard certified medical cleanroom.
Founded in 1987, Genesis attributes its recent growth to increasing demand for its proprietary plastics welding technology, ecoGenesis, which enables radio frequency welding of plastic materials previously considered difficult or impossible to heat seal without the addition of often toxic adhesives or plasticisers.
The company manufactures products including helmet padding, blood pressure cuffs, inflatable fluid bladders, hot and cold therapy packs, compression therapy sleeves, medical instrument covers, disposable heating blankets and drainage bags.
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