PHARMACEUTICAL & BIOTECHNOLOGY
UPDATE
June 2010
McIlvaine Company
TABLE OF CONTENTS
Quest Diagnostic Laboratory Expanding
Vitakem Nutraceutical Meets Requirements
SCHOTT Validates Production Line
AIT Laboratories Announces Expansion
Jackson Lab Plans Florida Translational Genetics Research Institute
Arginetix and Immune Control Merge to Form Corridor Pharmaceuticals
Phlexglobal Expands Operations to the U.S.
Pharmalucence Site Targets Biotech
Xcellerex Adding to Massachusetts HQ
Celerion Launches New Hybrid ECG Core Lab
Covance Adds New Biorepository Facility
Enavail to Build New cGMP Facility
Stanford School of Medicine Launches Center for Genomics and Personalized Medicine
Cambridge Officials OK Life Science Complex
Cambrex Receives FDA Approval for Iowa Site
Food Safety Training for Food Manufacturers
VGXI Enlarges cGMP Facility in Texas
Michigan State University Plans Plant Science Building
UT Southwestern BioCenter Opens
Bonds Sold for Incubator in Missouri
DPT Invests $15 Million in Texas Manufacturing Center
U of M Designing Nano-Tech Center on Hold
Gateway Park Gets $6.6 Million
Einstein College of Medicine Lands $9.5 Million for Diabetes Research
Harland Medical Systems and Tapemark Form Partnership
PSD Opens New Spray Drying Plant
Quay Pharma Opens New Facility
Kendle Opens New Operations Center
Chesapeake Enters Spanish Market
Vetter Invests in Pharma Storage Facility
Pfizer Continues With New R&D Unit
Capsugel Facility Receives FDA Approval
Cardiff U Launches Three New Research Institutes
Almac Adds Capacity in Ireland
Novavax Builds Vaccine Factory
Albemarle Building Lab in Belgium
Nampak Invests in New Pharma Packaging Facility
Ubichem to Supply cGMP Radiolabelled API
Surya to Invest in Production Capacity
Life Technologies, DKFZ to Create Sequencing Center
Glycos Biotechnologies to Build in Malaysia
NEC Launches Biometrics Centre in Bangalore
Boehringer Ingelheim Production Site Expanded
Nichi-Iko, Sanofi-aventis to Form Joint Venture
Max Neeman Adds Central Lab Services
WACKER Has New Facility for Pharmaceutical Proteins
PPD Inaugurates Center in Taizhou, China
Novus Expands with IQF Group Acquisition
SOHM Reorganizes Manufacturing Operations
Adcock Plans Expansions and Acquisitions
Videojet, Systech Join for Tractability to Brazil
BGI Expands into Denmark with Headquarters
Quest Diagnostics' Diagnostic Laboratory of Oklahoma plans to move into a new $20 million, 70,000-square-foot facility to house its clinical lab and administrative offices.
The added space will enable the lab to process about 16,000 blood tests a night for doctors and hospitals across the state.
Quest bought DLO in 1999 from SmithKline Beecham Clinical Laboratories. Although DLO "maintains close ties" with Quest, it was organized into "its own operations" in January 2001.
These ties enable DLO to "enjoy the services and expertise" of Quest's Nichols Institute in San Juan Capistrano, Calif., and Chantilly, VA
The lab currently manages more than 20 patient-services centers and more than 2000 physicians in Oklahoma. Also, more than 95 percent of all DLO lab tests are conducted in Oklahoma.
OvaGene Oncology announced the opening of its new clinical and research laboratory in Irvine, Calif., where the company is headquartered.
The facility will serve as the central headquarter for operations, research, and molecular clinical lab testing, OvaGene said in a statement. Technologies used for genomic testing on cancer cells at the facility include qPCR, comparative genomic hybridization, and gene expression arrays.
OvaGene is in the process of pursuing clinical laboratory licensure and accreditation. If it is successful, the company will offer molecular diagnostics to the gynecological community, it said. In addition, the company will develop diagnostics based on in-licensed technologies and internal research. The research will include collaborations with pharma firms in the oncology space in order to develop companion diagnostics.
OvaGene develops and commercializes personalized DNA-based diagnostics for gynecologic cancer.
Vitakem Nutraceutical, Inc., has provided custom manufacturing for the nutrition industry since 2003. They provide start-to-finish services that include planning, formulation, production, packaging and labeling, design and order fulfillment. Vitakem's facilities meet current good manufacturing guidelines (cGMPs) established by the U.S. Food and Drug Association (FDA), the World Health Organization (WHO) and the European Union (EU). While Vitakem partners with a range of companies, they specialize in working with small, startup companies.
SCHOTT Pharmaceutical Packaging, a division of SCHOTT North America, Inc., has announced that the Lebanon, PA facility has completed facility and equipment validations of its syringe production line, expanding production capacities for North American customers. The announcement is a first for the facility, which last year undertook more than $14 million in capital investments, including the creation of more than 40 new jobs.
In addition, SCHOTT Pharmaceutical Packaging announced the product validation for its first ready-to-fill syringe customer, with several others in process. This is a major milestone and addition for the Lebanon facility which has traditionally manufactured high-quality vials and cartridges for the pharmaceutical industry. To date, syringes have been produced in Switzerland and imported to the US market.
“We have completed operational qualification of the syringe wash line,” said Renard Jackson, Vice President of SCHOTT North America, Inc. and General Manager of its Pharmaceutical Packaging Division. “We are now prepared to assist additional customers with their commercial production requirements for ready-to-fill syringes.”
With the addition of ready-to-fill syringes to its portfolio of vials, ampoules and cartridges, the entire complement of SCHOTT pharmaceutical packaging products is now produced in North America. SCHOTT is only the second company to produce high quality ready-to-fill syringes in the United States.
SCHOTT products and production processes conform to the U.S. Food and Drug Administration’s good manufacturing practice (cGMP) standards. The production line incorporates the most advanced technologies, including dimensional camera inspection and clean room final packaging.
SCHOTT has been producing pharmaceutical products in the United States since 1992
Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the chemical and biopharmaceutical industries, has announced new services it can now provide under its United States Drug Enforcement Administration (DEA) license.
Ricerca possesses a current DEA license, which allows Ricerca to handle multiple kilos of agency-controlled Schedule II-V substances for research and development projects at its Concord, Ohio, facility. This would include preparation of Phase I to Phase II clinical bulk API supplies.
As the mission of the DEA is to enforce the controlled substance laws and regulations of the United States, it only licenses highly reputable companies to handle and produce controlled substances. Crucial criteria distinguished by the government agency include documented accountability of material usage and disposal, secure storage and strong ICH Q7A compliance. In addition, a team of experienced chemists to execute the complex synthetic routes, as well as an experienced analytical chemistry group to perform IPC testing and method development work are also a necessity.
AIT biological testing company plans to expand its operations in Indianapolis and potentially add 160 workers in the next four years.
AIT Laboratories executives announced the expansion. The $74 million project includes moving its headquarters from near Indianapolis International Airport to a site on the city's northwest side and building a new toxicology lab.
The company analyzes blood, urine and tissue samples for coroners, police agencies and hospitals around the country. It plans to hire laboratory workers and administrative staff.
Company president Michael Evans says AIT has added nearly 280 employees in the past 18 months. It now has about 475 employees nationwide.
The Jackson Laboratory expects to open its planned translational genetics research institute next year with a temporary facility that will give way two years later to a permanent campus near Naples, Fla., according to a business plan submitted to officials in Florida's Collier County.
Jackson Lab's temporary facility will house 24 employees, the plan disclosed, including "at least one" senior principal investigator in each research area — comparative genetics and bioinformatics/computational biology. That number will grow to 25 senior PIs by the time the permanent facility opens in 2013, said Michael Hyde, Jackson Lab's vice president for advancement and external relations.
By 2020, Jackson Lab expects its total workforce to grow to 244 employees, of whom more than half will hold administrative jobs and the rest scientific positions.
Those and other plans connected with the institute are tied, however, to an economic incentive package that has the state of Florida and Collier County each giving Jackson Lab $130 million, with the laboratory raising another $120 million on its own through a philanthropic campaign.
Collier officials are expected next week to announce details of the county's proposal for raising its share of the funding package. While the Board of County Commissioners is expected to decide on the package by late next month, at least one piece of Collier's funding has been determined: Up to $5 million can be set aside as the value of the 50 acres that would be donated by developer Barron Collier Cos. to Jackson Lab for the 165,000-square-foot permanent facility, which will focus on personalized medicine.
"It will house wet labs and bioinformatics and computational biology dry labs, along with a small vivarium that can be built out as needed for different genetic model organisms," Jackson Lab said in the business plan. "Cutting-edge scientific equipment planned for the facility may include high-throughput genome sequencers and metabolomic and proteomic mass spectrometry equipment among others."
The Florida campus will also include an auditorium, a conference center, and visiting scientist lab and office space.
"Development of the facility will echo that of Howard Hughes Medical Institute's Janelia Farm, taking the same modular approach to building research facilities whereby form follows research growth and function, as needed," according to the plan.
Jackson Lab's information technology facilities in Florida, the laboratory said, will include close to a quarter petabyte of usable storage, more than 800 cores of high-performance computational capacity, and 10 gigabit network connectivity to its headquarters campus in Bar Harbor, Me., as well as to national and international research networks.
"The permanent facility will include a data center that will offer petascale infrastructure upon its commissioning and will scale to dozens of petabytes and tens of thousands of computational cores over 10 years, while ensuring high availability and security commensurate with work involving human subjects," the laboratory stated.
But first, Jackson Lab plans to establish a temporary site of between 12,000 and 15,000 square feet, set to house administrative staff and bioinformatics and computational biology faculty and services staff.
"Several locations are under consideration," with a lease yet to be signed, Hyde said. "We hope to start a lease this fall, but a specific date is unknown. There are too many variables to name a date."
Using some of the government cash, Jackson Lab expects its Florida operating revenue to spike from nearly $11 million this year to $47 million in 2011 and $79 million in 2012, according to the 17-page business plan. But with PIs expected to generate grants for campus-based research and state and local funding to decline starting in 2013, operating revenue is projected to slide to $22 million in 2014. It will then climb again and is expected to hit $39.5 million in 2019 and $39.4 million in 2020.
The business plan shows Jackson Lab's philanthropic support growing steadily as well — from $126,000 this year, to $2.5 million in 2013 when the permanent facility opens, to $11.3 million in 2020.
Gov. Charlie Crist and state lawmakers have already approved the Sunshine State's planned three-year, $130 million piece of the funding package for Jackson Lab, of which the laboratory would receive $50 million during the state fiscal year that starts on July 1.
That money, however, was approved under the assumption that Congress would approve $24 billion in additional Medicaid funding, including about $1 billion for Florida. The Medicaid money was removed from a bill that passed the US House of Representatives; the US Senate has shown interest in restoring that funding, but the odds of that happening remain uncertain.
Arginetix, Inc. and Immune Control Inc. announced their merger to form Corridor Pharmaceuticals, Inc., which will develop novel treatments for vascular diseases with an initial focus on pulmonary arterial hypertension (PAH).
Corridor will develop treatments based on the first-in-class arginase inhibition platform developed by Arginetix, and Immune Control's serotonin antagonist technology. Gary Lessing, formerly the CEO of Arginetix, will serve as CEO of Corridor, and Stephen Roth, Ph.D., formerly CEO of Immune Control, will serve as executive vice chairman of the board of directors.
"This merger combines two talented teams and two complementary technology platforms to develop promising new therapeutics to treat pulmonary and vascular diseases," says Lessing. "Together, we have the resources to advance our product pipeline and manage critical clinical, scientific and regulatory activities."
C-122, Corridor's lead candidate for PAH has undergone extensive preclinical pharmacokinetic and toxicology testing. In animal models of PAH, the drug candidate prevents the elevation of pulmonary arterial blood pressure and reduces arterial hypertrophy and perivascular fibrosis. The Company plans to file an IND application for C-122 in the second half of 2010.
"Corridor Pharmaceuticals will apply two powerful, yet widely overlooked, biochemical pathways to vascular pathologies," says Roth. "These pathways are L-arginine, the major substrate involved in the formation of nitric oxide, and serotonin, a key regulator of vascular tone and pulmonary vascular remodeling."
In conjunction with the merger, Corridor Pharmaceuticals completed a $15 million Series A financing with all major investors of both predecessor companies, including: Domain Associates, Quaker BioVentures, MedImmune Ventures, NewSpring Capital, Maryland Health Care Product Development Corporation, Ben Franklin Technology Partners of Southeastern PA, Acidophil LLC, and Red Abbey Venture Partners. Proceeds from the financing will be used to advance C-122 into clinical development, and develop new drug candidates derived from both the Company’s arginase and serotonin platforms.
"Corridor Pharmaceuticals represents a rare opportunity to combine two promising technologies under a single, unified management team," says Geeta Vemuri, Ph.D., Partner at Quaker BioVentures. "We are pleased to be able to provide the team with the capital needed to advance these unique technologies into clinical development."
As co-founder and CEO of Arginetix, a biopharmaceutical company dedicated to developing and commercializing novel therapeutic small molecule inhibitors of arginase, Lessing completed license agreements with the University of Pennsylvania and The Johns Hopkins University, and completed two rounds of financings. Prior to joining Arginetix, Lessing was the executive vice president and chief financial officer of Avalon Pharmaceuticals and managing director at Deutsche Bank Alex. Brown. Corridor is based in Baltimore, Md. with offices in West Conshohocken, Pa. Corridor Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of novel, small molecule inhibitors of arginase and serotonin to treat pulmonary and vascular disorders.
AMRI has acquired Hyaluron for $27m (€22m) to enter the prefilled syringe market and expand the customer base for its existing operations.
Acquiring Hyaluron gives AMRI capacity for current good manufacturing practice (cGMP) production and sterile filling of parenteral drugs. This moves AMRI into the prefillable syringe contract manufacturing sector, which is set to grow as biologics use increases.
Having made the buy AMRI is able to offer clients a fully integrated production process for sterile injectables. This includes development and manufacture of active pharmaceutical ingredients (API), design of the criteria to formulate the injectable, and production of the finished product.
“We believe that the unique capabilities of both organizations will quickly assimilate into a larger, fully integrated GMP manufacturing provider of choice for companies desiring to capitalize on seamless technology transfer”, said Thomas D’Ambra, CEO of AMRI.
The benefits of this integration include “increased efficiency and cost benefits”, said D’Ambra.
AMRI has paid $27m, including debt, to acquire Hyaluron’s facilities, equipment and staff. The deal includes the patented Bubble-Free Filling technology developed and owned by Hyaluron.
Using the vacuum filling and stoppering technology Hyaluron can fill products without gas bubbles. This is beneficial when handling oxygen sensitive compounds, such as proteins, which can become less stable when exposed to oxygen.
Furthermore, Bubble-Free Filling creates an unfavorable environment for the growth of microorganisms and reduces the threat to sterility caused by accidental low level contamination.
From its site in Burlington, Massachusetts, US Hyaluron provides filling of liquid and lyophilized products into syringes, vials and custom containers. This can be performed at scales ranging from preclinical to commercial.
Particular expertise includes process development for difficult formulations, such as emulsions, viscous gels, suspensions, liposomes and proteins. Hyaluron also provides stability testing for clients to evaluate the shelf-life of products in different containers, such as vials and syringes.
Specialist global contract research organization Phlexglobal has announced its expansion into the United States with the opening of an office in Carlsbad, California - its first outside of Europe.
Also in the announcement, made at the 46th DIA Annual Meeting in Washington, Phlexglobal, specialists in paper and electronic trial master file solutions, unveiled Aidan Nuttall PhD as US office president.
Heading up Phlexglobal, Inc. Aidan, the co-founder and president of Abingdon Life Sciences and former president of Chiltern International’s US operation, will be working to extend the company’s client base and promote its innovative electronic Trial Master File (eTMF) services including the unique PhlexEview solution.
Phlexglobal’s move to open a U.S. operation follows a sustained period of growth in the UK and Europe, and increasing interest from current and potential US-based client companies. Aidan said: “Phlexglobal has successfully established itself in Europe with a portfolio of niche services and I’m looking forward to extending that to our U.S. clients.
“I believe we have a real commercial advantage in today’s clinical research arena. We offer a range of cost-effective and flexible support solutions allowing us to quickly become an extension of our clients’ internal teams.”
The opening of the U.S. office comes only months after Phlexglobal signed a landmark contract with global biopharmaceutical company UCB to implement a complete TMF management solution in the UK and US worth £12 million over the next five years.
Nicola Murgatroyd, chief executive officer of Phlexglobal, commented: “This has been a really exciting 12 months for us, having secured the ongoing contract with UCB and with our US client base steadily growing, the next logical step was to open a U.S. office.
Phlexglobal offers a unique combination of clinical trial knowledge, document management skills, technical expertise, personnel recruitment and training to the pharmaceutical, biotechnology, medical device, CRO and healthcare industries. Its unique electronic Trial Master File (eTMF) solution, PhlexEview, is a quality controlled end-to-end process enabling the electronic searching and viewing of centralized TMF documentation from sponsors, subsidiaries, CROs and field-based personnel from anywhere in the world at any time.
With 17 of the top 20 global pharmaceutical companies as clients Phlexglobal is committed to achieving high levels of client satisfaction.
Massachusetts-based Pharmalucence is constructing a 70,000 sq. ft. production facility to boost the contract manufacturing capacity it can offer local biotechs.
Pharmalucence produces and markets radiopharmaceuticals, using the excess capacity to provide contract manufacturing services to several clients. Constructing the new facility will give Pharmalucence the capacity and capabilities needed to expand its client portfolio.
Glenn Alto, CEO of Pharmalucence, said that the new facility in Billerica, Massachusetts, US will be a modular construction. A fully isolated suite will be installed and an automated system will allow this to feed two lyophilisers.
Once this system is online Pharmalucence will install a second fully isolated suite, said Alto. This will be used to handle potent compounds and will feed another two lyophilisers. Alto said that the new lyophilisers are 50 per cent larger than the units installed at Pharmalucence’s current facility.
Pharmalucence plans to hire an additional 25 to 30 people when the site is fully operational. Currently the company employs 75 people at its leased facility in Bedford, Massachusetts, US.
Construction of the new facility is due to start soon and is expected to be fully operational by 2012. After production begins Pharmalucence will leave its leased facility. The old site has two filling suites and has been in operation for 20 years.
To fund construction of the new facility MassDevelopment issued a $20m (€16.8m) Recovery Zone Facility Bond on the company’s behalf. TD Bank purchased the bond. Alto said that the bond accounts for two thirds of total investment in the facility.
Alto said that there is a relatively unmet need for contract production of clinical trial materials and the facility is targeting this market. Pharmalucence produces and markets radiopharmaceuticals and consequently has experience of manufacturing small lots.
Manufacturing its own products helps Pharmalucence attract outsourcing business, said Alto, because potential clients are reassured by the in-house infrastructure, quality systems and understanding of their needs.
Furthermore, Alto said that operating at smaller scales makes Pharmalucence more competitive against contract manufacturers in emerging markets. “Offshoring might make sense for commercial scale production but not for small lots”, said Alto.
Pharmalucence can also offer a number of soft benefits to offset any cost advantages offered by offshoring. Alto said outsourcing to a local contract manufacturer makes communication easier, reduces travel expenses and puts less strain on staff by eliminating overseas trips.
These issues are well understood at Pharmalucence because it has also been a user of contract manufacturing services, said Alto. The company decided to bring all production in-house after realizing the soft benefits.
Pharmalucence believes it can offer services at competitive prices. Fully automating the facility reduces labor costs at a time when workers in emerging markets are requesting more money, said Alto. These factors reduce the difference in costs between western and emerging markets.
Xcellerex is building a second cGMP FlexFactory biomanufacturing facility to support clients transitioning to their own plants and provide contract manufacturing services.
Construction of the plant in Marlborough, Massachusetts, US expands the company’s contract manufacturing operation which, in turn, helps drives growth of its FlexFactory business.
Xcellerex already operates a plant at its Marlborough headquarters and is now building another current good manufacturing practice (cGMP) facility. The new site, which is due to be finished in September, allows Xcellerex to meet a “surge in interest”, said Guy Broadbent, company CEO.
Clients installing their own FlexFactory facilities will be provided with transitional biomanufacturing services from the new facility. Broadbent said providing this transitional support helps clients speed deployment of their own FlexFactory facilities.
Furthermore, the facility will provide clients without their own production capacity with contract manufacturing services. Offering contract manufacturing allows Xcellerex to engage with clients at an early stage in their development.
As these clients grow and add in-house capacity Xcellerex can offer them FlexFactory and transition between the sites because process development has been performed.
Operating its own site also allows Xcellerex to demonstrate the capabilities of FlexFactory. "The timeline in which we will bring this cGMP facility online will dramatically underscore the leap in deployment speed that FlexFactory enables”, said Broadbent.
Xcellerex expects the facility to be operational in September, six months after the project began, and believes the costs involved are significantly lower than for a conventional facility. When operational the facility will provide prospective clients with a hands-on educational tool.
Housed at the new facility are 2,000 liter Xcellerex XDR single-use bioreactors and modular single-use downstream unit operations through bulk-product.
Hybrid ECG Core lab provides clients faster access to data, cost savings and higher quality of data. And Celerion, the premier provider of innovative early stage clinical research solutions, announces the launch of a new Hybrid Phase I/ ECG Core lab. The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion's global Phase I clinical network. Celerion's highly automated approach employs cutting-edge technology to perform automated measurement of ECG recordings, thereby minimizing cardiologist review and providing clients with faster access to data. The system also effectively identifies the small number of ECG recordings that will still require cardiologist review. This reduction in cardiologist involvement, combined with much smaller overhead compared to traditional ECG Core labs supporting global clinical trials, allows Celerion to offer significant cost and time savings to clients.
SGS Consumer Testing Services announced an expansion of its package testing services with a global program to ensure packaging integrity for medical devices and pharmaceutical products. The program – announced at EastPack 2010 conference in New York - offers one-stop testing of product containers, secondary packaging and transit packaging to evaluate the product protection capabilities, durability and environmental sustainability of all package components.
SGS' network of package testing laboratories around the world have the ability to:
Test medical and pharmaceutical product container materials for adherence to industry-standard physical, chemical and biological specifications designed to maintain the quality of the products they house. USP, EuP and other tests cover glass, plastic, rubber closure, blister packs and plastic bags, with method development and validation available for new materials.
Measure secondary and transit packaging durability by simulating conditions encountered during shipping and handling. SGS capabilities include testing for drop, stacking and weight loading, vibration, incline impact, extreme pressure changes, temperature, humidity and weathering per ASTM standards.
Assess the eco-performance of 'green' packaging designs, including the package's carbon footprint, material toxicity, and lifecycle impact from raw materials sourcing to disposal. SGS' global network of eco-design experts can both validate package performance and verify eco-claims.
These services are available at any stage of package design, from new concept development to final design selection. SGS is certified to test packaging for compliance to standards by the major accrediting organizations, including the International Safe Transit Association (ISTA), National Motor Freight Classification (NMFC), United Nations/Department of Transportation (UN/DOT), International Maritime Dangerous Goods (IMDB), TAPPI, ASTM, ISO, ANSI, UFC, IATA, ICAO and ISTA.
"This new program provides a total package testing solution for medical device and pharmaceutical product manufacturers," said Rob Parrish, Managing Director for SGS Consumer Testing Services in North America. "Companies in these industries can now have all of their package testing needs – from heavy metal/impurity detection and biocompatibility evaluation to physical performance and sustainability assessment – handled by a single source."
Covance, Inc. has opened a new 20,000 sq.ft. biorepository facility at its Greenfield, IN location, dedicated to long-term storage of clinical trial specimens. The facility can store a range of specimens, including plasma, serum, whole blood, DNA, PBMC, and tissue.
The facility offers a range of frozen storage including -20°C, -70°C, -80°C, and -150°C vapor phase liquid nitrogen, and according to the company, has the ability to withstand exposure to winds in excess of 300 miles per hour—the equivalent of an F5 tornado.
"We believe Covance has the latest technology and capacity to meet our clients' sample storage and testing needs for many years to come," said Deborah Tanner, corporate senior vice president, and president, Central Laboratory Services and Discovery & Translational Services."By adding this biorepository to our existing central laboratory facilities, we are able to quickly store samples from our central labs and biomarkers work as well as samples from other sources. Our experience in clinical trial specimen testing and storage enables us to manage the entire lifecycle from specimen draw to final destruction, which minimize the risk for our clients due to shipping and moving specimens."
Enavail, LLC, a particle engineering company has plans to build a new cGMP facility in the Abilene Life Sciences Accelerator (ALSA). The facility is designed to enhance drugs with poor water solubility, which can limit a drug’s effectiveness.
Using its lab in Austin and the planned cGMP facility in Abilene, Enavail will work with partners to provide improved formulations, product development and clinical scale manufacturing. The 1,800 sq. ft. facility will be built in compliance with cGMP and will support clinical batch production and commercial scale manufacturing. The facility is expected to be complete in September 2010.
“The strategic decision to build our new cGMP facility in Abilene was based on a thorough review of our options,” said Brian Windsor, Ph.D., president of Enavail. “The space and the services the Abilene Life Sciences Accelerator have to offer are a perfect fit for us. They will allow for ongoing support for our clients’ clinical and commercial GMP needs. We presently offer phase I cGMP clinical batch production for compounds with applications in pulmonary, parenteral, intranasal and oral delivery. The Abilene facility will allow us to support all clinical phases as well as commercial manufacturing.”
Stanford University's School of Medicine announced the creation of a new Center for Genomics and Personalized Medicine designed to integrate genomics information with every aspect of medicine, as well as draw on collaborations between Stanford's basic scientists and clinical researchers, and on technologies developed in Silicon Valley.
Stanford says the center will promote personalized medicine by building on research from the sequencing of the genome of Stephen Quake, the Lee Otterson Professor of Bioengineering and co-chair of Stanford's bioengineering department. Quake made news last August by using a technology he helped invent — Helicos BioSciences' Heliscope single molecule sequencer — to sequence and publish his own genome for less than $50,000. Researchers published results from their study of Quake's genome in the May 1 issue of the Lancet.
"The center blends highly efficient, rapid sequencing technology with the research and clinical efforts of experts in genomics, bioinformatics, molecular genetic pathology and even ethics and genetic counseling to bring advances from the laboratory to the patient," Stanford said in its announcement.
The center's director is Michael Snyder, chair of the medical school's Department of Genetics. In the statement, Snyder said the center's sequencing facility is already operating with new equipment estimated to increase its sequencing capacity by about fivefold while also "significantly" reducing the cost.
Earlier this year, Snyder led a team of researchers in sequencing the transcriptomes of human embryonic stem cells in various stages of their differentiation into neural cells, using short- and paired-end reads generated with Illumina sequencing and long reads generated with the Roche 454 FLX and Titanium platforms. They identified both known and previously unannotated transcripts as well as spliced isoforms specific to the differentiation steps.
The center's equipment also includes a Single Molecule Real Time, or SMRT, DNA sequencing system purchased from Pacific Biosciences. Stanford was one of 10 institutions that purchased the system as part of Pac Bio's early access program in North America. The company has said it expects to launch commercial sales of the system in the second half of this year.
Alexandria Real Estate Equities has won final zoning approval from the Planning Board of Cambridge, Mass., for a 1.7 million-square-foot complex of office/laboratory space and other uses in the city's East Cambridge section near Kendall Square.
The 11.3-acre Binney Street Project will combine five new life science buildings with historic structures to be preserved, Alexandria said in a statement, adding that all buildings would employ energy efficiency features consistent with buildings certified under the Leadership in Energy and Environmental Design, or LEED, program of the US Green Building Council.
"We have worked closely with the City of Cambridge on this project and look forward to moving forward with the development of a truly unique, world-class life science cluster that will attract leading research organizations, pharmaceutical and emerging biopharmaceutical companies to an already vibrant broad and diverse life science community," Tom Andrews, senior vice president and regional market director with Alexandria, said in the statement.
Alexandria did not offer an updated figure on the cost of the project. Last year after the project won a key rezoning from the Cambridge City Council, a slightly larger 1.8 million square-foot version of the project was estimated to cost $1 billion.
The Binney Street Project will nearly double Alexandria's holdings in Cambridge. Headquartered in Pasadena, Calif., Alexandria is a publicly-traded real estate investment trust already owns more than 2.1 million square feet of office/laboratory space occupied by more than 60 mostly life-science tenants.
US-based contract research organization (CRO) Novella Clinical has acquired Prologue Research to enhance its offering of oncology clinical trial services.
The acquisition continues the period of expansion that began with the OSI Pharmaceuticals deal earlier this year. Buying Prologue strengthens Novella’s position in the oncology sector, a growth market which is already the company’s single largest therapeutic area.
Prologue is focused solely on oncology drug development and this was a “key factor” motivating the acquisition, a Novella spokesperson said. To deliver their combined capabilities in this area to clients Novella is establishing an oncology “Center of Excellence”.
Establishing this unit is an acknowledgement of the experience and expertise that is needed for oncology drug development. Novella believes the unit will help it meet the sector’s challenging criteria by improving client support and helping attract and develop oncology expertise.
Prologue employs 60 people and operates an office in Columbus, Ohio, US. From this site Prologue provides a range of services from protocol development through to clinical study report and submission support.
The spokesperson said the acquisition is “very synergistic” and Novella “has long term plans to keep and grow the Columbus office”. Regarding keeping the Prologue name, the spokesperson said clients recognize the firm’s success and this will be important in any branding decisions.
Novella has experience of integrating acquisitions and will apply this to Prologue. The spokesperson said Novella will take a methodical approach to evaluating the companies’ processes and platforms and select best practices from both organizations.
A coincidental but welcome aspect of the deal is the lack of overlap between the companies’ client portfolios. Both companies focus on biotechs and larger companies seeking therapeutic expertise but have different clients in their portfolios.
The spokesperson said that these firms “tend to be underserved by larger CROs whose business model forces them to priorities larger accounts and projects”. In contrast, Novella and Prologue focus on niche therapeutic expertise allows them to offer a tailored service to small clients.
American chemicals maker Cambrex has announced its active pharmaceutical ingredient (API) manufacturing facility has completed a successful FDA inspection.
The thumbs up for the Iowa site closely follows European Union (EU) accreditation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its efforts in adhering to the principles and guidelines of good manufacturing practice (GMP).
Cambrex reported that the US Food and Drug Administration inspected the facility for four days from March 23 to March 26 of this year.
‘The facility was inspected and the quality systems used for manufacturing and release of APIs and food grade products were audited in detail for compliance,’ Cambrex said.
A general inspection by the authorities found the Charles City site to fully comply with the latest GMP principles and guidelines.
Cambrex also noted that, ‘there were no Form 483 observations made.’
Form 483 is a list of observations made by the FDA during the inspection of the facility. They are inspectional observations, and do not represent a final agency determination regarding the company’s compliance.
Teva Pharmaceutical Industries were given a Form 483 for its role in failing to correct manufacturing practices.
Reuse of syringes and vials of the anaesthetic propofol is believed to have caused of a 2008 outbreak of hepatitis. Along with Baxter Healthcare Services both were required by a court to pay a total of $500m (€408m) in fines for infecting patients.
Teva voluntarily recalled propofol made in California after 41 patients developed post-operative fever and other symptoms the company said may have indicated exposure to bacterial toxins.
Likewise, biotech giant Genzyme, Johnson and Johnson McNeil and Sun Pharmaceuticals' unit Caraco have been cited by the FDA for failing to establish and follow written procedures to ensure GMP.
“The Cambrex Charles City staff has demonstrated our commitment to adhering to the highest quality standards in the manufacture of APIs,” said Joe Nettleton, vice president operations and Charles City site director.
“We work diligently to maintain high quality standards and we have once again demonstrated our efforts to sustain and continuously improve quality platforms within Cambrex,” he added.
The FDA and the EU-GMP are the main regulatory bodies and are responsible for setting out and updating regulations as research necessary to keep up with new drugs and products.
For each step in the manufacturing, processing and packaging of items under GMP jurisdiction, specific criteria must be satisfied to make sure that drugs, medical products and blood supplies are safe for public use.
A pharmaceutical company based in Baton Rouge, LA plans to begin manufacturing protein-based drugs in Europe over the next two years.
TransGenRx CEO William Fioretti says the company will boost its employment in Baton Rouge from 38 to about 60 during that time. The company was founded in 2002.
One of the company's goals is to produce generic drugs at lower than current costs. Fioretti told The Advocate that the European Union offers a regulatory system for approving generic versions of drugs in as little as six months -- as compared with the years sometimes required to get U.S. approval.
The University of Maryland and Waters Corporation have partnered to open a facility in Maryland to train foreign food manufacturers and scientists in methods of analysis to help them meet US food safety standards.
The International Food Safety Training Laboratory (IFSTL) will be run by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a new collaboration between the University of Maryland and the US Food and Drug Administration (FDA). The IFSTL is expected to open next year.
Imports account for about 15 percent of the total US food supply, including 60 percent of fresh fruit and vegetables and 80 percent of seafood. According to the Government Accountability Office, there are about 189,000 registered foreign sites where food is made for sale in the United States, but the FDA only inspects a tiny fraction of them – just 153 in 2008.
Director of JIFSAN Jianghong Meng said: "Inspection at the border is not an option. We import so much food from other countries that the FDA can only inspect about one percent of it. The answer is to control contamination at the source."
The establishment of the International Food Safety Training Laboratory was announced at an expert working group meeting in Washington, DC, seeking to define best practices for food safety training in the Asia-Pacific region.
Dr Robert Brackett, chief science officer at the Grocery Manufacturers Association, was one of several members of the trade organization represented in the expert working group.
Dr Brackett said: “Combined with food safety legislation that places prevention as the cornerstone of our food safety system, this work to address the critical food safety training needs in the APEC [Asia-Pacific Economic Cooperation] region will help modernize our food safety system and bolster consumer confidence in the safety and security of the food supply globally.”
The IFSTL is intended to train scientists to detect both microbiological and chemical contaminants.
Chairman, president and CEO of the Waters Corporation Douglas Berthiaume said: "Waters Corporation is committed to bridging the gap between governments and industry to ensure the best science and most innovative technologies are used to make our food safe.”
President of the University of Maryland, Dr C. Dan Mote, said: “This collaboration is a superb example of how the public and private sectors can maximize their impact by combining their strengths. The new programs have excellent potential for improving food safety internationally."
The expert working group found that the four areas with the most critical food safety training needs in the APEC region were: risk assessment; laboratory capacity; incident management and supply chain management.
JIFSAN said that in addition to training foreign and US scientists in best food safety practices, it would also support the APEC forum’s goal to establish laboratory capacity building measures for the 22 member countries.
VGXI has enlarged its cGMP plasmid manufacturing facility in The Woodlands, Texas. The expansion almost doubles the size of its current facility and is intended to augment the firm’s research and cGMP manufacturing services.
VGXI Inc. is a leading manufacturer of DNA plasmids, and its cGMP and non-cGMP products have passed rigorous reviews by several international regulatory agencies. VGXI offers a wide variety of contract manufacturing services to outside client organizations. The Company’s cGMP manufacturing facility in The Woodlands, Texas is a flexible, purpose-built facility used for research, development, and clinical supply. The site includes 500-liter and 100-liter fermentors and incorporates a cost-effective process. VGX International also has initiated a project to build and operate a 3000-liter scale cGMP, DNA plasmid manufacturing facility in Asia.
Michigan State University broke ground on April 16 on a new $43-million plant sciences expansion. The project will provide state-of-the-art interdisciplinary research lab space for plant biology, plant research, plant pathology, biochemistry and horticulture programs and scientists associated with the Great Lakes Biofuels Research Center (GLBRC).
The new 90,000 sq. ft. (8,361 sq. m.) facility will feature flexible, open laboratory spaces, offices, growth rooms, growth chambers, a 220-seat auditorium and a central collaborative space for meetings and informal interaction. The project will also include physical connections between the existing plant biology, plant and soil sciences and greenhouse facilities on campus to facilitate improved connectivity and collaboration between researchers. SmithGroup is providing architecture, engineering, interiors, lab design, lab planning and site design services for the new facility, which is scheduled for completion in 2012.
The first of four planned buildings at the UT Southwestern BioCenter in Dallas, Texas, opened in early April. BioCenter is a 13-acre (5.3-hectare) biotech park.
“We anticipate that BioCenter will become an engine for development of innovative treatments and medical device technologies that will fill unmet patient needs,” said Dr. Daniel K. Podolsky, president of UT Southwestern.
BioCenter was one of nine Dallas-area companies and organizations to receive Momentum Awards in 2009 from the Dallas Regional Chamber. BioCenter received the Technology Catalyst Award, which is presented to a company or organization working to develop and encourage new technology that yields economic growth.
“We’re in an active recruitment mode for bringing in companies,” said Dr. Dennis Stone, vice president of technology development. “We are seeking companies that are complementary to research and clinical activities at UT Southwestern. That is the main driver for why a company would want to locate in this facility. The ability to collaborate with UT Southwestern’s top-tier scientists, as well as access to the world-class research facilities on our campus, sets BioCenter apart from other incubator-type facilities.”
The technology development group is in discussions with a number of companies, including local businesses with interests in medical device technologies, West Coast groups interested in establishing a drug development consortium, and companies based in Hong Kong and Israel.
“The fact that most of these companies are from elsewhere is the norm for units such as ours,” Stone said. “If you look nationwide, and in Canada and Asia, about 85 percent of the occupants of a university-associated commercialization center come from elsewhere to draw on university intellectual and technical resources.”
St. Louis County, Mo., has sold $7.1 million in bonds to develop a new incubator adjacent to the Bio-Research & Development Growth Park and the Donald Danforth Plant Science Center. The facility will house 15 to 20 plant life science startups.
DPT Laboratories has added bulk production and packaging capacity at its liquid and semi-solids plant in San Antonio, Texas in a continuation of its recent manufacturing reorganization.
The US contract development and manufacturing organization (CDMO) invested $15m (€12m) in the facility, adding two bulk production areas and three filling lines.
The expansion project also added a clinical-scale pressurized metered dose inhalers (pMDI) production unit to complement the existing 5547 sq. m. (59,685 sq. ft.) of dedicated large-scale manufacturing space already at the facility.
The San Antonio unit is one of three newly restructured “Centers of Excellence” that DPT established earlier this year in a bid to increase the efficiency of its manufacturing operations.
The CDMO’s sterile and specialty products manufacturing unit, in Lakewood, New Jersey, was given a $30m transformation in April . That project added microbiology laboratory, sterility and endotoxin testing capacity as well as environmental monitoring capabilities to existing manufacturing capacity.
A DPT spokesman Outsourcing-pharma spoke with when the "Centers of Excellence" project was announced explained that the wider manufacturing reorganization had been motivated by a “focus on specific client needs and the ability to provide customer service from personnel who are experts within a specialized area.”
This sentiment was echoed in a statement accompanying news of the San Antonio expansion by company VP of operations Mark Fite who said: “As DPT continues to grow, we always seek opportunities to increase efficiencies.”
Fite added that: “This investment provides us with expanded capacity, capabilities and ultimately more flexibility for our customers” that will enable “high-speed, cost-effective manufacturing runs.”
The company has not said whether it plans to undertake a similar capacity expansion at its R&D centre, also in San Antonio, although such a move would clearly be in keeping with its recent strategy.
For one University of Minnesota official, the wait to build an advanced research infrastructure continues.
Among the projects cut when Gov. Tim Pawlenty trimmed the $1 billion bonding bill to $680 million in March was a physics and nanotechnology building — a project that the official believes would make the university more competitive in the hunt for federal research dollars.
Instead of $53.3 million for the building, the state Legislature provided $4 million in planning money. If the university fails to get support for a supplemental budget bill next year, any hopes of getting funds will be pushed to 2012, the next time the Legislature takes up bonding.
And that delay would increase the cost of construction. In its bonding request, University officials said that the total cost would be about $80 million, including $26.7 million contributed by the U.
“The price would need to be adjusted upward,” said Steven Crouch, dean of the Institute of Technology, which houses the department of physics and who was hoping to get the funds this year. “That’s just the fact of life.”
The research building is designed to be located close to the Nanofabrication Center at 200 Union St. S.E. When finished, it would be a four story building with 155,000 square feet of space, including a mechanical penthouse.
The pre-design work was completed almost two years ago, but the university was not allowed to continue more prep work until after the legislative session concluded. Now, $6 million in planning money ($4 million from the state and $2 million from the U) will be used over the next fiscal year to firm up the building design.
The project manager from the Architectural Alliance, the Minneapolis company designing the building, said that the schematic design will be completed by mid July and construction documents will be ready by mid June of 2011.
“There is a certain amount of optimism that there would be an off-year bonding bill (in 2011) and our work path would support that,” said Carey Brendalen, project manager and principal at the Architectural Alliance.
Crouch, of the University’s Institute of Technology (soon to be renamed the “College of Science and Engineering”) is fervently hoping for that. He said that the new physics and nanotechnology building would be devoted exclusively to research — especially in research involving soft materials such as tissue. Current research infrastructure only allows the use of hard materials such as silicon.
He added that research would also involve the area of flexible electronics — that one day might lead to, say, a computer screen that can be rolled up — and cancer research among other research activities.
The new building would also allow researcher to write grants for new research equipment because there would be enough space and the proper environmental controls to house them.
“You need the right infrastructure to house such equipment and so you can’t write a proposal that will be successful if you don’t have any place to put it,” Crouch said.
One of the new spaces created would be a 5,000-square-foot cleanroom that could be used for bio-nano research and other nanoscale research. (Clean rooms are bacteria and pollutant-free spaces used in manufacturing and scientific research. A nanometer is one-billionth of a meter. A sheet of paper is about 100,000 nanometers thick. Dimensions between approximately 1 and 100 nanometers are known as the nanoscale.)
To help with the design process, the university is planning to hire a contractor soon, said Matt Stringfellow, a project manager at the University. He said the contract with that construction company will be limited to the design work to help in estimating cost. If and when the project gets money from the state, the contract will be amended to include the physical construction.
Whether the project gets funded now depends on legislators. Crouch said he believes that the Senate higher education committee supports the project, but declined to name any lawmaker.
“I am hopeful that we can be successful if not next year, the following year, but I don’t want to do anything that may the spoil the possibility,” Crouch said.
The key to the success of Worcester Polytechnic Institute’s Gateway Park, say those whose businesses and academic endeavors thrive there, is collaboration.
When Gov. Deval L. Patrick visited the park, he wanted to know what makes the place tick. The state’s $1 billion, 10-year Life Sciences Initiative has already given more than $119 million to the biotechnology industry in Central Massachusetts, including $6.6 million for a new building at Gateway Park.
Gateway Park’s Life Sciences Bioengineering Center, which opened on Prescott Street in 2007, is a thriving incubator of biomedical startup companies as well as laboratory space for WPI students. In the spirit of collaboration, WPI students work as interns in the startups and write their theses on the work being done there. The startups collaborate and push one another to succeed.
“The recombination of ideas, you almost can’t avoid (collaboration),” said Paul Wengender, chief executive officer at Blue Sky Biotech Inc. “There are a lot of smart people in here, with good ideas.”
Blue Sky Biotech has hit on a winning idea: Perform first-stage research, on a contract basis, for some of the country’s largest and most successful life sciences companies. Blue Sky has 40 employees and is expanding.
RXi Pharmaceuticals, also at Gateway Park, is expanding as well. The company is seeking to convert Nobel Prize winner Craig Mello’s research into possible cures for Lou Gehrig’s disease and Parkinson’s disease.
Another company at Gateway Park is CellThera, a tissue regeneration research program funded by the U.S. Defense Advanced Research Projects Agency.
All of these programs and businesses need more space, according to WPI President Dennis Berkey.
“This building is full of academic research and private companies, all bursting at the seams,” he said.
Supported by a $6.6 million grant from the Massachusetts Life Sciences Center, WPI will break ground later this year on a second laboratory and office building at Gateway Park, a $32.6 million construction project that will create 120 construction jobs and 142 permanent, full-time jobs.
The new building will house Blue Sky Biotech; the WPI Biomanufacturing Education and Training Center, a new research and training facility; and a public high school, the Massachusetts Academy of Math and Science. The high school will move from its current location at 85 Prescott St.
Mr. Berkey said construction of the four-story, 80,000-square-foot life sciences facility will begin in December.
The jobs created by the new center will run the gamut, from laboratory staff members, research associates and research scientists to positions in technology support, finance and accounting, said Eric W. Overstrom, a WPI professor and head of the Life Sciences Bioengineering Center. Salaries for the new jobs will range from $40,000 to $200,000 or more.
Mr. Patrick was in the city yesterday to discuss how funding from the state’s Life Sciences Initiative has been used in Central Massachusetts. The state is contributing $6.6 million to the cost of the WPI building, continuing a trend that has seen more than 64 percent of the $186 million from the state Biotechnology Initiative funneled to Central Massachusetts, according to the governor’s office. The $186 million in public funds, distributed by the Massachusetts Life Sciences Center, has leveraged $700 million in private investment, he said.
The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health has given the Albert Einstein College of Medicine of Yeshiva University nearly $10.2 million through two new grants to fund its Diabetes Research and Training Center (DRTC), which conducts genetics and molecular research, among other disciplines.
The DRTC has six cores, including ones focused on epigenomics, metabolomics, flow cytometry, animal physiology, analytical imaging, and hormone assay research.
In addition to the five-year, $9.5 million grant from the National Institute of Digestive and Kidney Diseases, the new funding includes a $632,000 supplemental grant for equipment and pilot and feasibility studies awarded through the American Recovery and Reinvestment Act.
"The ultimate goal of these studies is to develop new therapies for the prevention or treatment of diabetes," Jeffrey Pessin, director of the DRTC and a professor of medicine and of molecular pharmacology at Einstein, said in a statement.
Some of the DRTC's research efforts are conducted at the Michael F. Price Center for Genetic and Translational Medicine/Harold and Muriel Block Research Pavilion, a 223,000-square-feet facility that was completed in 2008 at Yeshiva's campus in Bronx, NY.
Harland Medical Systems and Tapemark (West St. Paul, MN) have joined forces commercialize new innovations in medical coatings. The collaboration partnership will focus on applying medical coatings to high-volume medical devices such as glucose test strips, microfluidic diagnostic strips, introducer patches, wound management dressings, and other coated medical devices or components.
Combining capabilities from both companies provides the customer with a totally integrated solution from early R&D to high volume production. The collaboration provides support and direction in the early stages of product design and coating development through optimization of the coated materials into the final production and packaging of the medical device. As contract manufacturers, products produced for Harland/Tapemark customers may include finished medical devices, device components, and drug/device combination products.
Harland Medical Systems’ expertise is in evaluating and commercializing coating materials, in developing coating application processes, and in designing and building coating equipment. Tapemark brings 50+ years of expertise in medical and pharmaceutical contract manufacturing including substrates and in-line manufacturability, coating and dispensing, die-cutting, laminating, and packaging.
The companies will collaborate to take projects from feasibility through commercialization including development, DOE, OQ and PQ, and validated full-scale production. Products will be converted and packaged in Tapemark’s multiple cleanroom suites, which are cGMP-compliant, ISO 9001 and 13485 certified, and FDA-audited for both Drug and Device.
Andy Rensink, president and COO of Tapemark, notes, “With Harland’s strong foundation in the formulation and application of coatings to dimensional medical devices, combined with Tapemark’s background in coating and converting roll goods, we marry our expertise to bring the best of both worlds to our pharmaceutical and medical device customers.”
Jon Anderson, CEO of Harland, adds "Tapemark is recognized as best-in-class meeting the manufacturing needs of leading pharmaceutical and medical companies. This position makes them the ideal complement to Harland's proven capabilities in coating materials, coating process development and coating equipment design. The comprehensive integrated solution provided through this partnership allows our customers to quickly capitalize on exciting new innovations utilizing surface enhancement technologies.”
US firm Pharma Spray Drying (PSD) extended scope of development and manufacturing offering with new R&D facility.
The contract manufacturing organization’s (CMO) plant, in Norwood, New Jersey, houses a range of spray drying technologies including a lab-scale Buchi B-290 for proof-of-concept studies and a Niro Mobile Minor 2000 for larger scale projects.
PSD said the unit will provide development-stage capacity for customers in the pharmaceutical, cosmetic and food supplement industries with subsequent commercial-scale production being provided by a Swiss CMO partner.
Spray-drying, the technique of converting liquid active pharmaceutical ingredients (APIs) to solids with price morphological control, has been something of a hot topic for the contract manufacturing sector in recent months.
PSD capacity expansion follows similar moves by Hovione , PharmaForm and GEA Niro to build in this area.
Eisai has opened a $100m (€81m), 65,000 sq. ft. commercial manufacturing and drug development site for intravenous treatments in Research Triangle Park (RTP), North Carolina, US.
The new site expands the breadth of Eisai’s manufacturing operations, complementing its existing 190,000 sq. ft. oral solid-dose facility, to reflect the composition of its drug development pipeline.
Isolator containment technology has been installed, giving Eisai the capacity to process the highly potent compounds used in its pipeline of oncology treatments. Aseptic processing suites, laboratories and other support functions are also housed at the site.
Opening the facility will give Eisai the capacity to support the commercialization and development of its oncology pipeline, including breast cancer therapy eribulin mesylate.
Following completion of Phase III trials this treatment has been submitted for regulatory approval in Japan, the US and the European Union. If successful, the product may become the first treatment to be manufactured at the new site.
Eisai has a longstanding interest in oncology and has increased its presence in the field through the acquisition of Morphotek and expansion of its infrastructure and North American sales and marketing efforts.
Eisai first established a presence in RTP in 1997 when it finished construction of an 85,000 sq ft oral solid-dose production and development facility. This was expanded in 2001 and again in 2003 to create a 190,000 sq. ft. operation.
The new facility complements the existing operation by expanding the capabilities Eisai has at RTP. To support these operations, and future expansion, Eisai opened a $22m central utilities building in 2008. This supplies power, steam, chilled water and compressed air to the facilities.
"Constructing this new facility at our current location has allowed for the seamless integration of our production and research and development operations", added Hajime Shimizu, Chairman and CEO of Eisai Inc.
US CMO Contract Pharmaceuticals (CPL) to close Buffalo plant by the end of 2011 on weak demand it attributes to pharmaceutical industry outsourcing cuts in downturn.
CPL bought the 40,000 sq. meter (430,400 sq. ft.) plant from US major Bristol Myers-Squibb (BMS) in 2005 in an effort to expand capacity for the production of both branded and generic pharmaceuticals.
But, despite investing a further $4.5 million (€m), demand and hence capacity utilization did not reach the levels the contract manufacturing organization (CMO) had expected.
Jan Sahai CPL spokesperson told the Buffalo News that CPL, which owns another facility just across the border in Ontario, Canada, decided to close its US plant because it does not expect “utilization increasing anytime soon in this economy.”
Sahai explained that: “Many pharmaceutical companies are pulling back many of the products they outsourced to fill up capacity at their own plants.”
Whether this manufacturing pullback is a genuine industry trend or something that has impacted CPL specifically remains to be seen.
The prevailing wisdom has been that pharmaceutical firms are reducing in-house manufacturing capacity and outsourcing production to CMOs to reduce costs and refocus on core innovative R&D.
However, in recent months there have been an increasing number of deals between Big Pharma firms and generic drugmakers, most recently Abbott’s acquisition of Piramal and Pfizer deals a number of Indian generics firms.
And, while these agreements have focused on boosting Big Pharma’s presence in the non-branded sector, most of the firms involved have mentioned additional low-cost manufacturing capacity as a motivation.
So, while CPL’s difficulties should not be extended to the industry as a whole, the firm’s suggestion that pharma firms are taking more manufacture in-house should at least be borne in mind by the CMO sector.
Haupt Pharma Amareg has opened several new purpose-built laboratories for pharmaceutical development, increasing its capacity for analytical development projects. The new labs are designed to optimize the workflow of development tasks, avoiding the need to share resources with routine investigations and having to schedule development activities.
Haupt Pharma Amareg development analysis is responsible for the development and validation of analytical methods and deals primarily with solid-based formulations, particularly cytostatics. The department is also responsible for approvals of clinical trial supplies. In addition, it carries out analysis related to the definition of new in-house analytical methods.
Analytical activities of the development department will run separately from the routine investigations that are carried out for quality control purposes, enabling analysis of both kinds to be planned and conducted more efficiently within the site.
According to the company, Haupt Pharma is one of Europe’s leading contract developer and manufacturer for pharmaceutical products with nine production sites in Germany (6), France, Italy and Japan. We offer tailor-made solutions for nearly all dosage forms and several special products. Our full service covers pharmaceutical development, clinical trial supplies, production, packaging and distribution. About 2,000 employees produce for an established clientele of more than 200 important international pharmaceutical companies and global players. With a clear focus on quality, safety and efficiency Haupt Pharma is an “Inspiring Partner for Efficient Solutions.”
Quay Pharma has opened its new laboratories and headquarters in North Wales. The $4 million facility brings together the company’s range of services, which were previously housed in two separate facilities. The company has also installed new equipment to meet increasing demand for its formulation development, drug delivery design, analytical method development and clinical trial manufacturing and packaging services. Approximately 65 new R&D jobs will be created during the next three years at the facility.
“The opening of our new headquarters marks another significant milestone in Quay’s short but very successful history,” said Quay’s founder, Prof. Mike Rubinstein. “We will now be able to offer an enhanced level of support and bring our expertise and specialization to an even wider client base.”
Kendle, a leading, global full-service clinical research organization, announced the company has opened its new operations center in the Special Economic Zone (SEZ) of the Ahmedabad-Gandhinagar Knowledge Corridor. The new SEZ center represents an important and strategic investment for Kendle and demonstrates the company's commitment to further invest in Asia/Pacific region to meet customer needs. The center opened Monday, June 21, following a dedication and lamp lighting ceremony presided over by Shri Jay Narayanbhai Vyas, Hon. Minister of Health and Family Welfare, Government of Gujarat, and attended by biopharmaceutical customers and the local business community.
"Growth in India is a key component of our strategy and will be very important to the future of Kendle" said Stephen Cutler, PhD, Senior Vice President and Chief Operating Officer. "Our expanded presence in Asia, and in India in particular, creates efficiencies in the clinical development process for our customers worldwide and positions Kendle as a leading provider of high-quality, innovative and cost-effective clinical development services in this growing market."
The SEZ operations center is a world-class center of excellence focusing on delivery of clinical data management, medical writing, pharmacovigilance/safety, biostatistics/programming and other knowledge processing-related services. These clinical support services are integrated under one roof, providing an efficient operations hub for Kendle in the region.
Kendle's SEZ operations center will initially employ approximately 50 professionals at the site. The unit is expected to scale up to approximately 300 associates in the near term, and is positioned to quickly expand further to meet customer demand. The unique geography of the unit, in close proximity to multiple universities as well as the city of Ahmedabad, provides a vast untapped talent pool ideal for building and expanding a high-tech workforce.
Kendle's expansion in the quickly maturing India market reflects the growing importance of the country to the global clinical research market. With a population of 1.2 billion, a growing and improving research infrastructure, an efficient and evolving regulatory setting, favorable intellectual property laws, a large pool of medical professionals and established research credentials, India is quickly becoming a world power in clinical research. Biopharmaceutical customers worldwide are increasingly demanding expanded service offerings in India to both control costs and meet commercialization goals.
Analysts at IMS health project a compounded annual growth rate of pharmaceutical sales in India of 12-14 percent for 2010 and 13-16 percent in the five years following. This trend is supported by a biotechnology market experiencing an estimated 30 percent annual growth, and the Indian CRO market, which is expected to see growth of 49 percent annually.
Pharmaceutical and healthcare carton specialists, Chesapeake has formed an alliance with carton supplier Cartonajes Leca in a move that aims to extend its production network to southern Europe.
The partnership secured by the healthcare packaging firm forms part of an overall business strategy in which its presence in France, Germany, Belgium, Poland and Holland will now be backed up with a commercial agreement with Spanish-based Leca.
Under the terms of the agreement, Leca will become the representative of both companies in Spain and will become a local source of supply. Chesapeake said the alliance was established for purely commercial reasons only and did not involve ownership or exchange of shares or investment interest.
Leca, part of the Lantero Group, produces a selection of folding cartons for the pharmaceutical and healthcare market. It currently has three production sites, two operations in Madrid and a plant in Barcelona.
“Leca is a well-respected packaging supplier and an ideal partner to further extend our presence in Southern Europe,” said Mike Cheetham, pharmaceutical and healthcare director. “This trading alliance will enhance our service to customers allowing both parties to offer a greater range of products and to jointly develop new solutions.”
Ramon Lantero, Leca’s Chief Executive Officer, said, “This alliance will strengthen our service to customers and will provide mutual opportunities for further developments.”
News of Chesapeake’s latest partnership echoes movements made by fellow pharmaceutical and healthcare packaging specialists Clondalkin Group.
Its Specialist Packaging Division now has eight European manufacturing sites in total boosted by its raft of acquisitions during the past three years. As well as the purchase of Cartonplex in Spain, January 2010 saw Lehigh Press, a Puerto-Rican pharmaceutical inserts and labels manufacturer come on board.
Chesapeake has adopted an approach in which investment is central to developing and further extending its integrated supply network.
Its acquisition of Polish label and carton manufacturer Cezar signified Chesapeake’s return to form after it was acquired by Irving Place Capital Management and Oaktree Capital Management in May 2009.
The US-based private equity houses stumped up $485m for the carton and plastic packaging group, four months after Chesapeake's fall into chapter 11 bankruptcy protection in December 2008.
Later on the firm invested in a GUK folding machine and a KBA press at its Greenford site to up production numbers for its pharmaceutical leaflets.
It also formed an international alliance in May by forming a partnership with Papcart, a Nantes-based supplier of premium cartons.
Chesapeake already has a significant presence in France operating four production plants of which three specialize in packaging for the pharmaceutical and healthcare sectors.
Vetter Pharma have begun construction of its latest storage facility in a move that forms part of Vetter’s recent efforts to expand its pharmaceutical logistical resources. Vetter's newest facility, located in Germany, adds to another new U.S facility as it seeks to meet differing but strict product storage and integrity standards worldwide.
The facility, based in Ravensburg, is primarily to be used for cold-storage and room-temperature goods as well as amenities for automatic and manual visual inspection. Space will also be provided for stability chambers, large sealed containment units that can provide controlled environmental conditions including temperature and humidity.
Vetter, a producer of aseptically pre-filled syringe systems, cartridges and vials, has invested more than 30 million Euros in the facility’s initial construction phase, which is scheduled for completion by the end of 2011.
The facility also allows for end-to-end material tracking ensuring optimized processes and high traceability. Specially secured storage rooms for visual inspection help prevent product mix-ups and cross-contamination.
"Our investment is an investment in our partnership with customers worldwide," said Thomas Otto, Vetter Managing Director.
"The facility will broaden the base for our global market supply and underscores our dedication to staying at the forefront of technology," he added.
Vetter Pharma’s move in investing in such a purpose built facility comes as the demand from Pharmaceuticals and Biologics customers to be able to track and monitor assets across the supply chain becomes ever more vocal.
With the current global biopharmaceutical market currently projected at US$48 billion, the need for an increased oversight, management, and control of environmental conditions across the entire supply chain has become a primary concern especially if the supply chain operates worldwide.
With much of Vetter’s international business within the delicate aseptic filling of liquid and lyophilized drugs, its manufacturing processes could arguably need to meet additional safety guidelines from the various regulatory bodies.
Aseptic filling is one of the areas that has seen the most growth in the pharmaceutical outsourcing sector in recent years as drugmakers keen to enter the lucrative markets have sought ways to reduce the cost of such operations.
The global market share of pre-filled syringe systems has grown to almost 1 billion units, with the European market dominating. The U.S. and Japanese markets are quickly catching up: Japan's market share in pre-filled syringe systems grew by more than 20% in 2004.
In April, Vetter announced the cleanroom infrastructure at its new Chicago facility has remained on schedule for launch of operations at the beginning of the fourth quarter 2010.
The new unit, 24,000 sq. ft. of microbiology and chemistry laboratories, includes several cleanrooms one of which, featuring a Bosch MHI 2020 automated vial filler that will focus on high-value biopharmaceuticals.
In March last year, the firm also set up a new subsidiary, Vetter Pharma International (VPI) to take charge of sales, marketing and customer services.
Pfizer continues its foray into rare diseases as it creates a new R&D unit to investigate novel therapeutics for conditions such as Haemophilia. The pharma giant joins GlaxoSmithKline and Novartis as companies looking into producing specialized drugs as a way to offset slowing sales growth and loss of blockbuster patent protection.
The new unit created within Pfizer’s Worldwide Research and Development operation aims to capitalize on Pfizer’s existing research into such conditions as Haemophilia. In the past, Pfizer have also expressed its interest in treatments for muscular dystrophy and other conditions caused by genetic mutations.
The creation of an R&D unit represents a significant strategy shift into rare diseases for the firm. In December of last year, Pfizer agreed to pay $60 million initially with a further $55 million to license the worldwide rights to Protalix Biotherapeutic's drug for Gaucher disease.
This shift also produced job cuts as the company announced its intention to shed roughly 6,000 manufacturing jobs worldwide over the next five years.
This includes approximately 300 at the Andover biotechnology plant Pfizer took over when it bought Wyeth Pharmaceuticals for $68 billion last year.
With the impending expiration of blockbusters and a slowdown in emerging pipeline candidates, industry insiders believe pharma’s passing interest in specialized markets is gaining increasing momentum.
Drugs produced for ultra-orphan diseases with high unmet needs have an easier time commanding high prices. Genzyme’s Cerezyme, another drug used to treat Gaucher disease can command prices of up to $200,000 a year while medicines for cancer can cost $50,000 or more a year.
In addition, the growing trend of pharma companies using biomarkers to improve on current methods to define populations of patients increases the prospect of smaller markets suddenly becomes more attractive and financially viable.
Pfizer joins a growing band of companies who are currently pursuing treatments for rare diseases. In March, GlaxoSmithKline (GSK) steeped up its efforts to build a rare diseases business which saw the UK pharmaceutical major launch its own dedicated R&D unit.
April also saw GSK partner up with US firm Isis Pharmaceuticals in a deal that uses Isis’ antisense discovery platform to find and develop six drugs for rare illnesses including infectious diseases and some conditions causing blindness.
The deal is the second firm the UK giant has teamed up with. Dutch biopharma group Prosensa became the first with an agreement, signed last October that focused on the development of RNA drugs for the treatment of Duchenne Muscular Dystrophy (DMD).
In June, the Food and Drug Administration (FDA) granted approval to Novartis to allow the drug Ilaris to be sold as a therapeutic for cryopyrin-associated periodic syndrome. Only 300 Americans suffer from this syndrome, an inflammatory condition caused by a gene mutation.
David Simmons, president of Pfizer’s established products business unit, said in an interview with the New York Times: “This is the first step in the pursuit of a formal strategy around orphan drugs and rare diseases.”
While there might low numbers of patients with these diseases, he said, “collectively, it’s a very large patient population with a great unmet medical need.”
Pfizer chief executive Jeff Kindler similarly commented on the reasoning behind his company’s change of direction stating the deal with the Israeli-based Protalix was, “the first of many. We’re trying to meet unmet medical needs in a way we haven’t done before.”
Of the more than 6000 diseases classified as orphan diseases, fewer than ten percent have therapies that directly address the underlying disease. According to the National Organization for Rare Disorders (NORD), a disease is considered rare in the U.S. if it affects fewer than 200,000 people. There are nearly 7,000 such diseases affecting nearly 30 million U.S citizens.
“Approximately 30 million Americans, 30 million Europeans and millions more around the world have rare diseases and for those people, there is no specific treatment,” said Peter L. Saltonstall, President and CEO of the National Organization for Rare Disorders (NORD).
“We are hopeful that this research unit will lead to additional new medicines for patients suffering from devastating illnesses for which there is no cure,” said Jose Carlos Gutierrez-Ramos, senior vice president, BioTherapeutics Research and Development.
Capsugel announced that the U.S. Food and Drug Administration (FDA) has classified its facility in Ploërmel, France as acceptable to manufacture naproxcinod, following a New Drug Application filing by a Capsugel customer. The FDA’s Pre-Approval and Good Manufacturing Practices inspection of Capsugel’s facility included an inspection of Capsugel’s Licaps Drug Delivery System for liquid filled naproxcinod capsules.
“We have built a unique value proposition that offers a complete solution for our partners, from concept to market”, said Carl Mourisse, vice president and general manager Capsugel Europe, Middle East, Africa & South Asia. “This achievement is a tangible result of our solid commitment to providing the highest level of quality and regulatory compliance services to our
biopharmaceutical customers wherever they are in the world.” Ploërmel, France is Capsugel’s first FDA approved facility serving customers around the world in the areas of clinical trial and commercial pharmaceutical products manufacturing.
Cardiff University in Wales will invest £10 million ($14.8 million) into three new multidisciplinary research institutes.
The first among these is the Cancer Stem Cell Research Institute, which aims to conduct studies that will lead to new cancer therapies. The institute said it plans to create and grow 11 research groups that will investigate the most common types of cancer, including blood, skin, colon, breast, lung, prostate, pancreatic and urological. The groups will consist of "key international players in fundamental science, translational science and clinical trials," the institute said on its website.
The institute's director will be Alan Clarke, who has recently been appointed leader of the new Pathophysiology and Repair Research Division at Cardiff's School of Biosciences. Clarke is also director of the Cardiff Cancer Research UK Centre, a partnership of Cancer Research UK, Cardiff University, Velindre NHS Trust and Cardiff and Vale University Health Board.
The institute will share the building with another new institute announced by the university. The Neurosciences and Mental Health Research Institute has been formed to translate Cardiff's basic research in psychiatric and neurodegenerative disorders into a greater understanding of disease mechanisms, classification, and diagnosis. Among research areas will be attention deficit hyperactivity disorder, autism, bipolar disorder, schizophrenia, and neurodegenerative disorders such as Alzheimer's disease, Huntington's disease and Parkinson's disease.
The third institute — the Sustainable Places Research Institute — will focus on developing environmentally sustainable solutions for cities and their surrounding regions.
Spurred by a client request for additional sachet capacity, Almac Pharma Services has completed a £2 million investment program at the company’s headquarters in Craigavon, Northern Ireland. A new facility with approximately 5,500 sq. ft. features dispensing and blending suites to accommodate 2.5 ton batches along with a sachet filling and packaging line. The facility is expected to produce more than 120 million sachets, split across various packed formats.
“This investment has allowed our client to quickly meet growing demand for one of their key future products," explained Geoff Sloan, vice president, manufacturing operations, Almac Pharma Services. "Utilizing Almac’s technical and project management expertise to deliver a complex engineering solution to an aggressive project timeline will assist our client in securing the market for this strongly performing product.”
Added Graeme McBurney, president and M.D. of Almac Pharma Services said: “This level of investment demonstrates our commitment to building long term, strategic relationships with our client partners.”
Supporting storage and wash areas complete the new facility.
Drug developer Novavax Inc. said its joint venture with an Indian company has finished building a factory in Dholka, India, that will produce flu vaccines. CPL Biologicals plans to start equipment and installation validation this month. The factory will produce up to 60 million doses of new vaccines every year. Sterile filling capabilities are also housed at the site. Novavax, which is based in Rockville, Md., said it will produce seasonal and pandemic flu vaccines using technology that enables rapid vaccine development without the use of live virus. CPL Biologicals is a joint venture of Novavax and Cadila Pharmaceuticals Ltd., a privately held drug company.
Novavax set up the joint venture, CPL Biologicals, as part of its strategy of partnering with pharma firms to expand its vaccine production capabilities to other counties.
Rahul Singhvi, president and CEO of Novavax, said the facility has “an efficient, reliable and flexible vaccine production process" which will supply India and other countries.
CPLB will also develop, manufacture and sell biosimilars and diagnostic kits.
US-based Albemarle is building a kilo lab in Louvain la Neuve, Belgium to meet demand from European clients for services beyond bench scale.
European clients are currently supported by a R&D group but have been requesting Albemarle take its local support to the next stage. In response Albemarle is building a lab for kilo and multi-kilo work, “creating an even closer and longer working relationship” with European clients.
“Our customers’ needs for a fast service, in local geographies, really made this step an imperative”, said a company spokesperson. Previously Albemarle could only offer kilo lab services at sites in the US.
Expanding the service into Europe will ease communication, allow for direct collaboration and in turn help hasten the development process. Locating the lab in Belgium, which has “a logistically ideal position within the European Union (EU)”, further helps link Albemarle to its clients.
Furthermore, Louvain la Neuve is the location of Albemarle’s European headquarters and custom services R&D labs. Consequently, the site already has “infrastructure and technical talent that can easily be deployed to serve our customers’ kilo scale requirements”, said the spokesperson.
Work on the lab began earlier this year and is due to be operational in the third quarter of 2010. Albemarle’s fine chemistry services R&D group, consisting of five chemists and technicians, will staff the kilo lab. The lab will occupy 20 sq. m. (215.2 sq. ft.) within the existing site at Louvain la Neuve.
Operating the new non-current good manufacturing practice (cGMP) site will allow Albemarle to scale up processes it has performed at lab scale to prove they are commercially viable.
A technology transfer can then shift the process to one of Albemarle’s commercial facilities with a high degree of confidence. “The lab is a true miniplant and can do reactions, distillations, filtrations and drying”, said the spokesperson. Equipment includes 50-litre glass lined vessels.
Albemarle will use the lab to make a few kilograms of a client’s new product for testing and customer sampling. Products will include very early stage active pharmaceutical ingredients (API) for toxicology studies or advanced starting materials.
The lab will serve a number of industries, with pharma expected to account for half of its business. Albemarle works with a large number of pharma clients and has significant experience. This, coupled to international regulatory agency demands, will drive pharma business.
Nampak Europe is to invest €4.5m ($5.4m) in a new purpose-built factory to replace its Wolfen facility in a move to reduce product costs in the northern European arm of the business.
The move is another indication of the group’s intentions to invest in new capacity and reinvest in its own technology. Nampak has had tough 18 months, which has seen the firm undergo a major restructure of its European operations.
The move coincides with an expiring lease on the existing premises in Wolfen, Germany. The final decision was taken after plans to add space and improve the layout to enhance production were deemed unfeasible.
The new plant will be constructed adjacent to the existing site enabling Nampak to relocate into a modern purpose-built facility that retains the original Wolfen workforce.
Nampak manufactures a wide range of products for the various industry sectors, including cartons, self-adhesive labels and printed foils used in blister packs. The new facility will primarily be used to produce leaflets for the pharmaceutical market.
“The initial investment will be a in the region of €4.5m and further investments will be made in due course to keep up to date with new technology and for growth” said Tom Reid, Nampak Europe chief executive.
“Production at the new site will commence in the late summer of next year,” he added.
2010 has seen Nampak beginning to emerge from an intense period of reorganization in an attempt to streamline productions and turn around its loss-making operations.
Last November chief executive Andrew Marshall's laid out plans to "sell, fix or close" one in five of the group's loss-making facilities worldwide in addition to scaling back on capital expenditure across the group.
In addition, its pharmaceutical and healthcare packaging business’s management team were reshuffled in a bid to improve efficiencies across its 12 sites in Europe.
The decisions seem to have had an effect. As well as the group's Leeds, UK carton printing site returning to profitability, the former Storey Evans site in Bradford, UK has now been fully integrated into the Nampak’s Healthcare business.
Nampak Healthcare in Bradford, which prints cartons and patient information leaflets for the pharmaceutical and healthcare industries, recently invested £1m in scanning technology - the first of its kind in the UK.
In figures announced by Nampak Europe's South African parent company, European sales of £175 million ($252.9 million) were similar to that achieved in the year before. Trading profit had increased to £8.9 million, an increase from £6.7million achieved in 2009.
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
The rise of microdosing has increased interest in radiolabelled compounds, prompting companies including PerkinElmer to bolster capabilities. Ubichem gained radiochemical capabilities through an acquisition in 2007 and since then has worked to enhance its offering.
József Répási, managing director of Ubichem, explained that the latest step in these efforts has been the expansion of current good manufacturing practices (cGMP) to the radiolabelling laboratories.
Equipment has been upgraded and installed to give the Ubichem isotope synthesis group, which has extensive experience working with radiolabelled compounds, a site that is in compliance with cGMP.
Having taken these steps Ubichem had the site inspected by Hungarian authorities for the production of radiolabelled cGMP active pharmaceutical ingredients (API). Répási commented that the site has also been successfully audited by a client.
An agreement between the Hungarian authorities and the EU means the approval allows Ubichem to supply the European market. Répási said that there has been a definite increase in demand for radiolabelled APIs and Ubichem is now well equipped to serve this growth market.
The shelf-life of radiolabelled APIs poses difficulties for shipping. To overcome these challenges Ubichem has outsourced shipping to a specialist company with more than 20 years of experience in the radiochemistry sector.
Répási explained that packaging compliant with API and radiolabelling guidelines is used. The radiolabelled APIs are then in shipped in dry ice at -78ºC to maximize shelf life.
Ubichem has sought to ship radiolabelled APIs to the US but the compounds’ shelf-life has limited penetration into the lucrative market, added Répási. Also, there is significant competition from US-based radiolabelled API producers. Japan also represents an opportunity.
Indian API manufacturer Shasun Chemicals and Drugs turned a previous loss into profit for Q4 of this year as it seeks to make a dent in the biosimilar manufacturing sector.
The Chennai-based company is seeking to build on its two active pharmaceutical ingredient (API) plants in India and one in the United Kingdom as it bids to head up India’s foray into biotechnology.
For the quarter ended March 31 2010 the company posted a net profit of Rs 10.06 crore ($2.1m). This is compared to the same period last year where a net loss of Rs 45.25 crore was reported. Shasun attributed these figures to improvements in its active pharmaceutical ingredients (APIs) and finished dosage businesses.
This figure translated into a consolidated net profit for the year ended March 31 2010. Shasun posted a gain of Rs two crore that compared favorably to the net loss of Rs 141.39 crore in 2009.
Net sales were buoyed by the company’s continued efforts in contract & custom pharmaceutical manufacturing. Its offerings in custom synthesis and impurity profiling demonstrate where its strengths lie as it posted consolidated net sales of Rs 784.07 crore for the year ended March 31, 2010.
The corresponding period of last year saw the company post net sales of Rs 750.83 crore, an increase of 4.2 per cent.
Shasun has previously stated that on a consolidated basis, API and its intermediate business contributed 50 per cent of the turnover of the company. On a standalone basis, they contributed 70 per cent of the total sales.
Indian biotech
The figures and business strategy reflect a marked growth in the company and are indicative of the events occurring in India. With an abundance of government initiatives and biotech parks under construction in cities like Hyderabad, Bangalore, and Pune, India aims to be the hub of biotechnology activity in a similar vein to that of Singapore.
Shasun’s current API portfolio consists of ibuprofen, ranitidine, nizatidine and gabapentin among others.
In July 2009, Shasun launched streptokinase, a fibrinolytic drug, used for the treatment of heart attacks. Streptokinase, a biosimilar, is the first line of defense in almost all cases of heart attacks.
Currently, the biotech division has made considerable investments in doubling its capacity and will be able to manufacture Streptokinase bulk API equivalent to approximately 200,000 vials a year. Two other biosimilars are in the pipeline and are expected to be launched in the next financial year.
India-based Surya Pharmaceuticals is planning to raise Rs 500 crore ($100m) to fund construction of an active pharmaceutical ingredient (API) production plant, according to local media reports.
The money will be raised over the coming months through a number of channels and used to funds Surya’s investment plans. Having expanded into the pharmaceutical retail business the company is now looking to bolster its API supply and formulation operations.
Investment will be made in a new API plant near Chandigarh in northern India. A timeline for construction of the plant is yet to be released but when operational it will produce APIs for a range of therapeutic areas, including cardiovascular.
Construction of the plant will help support growth at Surya. For the year ending March 31, 2010 net sales were Rs 113020 lakh ($241m), up from Rs 72292 in 2009. This helped operating profit to increase from Rs 2529 lakh in 2009 to Rs 3805 lakh in the most recent full year financials.
Investments to drive growth in this fiscal year are already in place. Surya is nearing completion of an Rs 320 crore facility in Samba in northern India. The site will produce APIs and formulations and is expected to be partly operational next month, with full production beginning in December.
As well as supplying APIs Surya also operates a contract research and manufacturing services (CRAMS) unit in Punjab, India. The unit has received “serious enquiries” from the US, Surya said.
By making these investments Surya believes it can achieve over 40 per cent year-on-year organic growth. The company is also looking to grow inorganically through overseas acquisitions and it is in discussions with targets in North America.
Life Technologies and the German Cancer Research Center (Deutsches Krebsforschungszentrum, or DKFZ) have formed an exclusive partnership to create the National High-Throughput Sequencing Center in Germany.
The partners said that the new center will be the largest sequencing facility in Germany and the first national sequencing center in Europe dedicated to systems biology.
The center will use 10 of Life Technologies' SOLiD 4 hq systems, which have been acquired by DKFZ. Researchers at the new center plan to initially sequence 1,000 whole human cancer genomes for Germany's national contribution to the International Cancer Genome Consortium.
"This center will be the first facility that will systematically bring high-throughput sequencing technologically into systems biology applications on a large scale," Life Technologies President and COO Mark Stevenson said in a statement.
The facility will be partly funded by the German Federal Ministry of Education and Research. Further financial and other terms of the collaboration were not disclosed.
Celerion has implemented a hybrid ECG core lab across its Phase I network to help clients get through this early developmental stage “much cheaper and much faster”.
The system uses Bluetooth-enabled Holter monitors to collect electrocardiograph (ECG) data. This is then automatically analyzed, measured and assessed to determine if cardiologist review is required. Most ECGs will be automatically entered into a database with annotations.
Joy Olbertz, director, cardiac safety services at Celerion, said that the project aims to benefit from new technology. MDS Pharma Services began the work on the system and now, after acquiring the assets, Celerion has implemented it across its Phase I sites.
The process starts with the Bluetooth-enabled Holter monitors. These can collect ECG data over 48 hours, giving them an advantage over other systems that are only capable of 24 hour monitoring.
Olbertz said that many clients want to take ECG data 24 hours after dosing. This leaves clinics using 24 hour Holter monitors with very little flexibility, said Olbertz, and consequently Celerion believes adopting the 48 hour model will improve its operations.
Data collected by the monitors is downloaded and Antares software automatically extracts periods of ECG recordings with minimal heart fluctuations and anomalous interfering signals.
Olbertz said that this data is fed through an ECG measurement algorithm. A second program then analyses the information that the algorithm outputs and decides if cardiologist review is required.
The proportion of ECGs that are sent for further review is study dependent but is in the region of 10 to 20 per cent. Olbertz said the system uses cautious filtration parameters to ensure all ECGs that need reviewing are seen by a cardiologist. Also, all the ECGs are from healthy volunteers.
There are also benefits to having the clinic manage the ECG core lab. This gives the clinic direct oversight of the operation, provides a single point of contact for sponsors and improves communications. These factors reduce costs and minimize the likelihood of errors occurring.
Before implementing the system Celerion outsourced its ECG activities. All operations have now been brought in-house and this, coupled to the technological advances, gives Celerion a “huge advantage”, said Olbertz.
The system “just makes sense”, said Olbertz, and should allow clients to get through this stage of development “much cheaper and much faster”. Initial client feedback has been “very positive”, said Olbertz.
Celerion developed the system in collaboration with AMPS-LLC and Global Instrumentation. The process was “truly a partnership” to find the most efficient route to data output, Olbertz said. Celerion’s involvement in the development process means the system is tailored to its needs.
Glycos Biotechnologies (GlycosBio), a biochemical company focused on metabolic engineering and microbiology innovations for the production of sustainable biochemicals, inked an agreement with Bio-XCell for assistance with construction of its biochemical plant and biotechnology R&D facility within Bio-XCell’s industrial park in Malaysia.
Construction of the plant will begin in Q3 2010 with an expected completion date in early 2012. In addition to the partnership with Bio-XCell, GlycosBio will also work closely with the Malaysian Biotechnology Corporation, the national agency set up by the Malaysian government for the development of biotechnology in Malaysia.
“We see the palm-oil industry as being a long-term source of renewable feedstocks, which directly align with our technology,” says Walt Burnap, president of Glycos Biotechnologies. “Using GlycosBio’s microbial strains and related downstream engineering processes will allow the Malaysian palm-oil industry to meet the market demands of the 21st century.”
“As the biggest producer and exporter of palm oil and having one of the largest oleochemical industries in the world, Malaysia is aggressively seeking alternative approaches to ensuring more sustainable production methods,” explains Dato’ Iskandar Mizal Mahmood, CEO of BiotechCorp and chairman of Bio-XCell. “Our partnership with GlycosBio supports Malaysia’s interest in developing and creating new business opportunities for international companies focused on advanced biotechnology. By implementing technology from biochemical and biotechnology companies like GlycosBio, palm-oil and oleochemical producers will be able to convert lower-value product streams into renewable feedstocks that can then be used to produce greener, more valuable biochemicals.”
GlycosBio’s technology facilitates the metabolic engineering of microbial strains to consume multiple nonsugar-based, low-value feedstocks for the production of sustainable chemicals and advanced ethanol. By designing differentiated microorganisms, GlycosBio’s bioconversion technology reportedly lowers production cost and provides a nonfood energy balance savings to the chemical and biofuel industries.
NEC Corporation has started its "NEC Biometrics Excellence Centre" (N-BEC) in Bangalore, India aiming to accelerate the expansion of its global multi-modal identification solutions and integrated security solutions business.
In February 2010, NEC announced its mid-term growth plan that targets an increase in the company's public safety business to Rs.5,054.80 crore (100 billion yen) through capitalizing on group-wide resources. The establishment of N-BEC is regarded as one of the first key steps towards realizing this goal. Looking forward, NEC will continue to promote its overseas business by establishing NEC centers in five regions and aiming for Rs.50,548.00 crore (1 trillion yen) in international sales.
NEC has been developing biometrics matching technologies since the 1970's and its technological superiority in biometrics identification has been proven by several accuracy tests conducted by the National Institute of Standards and Technology in the U.S.
More than 200 of NEC's biometrics solutions have been utilized by a broad range of agencies in over 30 countries throughout the world. A wide variety of government and private agencies use these solutions, including law enforcement, border control, civil identification and national election systems that require large scale, accurate and rapid biometrics matching.
NEC will capitalize on its central competencies in engineering, geographic and technological expertise to drive the development of N-BEC.
As a core engineering competency centre, N-BEC will enhance NEC's worldwide solution engineering capabilities in the expedited delivery of customized multi-modal identity solutions.
Boehringer Ingelheim celebrated the topping-out ceremony for a new production site in Ingelheim. EUR 119 million has been invested in the expansion. The additional manufacturing capacities will secure our ability to meet the expected global requirement for the innovative anticoagulant, dabigatran etexilate (Pradaxa®). The new $160-million plant is expected to be completed by 2011. The expansion will triple production at the Boehringer plant. The investment is linked to 120 attractive workplaces at the family-run company’s head office.
“This is not just about increased capacity for production of a highly innovative new medicine. The plant’s construction is also a reflection of our company’s innovative capacity and the confidence this gives us for the future,” commented Professor Wolfram Carius, member of the Board of Managing Directors at Boehringer Ingelheim and responsible globally for human resources and operations. “After all, this plant produces the prospect on which hundreds and thousands of patients are pinning their future – our innovative anticoagulant, dabigatran etexilate.”
At the end of March 2008, dabigatran etexilate was approved throughout Europe under the trade name of Pradaxa® for the prevention of thrombosis and potentially life-threatening pulmonary embolisms following hip or knee replacement surgery. Boehringer Ingelheim is also preparing to meet market needs for another, far greater indication, i.e. prevention of stroke in patients with atrial fibrillation, the most common form of arrhythmia.
Patients with atrial fibrillation are at a five times greater risk of stroke; strokes associated with this are often particularly severe. The only options available up to now were the vitamin K antagonists, an active ingredient class which is more than 50 years old. While these give patients good protection from stroke, they have numerous limitations and are often very difficult to administer. A major international comparative study with the vitamin K antagonist warfarin, in which more than 18,000 patients took part, demonstrated at the end of 2009 that dabigatran etexilate could prevent an additional million cases of stroke caused by atrial fibrillation worldwide each year – saving a lot of people from the prospect of spending their lives in a wheelchair.
“Boehringer Ingelheim is a research-based company whose core business is researching, developing and manufacturing innovative medicines with therapeutic advances such as Pradaxa®, which was developed at our research and development site Biberach,” stated Christian Boehringer, Chairman of the Shareholders’ Committee at Boehringer Ingelheim. An important component of the value creation chain is the production of pharmaceuticals and the highly qualified employees involved in the process. They are an important factor in the company’s success, also and especially in the anniversary year. “125 years of Boehringer Ingelheim also means 125 years of research and development in Germany”, said Christian Boehringer.
In May 2009, Boehringer Ingelheim had inaugurated the first module of the new plant, invested EUR 64 million and created 60 new jobs at the Ingelheim site. Since then, this plant has manufactured active ingredient pellets for Pradaxa® in three complex process stages.
Japanese generic drugmaker Nichi-Iko Pharmaceutical Co. and Sanofi-aventis of France said they have agreed to form a new joint venture in Japan to manufacture and market generic drugs.
The two firms are the latest to vie in the growing generic drug market in Japan, which Sanofi-aventis aims to break into ahead of its other foreign rivals. Generic drugs are priced lower as they are made of ingredients for which patent production has expired.
Sanofi-aventis Nichi-Iko K.K., to be held 51 percent by the French firm's Japanese unit and 49 percent by Nichi-Iko, will be set up in June. The new firm will be headquartered in Tokyo.
Nichi-Iko will also issue new shares to Sanofi-aventis in a third-party allocation worth approximately 4.4 billion yen as part of the deal to form the joint venture.
Following the new share allotment, the French drugmaker will own a stake of 4.66 percent in the Japanese firm.
As a first step to their partnership, Sanofi-aventis Nichi-Iko will market Amoban, which is a treatment for insomnia, the two companies said. Sales of Amoban in fiscal 2009 totaled 5.1 billion yen.
"Both companies continue to explore additional opportunities for the development of the joint venture in the generic market in Japan by combining Nichi-Iko's expertise in manufacturing, development and distribution of generics in Japan and Sanofi-aventis' resources and global portfolio of generics," said a statement released by the French drugmaker.
Olivier Charmeil, senior vice president of the Asia Pacific & Japan operations of Sanofi-aventis, said in the statement that the French firm hopes to "develop a strong presence in the fast-growing generic market in Japan," by providing it "with high quality and affordable pharmaceuticals."
Sanofi-aventis is a leading global firm that focuses on new drugs and also has a generic drug business in Eastern Europe and South America.
Headquartered in Toyoma City, Nichi-Iko's main business is generic medicines.
Dietary supplement and functional food ingredients company, BI Nutraceuticals is adding a fifth mill at its Suzhou manufacturing capacity to boost output by 35 percent in response to customer demand.
The company’s president and CEO, George Pontiakos said: “This will provide even more traction in serving the rapidly growing Chinese market. It will allow quicker response time and improve our time-to-market capacity.”
About 20 percent of the plant’s output will be devoted to the Chinese market with 10 percent dedicated to the rest of the Asia Pacific market. The company was unable to confirm the volume of the plant’s output.
The plant processes up to 700 botanical ingredients including Echinacea and cinnamon, ginger root, bee pollen, mung bean and ginseng.
Pontiakos is upbeat about the prospects for growth in the Chinese health supplements market. “The Chinese market is growing significantly. From Shanghai to Guangzhou (south along the nation’s seaboard) the country is becoming increasingly industrialized and the ability to grow (home-produced) herb products is reducing.”
When people move from rural to urban areas they bring with the awareness of the need for traditional treatments but not the means to produce them, he added. “Busy consumers haven’t the time to grind herb root products and increasingly they are looking to source their health efficiency from pills.”
Also, after China’s devastating melamine contamination crisis, consumers value the re-assurance of knowing that their supplements are produced to exacting US safety standards, said Pontiakos. “Chinese consumers want very high quality products after the melamine scandal. The first thing they look for on the label is US pharma specs (specifications).
BI Nutraceuticals offers more than 200 ingredients that have been determined as safe for use in foods and beverages by the Food and Drug Administration (FDA)or The Flavors and Extracts Manufacturers Association (FEMA).
In addition to boosting supply of health ingredients to the Chinese mainland the new manufacturing capacity will also support the company’s US operations. “This facility also houses a full-service quality assurance lab to test all extracts and ingredients purchased in the region to ensure they are free of contaminants prior to being shipped to the US," said Pontiakos.
Commissioned in 2007, BI Nutraceuticals’ 75,000 square foot manufacturing facility is located in Suzhou, Jiangsu province, Eastern China. On site are milling services designed to deliver a broad range of particle sizes and a steam sterilization unit.
The company claims its Protexx HP(R) process is the industry's only species-specific, organic sterilization method which was installed at a cost of $1m.
According to a company statement: The “…. Protexx HP Steam Sterilization technology complies with recent changes to Federal regulations that prohibit ethylene oxide (EtO) and irradiation as sterilization methods for dietary ingredients and nutritional supplements.”
India-based CRO Max Neeman has established central lab capabilities in India to support clinical trials, starting with a Phase II oncology study.
Prior to expanding into central lab services the contract research organization (CRO) outsourced these activities to its partners. Max Neeman intends to continue these relationships and supplement them with its in-house capabilities.
Ajoy Kumar, CEO of Max Neeman, explained: "We believe in continually expanding our service list and will continue to work closely with existing central lab partners to provide accurate results in the shortest possible turnaround time.”
Study requirements will be compared to in-house and outsourced capabilities to ensure that the central lab services Max Neeman offers clients are suitable for the trial, added Kumar.
The central lab is housed in a Max Healthcare hospital and has achieved National Accreditation Board for Testing and Calibration Laboratories (NABL) 15189:2007 / National Accreditation Board for Hospital and Healthcare Providers (NABH) accreditation.
Max Neeman has equipped the lab to be fully automated and operate 24/7. Services include hematology, histopathology, cytopathology, biochemistry, immunology, serology and flow cytometry.
For the Phase II oncology trial Max Neeman will provide serum cytokine analysis, peripheral T cell assays, immunocytohistochemistry, human leukocyte antigen (HLA) typing and other services.
Earlier this year Max Neeman enhanced its electronic data capture (EDC) offering through an agreement with Germany-based Amedon. The deal added Amedon’s EDC tool to Max Neeman’s offering.
Amedon designed its system to ease data entry and capture at the site end, offer serious adverse event reporting alerts and allow for direct capture of laboratory inputs.
This agreement was followed earlier this month by a deal to provide EDC for Phase IV trials. Under the terms of the deal, Max Neeman is providing EDC for trials run by the International Collaborative Cancer Group and Institute of Cancer Research Clinical Trials and Statistics Unit.
Generic drugmaker Teva Pharmaceutical Industries Ltd. said it will spend $56 million to expand a Canadian production plant.
The Israeli company said the province of Ontario will provide a $6.5 million grant to Teva Canada to keep 182 high-skilled workers and hire 20 new employees. The plant is in Stouffville, Ontario.
Teva Pharmaceutical employs 35,000 people worldwide.
Wacker Chemie AG officially opened a new production facility for pharmaceutical proteins (biologics) in Jena. The new plant is part of the Munich-based chemical company’s investment program to enlarge its biotech operations. The expansion enables WACKER to accommodate its customers’ rapidly growing demand for biotechnologically manufactured pharmaceuticals. Biologics are used to treat, among other things, cancer, multiple sclerosis and hepatitis. The expansion, together with the new building for process development and quality control already completed last year, brings WACKER’s total investment in the Jena facility to some €18 million.
WACKER has substantially boosted capacity at its Jena site in order to cope with a growing need for high-efficiency biologics production processes, and to meet rising customer demand. The existing GMP-certified (Good Manufacturing Practice) facility now has twice as much production area. A completely new facility for product-purification enables up to three times higher product yields per batch. The new unit meets the GMP requirements of both the US Food and Drug Administration FDA and the European Medicines Agency EMEA. Wacker Biotech can now provide those customers who have biopharmaceuticals at an advanced development stage with sufficient commercial capacity to supply the market.
“Demand for advanced biotech products is growing worldwide. Innovative, biotechnological processes such as WACKER’s secretion system ESETEC® allow us to meet demand and continue to shape the developments in biotechnology here in Germany,” WACKER Executive Board member Auguste Willems said during his speech to commission the new facility.
To accommodate growing customer inquiries, the facilities of Wacker Biotech GmbH have been greatly expanded over the last two years. The around €18 million investment by the WACKER Group at Jena’s Beutenberg Campus encompassed two projects: in addition to the expansion of the GMP facility, a new lab building for process development and quality control which was built and put into operation back in 2009.
“We now have an ideal system for developing the sophisticated processes and analytical techniques of modern, microbe-based biologics,” explains Dr. Thomas Maier, managing director of Wacker Biotech GmbH. “This allows WACKER to optimize the entire process chain, from lab operations to industrial GMP production. Customers thus benefit from a full process and analysis package provided from a single source. And with the expansion of our production capacities, we can now make our innovative ESETEC® secretion technology available to still more customers.”
PPD has opened a vaccine clinical research center in Taizhou, China. Through the center, PPD will provide clinical-monitoring services to global and local biopharmaceutical companies seeking to develop vaccines in China.
Located at the Taizhou China Medical City, the center will help biopharmaceutical companies address unique requirements for conducting vaccine clinical trials in the country. Vaccine studies in China are conducted by the Chinese Center for Disease Control and Prevention instead of at Phase I clinics or by investigators at hospitals. Additionally, these trials require thousands of patients for enrollment, compared to hundreds for studies conducted in other countries. Yet, China has a short recruitment period for vaccine trials, PPD points out.
“The vaccines market is one of the fastest growing segments in the industry, and in China the clinical trial market is growing at about 20 percent each year,” according to Simon Britton, PPD’s V.P. of clinical development for Asia Pacific. “Our strong expertise in vaccine clinical research and large presence in China make us well positioned to help our clients ensure adherence to global standards while addressing unique requirements for monitoring vaccine studies.”
PPD opened its first office in China in 2003 and says that it is now the largest contract research organization in the country with nearly 1,100 employees. Its acquisitions of Excel PharmaStudies and BioDuro last year strengthened the company’s drug discovery and development services in the country.
Through the center, PPD is expected to provide clinical monitoring services to global and local biopharmaceutical companies seeking to develop vaccines in China.
Additionally, the center will help biopharmaceutical companies address requirements for conducting vaccine clinical trials in the country.
Specialist animal nutrition company Novus International has acquired IQF Group, a Spanish specialist in carotenoids and essential oils for food and feed, further expanding its human nutrition profile.
Novus International branched out into human nutrition in November last year, when it set up Stratum Nutrition, with the stated intention of applying its experience in animal nutritional research and innovation to developing a portfolio of specialty and functional ingredients that target business-to-business manufacturers of foods, beverages and dietary supplements in North America and Europe.
Novus said that immediately following the acquisition of IQF Group it would focus on integrating the animal nutrition facet of the company, but that the human nutrition side quickly would follow. The IQF branded products that are expected to be moved under the Stratum Nutrition umbrella include Betacol (beta-carotene), Capsicol (capsanthin), Lutecol (lutein), Canthacol (canthaxanthin) and Zeacol (zeaxanthin).
President and CEO of Novus International Thad Simons said: “Incorporating these new technologies into our existing product base will enable Novus to better serve our customers worldwide.”
Terms of the deal have not been disclosed.
A spokesperson for IQF Group said in a statement: “The IQF Group has enjoyed an excellent partnership with Novus since 2001 and this acquisition is a logical and strategic next step. We are confident that the complementary aspects of IQF and Novus cultures and products will build upon the success of our 40 year legacy.”
Stratum Nutrition said that moving into human nutrition is a natural progression for Novus. And this latest move adds to others the company has made in the nutra space since its inception, such as the signing of a global deal with Belgian biotech firm, KitoZyme, to exclusively distribute the company’s vegetarian chitin-glucan ingredient in February.
Stratum Nutrition’s director Jeremy Moore said when Stratum Nutrition was set up: “Many of the challenges faced in animal health and nutrition are similar to the challenges we face as humans. For instance, optimizing bone strength and joint flexibility, supporting digestive health and building lean muscle mass are areas Novus has been very successful in helping traditional customers with for many years.”
Novus is privately owned by Mitsui & Co. (U.S.A.), Inc. and Nippon Soda Co., Ltd.
The Ahmadabad, India-based firm has opened a new 410sq.meters (4,411 sq. ft.) unit that will house its nutritional products business, meaning that its existing facility will be used solely for the manufacture of its range of non-branded drugs.
SOHM says separating pharmaceutical and nutritional production ops allows for greater scalability and faster manufacturing turnaround.
Shailesh Shah, SOHM VP of corporate strategy, said that: “[the new] manufacturing facility and laboratory staff is complementary to our pharmaceutical manufacturing facility and will allow for rapid turnaround and competitive pricing as our purchase orders continue to increase.”
Shah added that the move positions the company as a full-service pharmaceutical and nutritional enterprise.
Adcock Ingram recorded an 11 per cent rise in profit in the first half of 2010 and is looking to continue this upwards trend through manufacturing expansions, plus local and overseas acquisitions.
Expansions and acquisitions underpin South Africa-based Adcock’s efforts to develop its pipeline and remain an attractive partner for multinational pharma companies.
The acquisition is focused on three geographic regions: South Africa and adjacent areas, sub-Saharan Africa and overseas. Through implementing this strategy Adcock has strengthened in its local market and acquired Ayrton and Dawanol to give it a presence in west and east Africa.
Overseas acquisitions will be considered to drive future growth. Speaking at the presentation of the financial results, Jonathan Louw, CEO of Adcock, expressed a desire for 30 per cent of the company’s earnings to come from overseas in the future.
This will be supported by Adcock’s in-house distribution network. Adcock claims to be the only South African pharma with its own distribution network and Louw believes keeping this in-house makes it more attractive to international partners.
In particular, Adcock has expertise in handling liquids and cold chain. Upgrades to the company’s regional distribution centers in Durban, Bloemfontein, East London and Cape Town are planned.
Adcock has initiated expansions at its manufacturing sites in Wadeville, Clayville and Aeroton in South Africa and Bangalore, India to boost capacities and capabilities. More than 80 per cent of Adcock’s products are manufactured in South Africa.
The Wadeville site produces pharmaceutical liquids and high potent tablets. A second phase of expansion is nearing completion and a third, focused on increasing capacity, is planned.
Louw added that the site is in the process of gaining approval from the US Food and Drug Administration (FDA) which would help it win business from non-governmental organizations (NGO). Furthermore, it approval will support the export and contract manufacturing businesses.
inVentiv Clinical has expanded its global alliance with the additions of Protech Pharmaservices Corp. (PPC), Ecron Acunova and RDDA. These partnerships will broaden inVentiv Clinical Solutions' clinical research capabilities in Latin America, Asia, Europe and Africa.
PPC, headquartered in Taiwan, has experience across Taiwan, Japan, China, Korea, Hong Kong, Singapore, Malaysia and Australia. The company provides drug development solutions, including Phase I - IV clinical study management, bioavailability/bioequivalence studies, central lab, data management and statistical analysis.
Ecron Acunova, headquartered in Frankfurt, Germany, operates across Europe, Asia and the Americas. The company provides services for Phase I - IV clinical research, including clinical trial management, clinical data management, PK/PD services and central lab for pharma/biotech, nutritional, medical diagnostic and device sponsors.
RDDA, a CRO based in Pretoria, South Africa, provides regulatory, project management and monitoring support across Africa including South Africa, Namibia, Botswana, Zambia, Kenya, Mozambique and Zimbabwe.
"We are very pleased to welcome PPC, Ecron Acunova and RDDA to the inVentiv Clinical Global Alliance, which already includes ActivaCRO in Latin America. The expansion of our alliance is consistent with our mission to help clients accelerate quality clinical research in a cost-effective manner," said Michael Hlinak, president and chief executive officer of inVentiv Clinical. "By forging alliances with these first-class partners, we are better positioned to provide our clients the unique, flexible solutions and unmatched quality they have come to expect from inVentiv Clinical, but on a global scale where it is needed today. Furthermore, this Global Alliance represents significant operational integration and access to rapidly developing clinical research markets."
Videojet has partnered with Systech to help companies meet emerging regulations by introducing track and trace equipment to the Brazilian market.
Last year Brazil implemented a law which requires companies to track the manufacture and consumption of medicines using data capture, storage and electronic transmission technology.
To serve companies faced with this new regulation Videojet is partnering with Systech to introduce the serialized product tracking (STP) system to Brazil.
Explaining the benefits of partnering, Joe Ringwood, chief operating officer of Systech, said: “The combination of Systech's software and Videojet's local support will help meet our customers' immediate serialization initiatives.”
Systech STP allows users to serialize products at the item, case and pallet levels. Information from these items on the packaging line is communicated to the government managed repository. Data also flows the other way, maintaining the integrity needed to meet Brazilian legislation.
Further features include the software’s configurability which allows it to handle the multiple code schemas needed to comply with various regulations, speeds implementation and eases in-house maintenance. These traits decrease downtime, increase productivity and lower costs.
Videojet will use its experience of deploying coding and marking systems in pharma packaging lines to support companies which acquire Systech STP. The company has also been involved in implementing complex hardware and software integrations.
Furthermore, Videojet was a supplier in the pilot program which evaluated the feasibility of complying with the new track and trace regulations.
By combining this local industry knowledge with Systech STP, Andre Santos, Country Manager, Videojet Brazil, believes the company can “offer complete, turnkey solutions that effectively meet manufacturers' business needs”.
BGI will create a $10 million European headquarters in Copenhagen, where it plans to eventually hire up to 150 scientists and support employees.
BGI will recruit between 20 and 50 people during the first year of the Copenhagen HQ — to be called BGI Europe — then establish a sequencing platform allowing for the hiring of between 50 and 100 people. The project will be China's largest investment in Denmark.
The "strong and still growing research community within biotech in Denmark has attracted our attention," Songgang Li, associate director of BGI, said in a statement. "We see some interesting prospects for partnership, and I feel confident that we have acted wisely in selecting Denmark as our European base."
BGI expects to generate DKK 5 billion ($829 million) in first-year revenue from the Copenhagen HQ, according to a statement released by Denmark's Ministry of Foreign Affairs.
Chinese and Danish officials signed an agreement creating BGI's European HQ on May 17, during the Denmark-China Economic & Trade Cooperation Forum held in Copenhagen. The signing ceremony was attended by Denmark's Minister for Economic and Business Affairs Brian Mikkelsen and China's Commerce Minister Chen Deming.
According to the official Chinese government press agency Xinhua, Deming led the largest-ever Chinese trade delegation to visit Denmark, which is China's second largest source of foreign investment. The delegation consisted of more than 100 Chinese entrepreneurs focused on promoting trade and investment with China.
The trade forum was timed to coincide with the 60th anniversary of the establishment of diplomatic relations between China and Denmark, one of the first Western countries to recognize the People's Republic government.
BGI actually announced the creation of BGI Europe six days before the trade forum on May 11, through a pair of one-sentence statements on its website. One statement said the Copenhagen HQ "will offer scientific and technological collaboration and services to the whole European countries, providing R&D in technology and products, [and] seeking out opportunities of cooperative projects in the fields of sequencing and bioinformatics."
The other statement said BGI Europe's priorities include "jointly establishing key laboratories with universities and other research institutes" on the continent.
Founded in 1999 as the Beijing Genomics Institute, BGI is based in Shenzhen. Facilities at BGI Shenzhen include the Sino-Danish Cancer Research Center, opened last year by the institute in cooperation with University of Copenhagen Denmark, Aarhus University, Southern Denmark University and other research institutions. According to BGI, the center uses next-generation sequencing technology for the identification, development, and clinical validation of new biomarkers for early diagnosis of breast cancer.
Denmark is home to more than 130 biotech companies and more than 270 providers of services for the biotech industry, with some 25,000 people employed in the life sciences, Ole Frijs-Madsen, the director of the Danish trade promotion agency Invest in Denmark, said in a statement released by the Danish law firm MAQS, which facilitated the BGI-Danish agreement.
The Irish drugmaking sector well-place to proper despite “challenges” as the pharma industry evolves, according to PharmaChemical Ireland (PCI).
The group, the Irish Business and Employers confederation unit that represents drug and chemicals firms in the country, stressed Ireland’s combined strengths in manufacturing and R&D as key to future prosperity.
Group director Matt Moran said: “Leading international countries are grappling with the challenge of stimulating genuine collaborative initiatives between international and indigenous companies and research centers to develop and commercialize new products and services.
“Ireland’s small size and flexibility is a definite advantage in this regard as it is an ideal development test bed for the global industry to experiment and scale up new product and services.”
Quite how reassured the Irish drug sector will be by the comments, which echo those made by PCI in March , remains to be seen, particularly after Pfizer recently unveiled plans to cut manufacturing capacity in the country.
Nevertheless, the fact that PCI has developed what Moran called a 'factory of the future model’ combining drug R&D and manufacture indicates the industry is at least trying to make Ireland a more attractive destination.
The focus on innovation as a business driver also fits with comments made by the Irish Pharmaceutical Healthcare Association (IPHA).at the recent launch of its Pharmaceutical Healthcare Facts and Figures report for 2010.
IPHA president Gerald Farrell said that: “In order that the industry can play a full role in Ireland’s economic recovery it is crucial that Ireland maintains its reputation as a country that understands and values innovation and the contribution of the pharmaceutical industry.
Farrell called on the government to maintain its current 12.5 per cent corporation tax rate and improve its R&D credit regulations to continue to attract pharmaceutical investment in the country.
Abbott Laboratories has agreed to acquire Piramal’s healthcare solutions unit for an initial $2.12bn (€1.69bn), which it believes will create the largest pharma company in India.
Sanofi-Aventis and Pfizer were both reported to be interested in acquiring the Mumbai, India-based drug maker but Abbott has now entered into a definitive agreement.
Abbott will pay $2.12bn upfront for the unit, plus $400m annually for the next four years. The Piramal unit will become part of Abbott’s newly created, stand-alone established products division.
Piramal’s unit employs more than 5,000 people in India. Abbott currently has more than 2,500 employees across all its businesses in India. The deal follows Abbott’s acquisition of Solvay Pharmaceuticals and recent collaboration with Zydus Cadila.
Invida has acquired a stake in Indonesia-based MUGI, giving it the local manufacturing presence needed to offer partners access to “a vast untapped market”.
Operating a local manufacturing facility allows Invida to hold product licenses in Indonesia on behalf of its partners. This removes the needs for foreign companies to establish their own production sites, providing an alternative way of entering the Indonesia market.
Expanding operations into Indonesia “strongly improves our chance to secure new business” by opening up a new market, said John Graham, CEO of Invida.
Graham added that Indonesia is a “vast untapped market” where growth is being driven by the region’s “burgeoning economic landscape, rising affluence and increased healthcare demand”.
Companies looking to enter this market can now use Invida to procure product licenses and obtain regulatory approvals. Invida is also offering manufacturing, sales and marketing services.
“With the acquisition of MUGI, Invida also further cements its role as a single point of entry for those companies looking for a strategic partner to access Asia Pacific markets”, commented Graham in a press statement.
To gain these capabilities Invida has acquired a 70 per cent stake in Indonesia-based MUGI. Financial details of the deal have not been disclosed.
MUGI operates a production facility in Indonesia where it manufactures dermatological, liquid and oral solid-dose formulations. Invida has stated the site will “undergo a major upgrade” to make it compliant with current good manufacturing practices (cGMP).
This will allow MUGI to offer manufacturing services for a wide range of products, either for local use or export. Invida believes providing manufacturing services for both local and foreign companies could be a significant long-term opportunity for the company and its partners.
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