PHARMACEUTICAL & BIOTECHNOLOGY
WORLD MARKET
UPDATE
March 2013
McIlvaine Company
Holyoke Community College Receives Grant
Rutgers Proposes Facility Upgrades, New Projects
Novartis Vaccines and Diagnostics Gets Award for Facility
Microtest Expands Laboratories for Clinical Trials
Albert Sherman Center, UMMS, United States of America
The Life Sciences Facility, Clemson University, South Carolina
Bactolac Pharmaceutical Facility, New York
Clinical and Translational Research Center, New York
Pharmatek Announces Facility Expansion
Plastikos, Micro Mold Invest $1M in Cleanroom Capacities
Ash Stevens Completes Expansion in 2013
Pulse Systems Expands CNC Machining Capabilities
UFP Technologies Gains ISO Certification at Three Facilities
UL Expands Indiana Medical Device Testing Laboratory
Cytovance® Biologics to Expand
Merck Gets award for Ireland Site
MedImmune Wins Facility of the Year Award for Upgrade
Pharmaceutical Production Line Debuts in Finland
UBC Pharmaceutical Sciences Building, Vancouver, Canada
Sidra Medical and Research Center, Doha, Qatar
South Africa & Lonza Venture Hits Delay on API Facility Construction
Baxter Expands German Cytotoxic Facility
SGS Adds Viral Challenge Testing Facility
Cellular Biomedicine Achieves Cleanroom Certification
MWV Expands Pharmaceutical Manufacturing Center of Excellence
Phillips-Medisize Expands Finland Site
Beximco Starts Shipping Formulations to Europe
PPD Expands Central Lab Services in Brussels, Singapore
Sanofi Invest in Genzyme's Irish Plant
University of Dundee Launches Discovery Center for Infectious Diseases
Patheon Announces Milton Park, UK Expansion
Kemwell Announces Successful USFDA Inspection
Dalton Announces Sterile Filling Expansion Plan
YaFarm Technologies Adds Cleanroom
Lallemand Health Solutions Expands
Gov. Deval Patrick and the Massachusetts Life Sciences Center have announced more than $9 million in grants for life-sciences-related capital projects in western Massachusetts, including $3.8 million to support the creation of a Center for Life Sciences at Holyoke Community College.
HCC was granted $3.8 million to support the renovation of 13,000 sq. ft. of lab space and the creation of a Center for Life Sciences. This will include a cleanroom for the biological sciences, which will be the only cleanroom in western Massachusetts to support training for students, faculty, and industry partners.
"This project at Holyoke Community College is absolutely essential for regional life science economic development," says Steve Richter, president and scientific director of Microtest Labs in Agawam. "The caliber of this project adds to the force required for real change and job development. The focus on microbiology and cleanroom technology creates value for students and industry. The medical device, biotech, and compounding pharmacies will benefit from future graduates."
The Rutgers University Board of Governors has adopted a list of priority facilities projects for the different New Jersey campuses of the university.
Among the proposals is a 57,000 ft2 addition to the Ernest Mario School of Pharmacy in Piscataway, which would include a mock cleanroom, new classrooms, a mock hospital lab, and approximately 8,000 ft2 of wet laboratory space.
Other proposals include the construction of a $115 million building on the Piscataway campus, which would house research labs and teaching areas for the Rutgers Chemistry and Chemical Biology Department; a second Life Sciences Center on the Newark campus, containing teaching laboratories and research facilities; a School of Nursing/Science Building on the Camden campus; an upgrade of the obsolete and inadequate water systems, electrical systems, and the heating and cooling distribution network on the Busch Campus in Piscataway; an expansion of the New Jersey Dental School and the School of Health Related Professions in Newark; and upgrades to the research equipment and technology infrastructure on all campuses.
The projects are contingent upon funding through New Jersey's Higher Education Capital Facilities Program, which include funds from the Building Our Future Bond Act approved by voters in November. The projects, which total more than $410 million in new construction and renovation of academic facilities as well as infrastructure improvements, would create several thousand construction jobs on Rutgers campuses in New Brunswick, Piscataway, Newark, and Camden. The proposed projects include the completion of previously approved renovations of the University of Medicine and Dentistry of New Jersey buildings, which will become part of Rutgers Biomedical and Health Sciences as of July 1, 2013.
Novartis Vaccines and Diagnostics won the Process Innovation award for its US flu cell culture facility in Holly Springs, NC, US. By developing a process based on deep tank mammalian cell technology, several issues associated with traditional egg-based technology have been circumvented. The process offers potential advantages including: process raw materials are readily available and not threatened by pandemic events; and cell culture process uses closed-system bioreactors.
‘The FOYA program is about recognizing the pharmaceutical industry’s innovation and technical advances in facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable supply of quality medications,’ said Chaz Calitri, Vice President of Network Performance at Pfizer and Chairman of the 2013 FOYA judging panel.
‘The six facilities honored by this year’s awards program embody innovation, exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the world right now where outbreaks have occurred, threatening public health.’
The annual FOYA program, now in its 9th year, is sponsored by ISPE, Interphex, and Pharmaceutical Processing magazine.
Morphotek won the award for Sustainability for its pilot plant in Exton, PA, US. The plant supports the manufacturing of advanced therapeutic candidates with either cell culture or microbial systems.
Built on a brownfield site, the plant gives fresh life to a previously contaminated site, which involved soil remediation and demolition of antiquated buildings. Sustainable features also include a modular building envelope system with superior insulation; louvered sunshades, a light shelf to maximize daylight exposure while minimizing interior heat gain; and comprehensive water and energy conservation plans. The implemented HVAC system is 90% more efficient than a traditional building system.
Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.'s Nexvax2® immunotherapeutic vaccine for its expected upcoming clinical trial.
In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.
ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease. Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.
"As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective — and risk-minimizing — alternative to subcontracting with a variety of providers at multiple locations," said Alex Mello, Director of Project Management, Microtest Laboratories. "We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product."
Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services – and a full-range of pharmaceutical testing services – for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials. Microtest fill/finish operations comply with U.S. FDA and European EMA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.
The University of Massachusetts Medical School (UMMS), the U.S., expanded its research and curriculum teaching capabilities with the opening of the new Albert Sherman Center in January 2013. The center is named after the former vice-chancellor of university relations.
The project included a new academic resources building. It added research core space, cleanrooms, wet and dry research space and administration office areas to the Worcester campus of the UMMS.
Expansion of the interdisciplinary, research and education facility has doubled the research capabilities of the UMMS.
"The biomedical research facility project is estimated to cost $405 million. "Construction of the Albert Sherman Center was started in September 2009. The building topped out in February 2011.
Construction of curtain wall façade worth about $20 million, comprising 1,775 panels of glass, terracotta, aluminum and granite materials, began in July 2011.
The project created about 6,000 jobs during construction.
The biomedical research facility project cost $405 million. University of Massachusetts Building Authority is the owner and financier of the project.
The Massachusetts Life Sciences Center funded $90 million towards the development. The new research center is expected to generate about $264 million a year in the Massachusetts state.
The state-of-the-art, nine-storey building spreads over 12,000ft². It accommodates the University of Massachusetts Advanced Therapeutics Cluster (ATC). The ATC integrates the existing research program departments of the university under one roof. It includes the Department of Quantitative Health Sciences, Center for Stem Cell Biology and Regenerative Medicine, Center for Experiential Learning and Simulation, RNA Therapeutics Institute (RTI) and Gene Therapy Center.
The Albert Sherman Center has about 300,000ft² of wet space for research laboratories, core research areas, clean and cold rooms, a vivarium and administrative space.
It also accommodates 200,000ft² of dry research and educational space. It includes a conference center, a 360-seat auditorium, teaching areas, a library, fitness center, support staff areas and café.
It is designed to promote collaboration, interaction and synergy among the life sciences industry, scientists and students of different disciplines.
A 1,600 car parking structure was built at the biotechnology research park. The center is connected to the UMass medical school through a tunnel. The UMass Medical School Albert Sherman Center building is also designed to meet the US Green Building Council's LEED Silver certification.
The Albert Sherman Center utilizes the latest biomedical discoveries to develop therapies and facilitate clinical trials.
"The University of Massachusetts Medical School (UMMS) in the U.S. is expanding its research and curriculum teaching capabilities. "The wet lab is used by the chemists and biologists to develop therapies. The dry lab is used to quantitatively analyze the wet lab outcomes using biostatistics, interactive health outcome assessments, bioinformatics and electronic healthcare data systems.
The ATC researches and develop biological therapeutics for the treatment of diseases such as cancer, infectious diseases, diabetes and neurodegenerative diseases such as Parkinson's and Alzheimer's diseases. It employs about 700 scientific and support staff and 80 new faculty researchers.
They also work on the stem-cell and genetic technologies to cure life-threatening diseases.
RNA Therapeutics Institute (RTI) formulates strategies with RNAi mechanism for gene control. The Gene Therapy Center (GTC) is involved in the R&D of recombinant adeno-associated virus, and The Center for Stem Cell Biology and Regenerative Medicine aims at elucidation of disease mechanisms in humans. The three centers in collaboration are expected to create optimal therapies.
The Massachusetts Medical Device Development Center, Massachusetts Biological Laboratories and Commonwealth Medicine university programs are further expected to translate the ATC therapies to clinical trials.
UMass Building Authority and the UMass Medical School have collaborated in the plan, design, program and construction of the project. ARC/Architectural Resources Cambridge was the architect of the Albert Sherman Center. Suffolk Construction is the general contractor.
PMA Consultants is the project and program manager. Enclos is the façade contractor. The LEED and energy consultant is Fore Solutions. Good Harbor was responsible for design and engineering of security services of the research facility and the car parking structure.
The new life sciences facility at the Clemson University campus in South Carolina was opened in February 2013. The new facility will be the home for the College of Agriculture, Forestry and Life Sciences (CAFLS). It offers sophisticated technology and provides the tools needed to carry out research in various fields at the university.
The new life sciences facility is owned and operated by Clemson University. The investment for the construction of the facility was about $50 million. It was financed through the sale of bonds, which was approved by the South Carolina Budget and Control Board.
"The new facility will be the home for the College of Agriculture, Forestry and Life Sciences (CAFLS). "The new life sciences facility is a three storey building with total a floor area of 100,000ft². It has three microbiology teaching laboratories, 25 research laboratories, as well as preparation space for those labs. It also has a light imaging facility.
The facility will be engaged in research in different disciplines, with a major focus on cancer prevention and cure, emerging pathogens, food safety and microbiology. The microbiology laboratories at the facility will implement new research methods.
The life sciences facility also has space for IT support, display areas and a research activity reception. It can accommodate up to 25 researchers along with their students and technical and service-support staff.
The research carried out at the facility will help in keeping the food supply safe and the environment clean and protected. Key research areas at the facility include biochemistry, microbiology, immunology, endocrinology and proteomics.
The research facilities are expected to encourage students to choose Clemson University undergraduate and graduate level studies.
The new facility is well equipped with latest technology for various clusters of life sciences research.
The equipment provided by Leica Microsystems for the light imaging suite at the facility is very useful for carrying out research in life sciences, as the newest equipment in light microscopy enables researchers to observe life as it happens, and visualize it in still images or live films.
The architectural development for the new facility began in 2006. The site preparation works and construction began in 2008. The construction work was however stopped in autumn 2008 due to the unsteady economic conditions prevailing during that year.
"Key research areas at the facility include biochemistry, microbiology, immunology, endocrinology and proteomics. "The construction resumed again in January 2011. Work on the building's foundation and interior columns began in May 2011. The lower level floor slabs were subsequently poured. The topping-out ceremony of the building was held in September 2011.
The offices within the building are sectioned off with glass walls. The open lab bays of each floor provide a long view. The building is finished with a brick-and-glass exterior.
The architects for the facility were Perkins + Will. The construction contract for the project was awarded to DPR Construction, a company based in Atlanta.
The new life sciences facility was constructed using green building standards. The facility was constructed by adopting environmentally sustainable methods to achieve LEED gold status.
The building was designed to increase energy efficiency by adopting environment-friendly means. The laboratories are infused with natural light and are fitted with overhanging fluorescents to save energy. The building is also fitted with motion sensors, which will cut-off lights when people walk away. It has angled ceilings that are painted in white, which will reduce the need for artificial lighting.
The building's air-intake vents maximize the temperature controls. The rain water will be captured and channeled into the rock gardens, where it will be filtered and purified for use.
Bactolac Pharmaceutical's new manufacturing facility in New York is located alongside its existing facility in Hauppauge. Launched in August 2009, the new facility has doubled Bactolac's total facility space and daily production capacity.
The new facility is a 60,000ft² building certified with good manufacturing practices (GMP). It has doubled the total facility size to 120,000ft².
For over 15 years Bactolac has developed formulas for a host of conditions including weight loss, stress relief, relaxation, sports nutrition, immune improvement, life extension, brain function, energy products, antioxidants and several herbal treatments.
The new facility has strengthened Bactolac's position in the nutritional supplements contract manufacturing industry.
The combined cGMP-compliant facility is equipped with HVAC technology systems that monitor temperature and air quality. It accommodates micro and analytical laboratories as well as production space.
The microlaboratories maintain the purity of products and ensure that the products are free from contaminants. The analytical laboratories develop methods and validate and test products to ensure strict label adherence.
Lab equipment at the facility includes a gas chromatograph, high pressure liquid chromatography, UV spectrophotometers, infrared spectrophotometers, inductive coupled plasma spectrophotometers (ICP-OES), ICH stability chambers, a disintegrator, tablet hardness tester, incubators, autoclaves, bio-safety hoods and a range of instruments to assist in monograph testing.
The dust-contained facility is designed to facilitate easy changeover and quick processing times. It is fully equipped with multiple capabilities such as superior material handling, film and sugar coating and advanced manufacturing skills. There is also an extensive warehousing facility.
Additional equipment within the facility include ergonomic load lifters, high efficiency rotary compression machines, fully automated high speed encapsulation machines, high performance screening and milling machines, and FDA-certified large capacity V and ribbon blenders. It also has automated packaging lines, gravity feeding distribution silos, automatic blister packaging and a large shrink wrap.
The facility develops products based on the nutraceutical formula of each client. Should the client have a concept but not a formula, Bactolac scientists can custom-design a specialized formula that matches the concept.
Once the desired supplement formula is developed and approved, the facility weighs, tests and verifies the product materials in precise quantities.
The material is then sent to a designated blender where it is sequentially added. The blender is then rotated for a specified mixing period.
To ensure that each product is produced in compliance with the standards, formulation analysis is carried out by batch. The vitamin or nutraceutical blend is then prepared in the required dosage form and packaged.
The Bactolac facility produces dietary supplements in powdered, encapsulated and solid dosage forms including capsules and tablets. The facility uses an inventory of more than 5,000 raw ingredients. It produces colored, imprinted, NP, pearl, soft gels and vegetarian capsules; as well as bi-layer, chewable, color-coated, effervescent, enteric-coated, film-coated, imprinted, pharmaceutical glaze, sublingual-coated, sugar-coated and time-release tablets.
The facility develops powders as blends that are used in meal replacement bars, electrolyte drink mix, meal replacement powder combinations, multi-vitamin and mineral blends, green food powders, red berry powder and protein powders.
All products manufactured at the facility can be custom-packaged in blisters, bottles, boxes, colored caps, CRC caps, flip-tops, pouches, shrink wrap, stick packs and jars with induction seal, inserts and labeling.
"The facility compresses 15 million tablets every day."The facility compresses 15 million tablets and coats six million tablets every day. Each day the facility blends 25,000kg of powder and encapsulates six million capsules.
The bottling, powder filling and blister packing capacity of the facility is 100,000 units, 35,000 units and 1,000,000 units per day.
The clinical and translational research center (CTRC) was inaugurated in September 2012. It is located in the University at Buffalo (UB) medical campus in Buffalo, New York.
The CTRC helps researchers engage in translating basic biomedical research discoveries into new treatments. The research center was jointly developed by UB and Kaleida Health.
The new CTRC is located in the ten-storey UB-Kaleida Health building's top portion, between the fifth and eighth floors. The facility has a total floor space of 170,000ft² for research activities.
The new research center has administrative, clinical / translational research training and community engagement offices. It also has a clinical research center, which provides exclusive support to the investigators for carrying out research. It will enable the physician scientists to carry out research on top floors of the building, while they can also work with clinicians in Kaleida's Gates Vascular Institute, which is located downstairs in the same building.
The center is designed to have most sophisticated open-plan laboratories provided with ample research space for more than 20 principal investigators. It also has nine examination rooms for patient observation. It also has support space dedicated for laboratory processing, blood drawing and specimen collection, as well as safe record storage capabilities.
The research center features technically sound infrastructure and is well-equipped with state-of-the-art biorepository and specimen processing laboratory. It has an imaging facility supported with MRI, CT scanner and PET-CT scanner. It has a biosciences incubator with laboratories and office space. It also has an animal research facility.
The CTRC is equipped with a sophisticated hardware data management and sharing system. The research data is assimilated through computational research at the center of excellence in bioinformatics and life sciences.
Construction on the ten-storey UB-Kaleida building was started in August 2009. The foundation works were finished and first steel at the building was erected by February 2010.
UB invested $118m as its share for the construction of the CTRC. The construction of the building continued for a little over three years.
The exterior of the building features a glass box form with curvilinear finishes. The north and south facades of the building were clad with glass and the east and west facades were endowed with shade curtain wall.
The building features an atrium at fifth floor. It also has fibreglass-reinforced wall panels and terrazzo floor tiles. Natural colors such as white metal, concrete and gray are used throughout the building.
Cannon Design was the architect for the UB-Kaleida Health building. The design of the building was completed in two years. Cannon Design also provided mechanical, electrical and structural engineering support for the building, along with DiDonato Associates, who provided civil engineering support. The interior designs were provided by AIA and ASID.
The building construction and management contract was awarded to Turner Construction and LP Ciminelli. Bega, Kim Lighting and Voight Lighting provided the exterior lighting at the building, while the interior lighting system was provided by Edge Lighting, Forum, Kurt Versen, Mark Architectural Lighting, Visa Lighting, Pinnacle Architectural Lighting and Pure Lighting.
The doors were supplied by Algoma. The workstations and seating facilities were provided by Arcadia, Cabot Wrenn, Harter, Herman Miller, Knoll, Krug and Versteel.
The glass for the building was supplied by Archetype Glass, McGrory Glass, Skyline Design and Viracon. The window treatments provided by Colvin Draperies.
The flooring suppliers included Dura-a-flex, Forbo, General Polymers/Sherwin-Williams and Wausau Tile.
The carpet supplies were Lees Carpet, Patcraft-Designweave, Scott Group, Shaw, Ceiling, Armstrong, Ceilings Plus and Decoustics.
Beau Bois provided the architectural woodworking. The hardware suppliers were Best, McKinney, Ortise Locks, Pemko, Rockwood, Sargent and Stanley.
Cogmedix has recently expanded its medical device contract manufacturing facility to add an additional 8,500 ft2. The expansion includes a 400 ft2, Class 10,000 (ISO Class 7) cleanroom with laminar flow hoods for additional sub environment particle control.
The increase in space is accommodating growth in medical device manufacturing, servicing, warehousing, and order fulfillment. There has been a growing demand for manufacturing capabilities to support laser-based medical devices and dental devices.
Cogmedix focuses on complex electro-mechanical devices; assembling, testing, and packaging a variety of sophisticated electronics, sensors, user interfaces, and high-precision mechanical components. The company is an FDA QSR-compliant, ISO 13485-certified contract manufacturer for medical and clinical devices.
A subsidiary of Coghlin Companies Inc., Cogmedix focuses on the production of Class I and Class II medical and clinical devices for the critical care, home healthcare, emergency room, and industrial laboratories markets. The company is located in West Boylston, Mass.
Pharmatek, San Diego, CA, a contract development and manufacturing organization supporting the pharmaceutical industry, announced plans to expand its GMP facilities. The expansion comes at a time when the company is experiencing strong growth and increasing global demand for its services.
Projected for completion in the fourth quarter of 2013, the expansion includes three additional cGMP manufacturing suites, a new automated packaging line and further drug product and cold storage. The packaging line will produce batch sizes up to 10,000 bottles per day.
The new facility is designed to handle highly potent and cytotoxic compounds, control humidity between 20% and 60 percent RH, and includes client manufacturing viewing areas.
"Matched with our recent equipment purchases, the addition of automated packaging and larger suites enables us to handle larger scale clinical trial material productions; providing a higher level of customer service," stated Kevin Rosenthal, director of manufacturing at Pharmatek. "The ability to serve our clients longer, as they advance their compounds down the development pipeline, reduces their overall costs and time-to-clinic." The additional manufacturing space increases Pharmatek's production capacity by 50 percent. A similar sized expansion is planned for 2014 to accommodate expected long-term growth of the company's operations.
"This expansion plays an important role in our continuous efforts to meet our clients' needs and our ongoing efforts to broaden our manufacturing capabilities," said Tim Scott, president of Pharmatek.
"As we move toward becoming a more fully integrated CMO at all phases of the development pipeline, we will continue to invest in new equipment and our facilities."
New Jersey Institute of Technology is one of several partners in University Heights Science Park in Newark. The school, which is making moves to house hundreds more students on campus, saw more than $100 million in research expenditures in FY2011. .
Biotrial S.A., founded in 1989 in Rennes, France, and with other locations in Paris and London, announced the conclusion of its recent acquisition of Warnex Bioanalytical Services in Laval, Quebec, bringing into its fold more than 70 staff, more than 250 validated assays and 25,000 sq. ft. (2,323 sq. m.) of labs and work stations in the Montreal suburb.
"We have been looking for many years to find the right partner to complement our offer with sample analysis so that our customers could benefit from a full package in their process of developing new drugs or generics," said Jean-Marc Gandon, Pharm.D., founder, president and CEO of Biotrial. "Because of its ability to meet the growing needs of the pharmaceutical industry and to use the latest technology Warnex became an obvious choice. Biotrial is committed to continue providing the excellent service and quality of science for which the Montreal site is known, by continuing its investment in the latest state-of-the-art equipment."
A month ago, the company announced another foray onto the continent, as the company announced the purchase (originally completed last fall) of approximately 1.2 acres in University Heights Science Park (UHSP) in Newark, N.J., where it plans to build its North American headquarters.
"To expand in North America, we needed proximity to superior research and medical facilities and to a major transportation center," said Gandon. "We looked at many locations around the world before deciding that Newark and University Heights Science Park best meet the many key requirements and standards we have for conducting our research."
Architecture firm Francis Cauffman has completed the master design plan for the facility and expects to break ground in the spring of 2013. Biotrial is anticipating occupying the building early in 2014.
According to a release from the New Jersey Institute of Technology, Biotrial's arrival in Newark "marks another significant step in the continuing evolution of a mixed-use technology park in the Science Park section of Newark's Central Ward, a strategy to drive economic development for the continued revitalization of the area."
UHSP is a collaborative venture supported by the adjacent education institutions — the University of Medicine and Dentistry of New Jersey (UMDNJ), Rutgers-Newark, NJIT and Essex County College — city, state and federal government, private industry and community groups. Thus far, a total of 351,000 sq. ft. (32,608 sq. m.) of office, research and technology space; a daycare center; and 21 units of owner-occupied housing have been developed within Science Park, and more than 90 incubating companies are located there. The UHSP initiative also developed nearby Science Park High School in partnership with the Newark Public Schools district.
At build-out, the 50 acres (20 hectares) of UHSP will include 1 million sq. ft. (92,900 sq. m.) of technology laboratories and offices, 75,000 sq. ft. (6,968 sq. m.) of technology incubator space, up to 20,000 sq. ft. (1,858 sq. m.) of ancillary support retail, an 800-student technology high school, two blocks of new and rehabilitated housing and a daycare center. The plan will generate $350 million of construction, 5,000 direct and indirect construction jobs, 6,600 direct and indirect permanent jobs with an annual payroll of $275 million, and $4 million in new real estate taxes.
Biotrial manages more than 80 drug trials and studies annually, many within its own facilities that employ more than 250 people across the Atlantic. Its 5,000-sq.-m. (53,821-sq.-ft.) corporate headquarters at Rennes Atalante Science Park employs 200 at a site near the university hospital affiliated with Université Rennes, including a Phase I unit with intensive care monitoring equipment and laboratories for non-clinical in vivo studies. The company's Stell Clinic in Paris comprises 1,000 sq. m. (10,764 sq. ft.) including a Phase I unit on hospital property, and its Biotrial International Ltd. Outpost in London manages international contracts and multinational Phase II-IV studies.
It is anticipated that the Biotrial project in Newark will create 150-200 construction jobs initially and eventually more than 100 permanent healthcare jobs to support the permanent operation. The Science Park leadership praised New Jersey Lt. Governor Kim Guadagno for her assistance in attracting Biotrial to the Park.
"We anticipate Biotrial's new headquarters here will spark a series of collaborations with the pharmaceutical and biotech industries to advance learning, discovery and innovation," said Denise V. Rodgers, MD, interim president of the University of Medicine and Dentistry of New Jersey and vice chair of the Science Park Board of Trustees. "Further, this will focus more attention on Newark, the State and the region as a research center, attracting the best in the biomedical and health sciences and advancing leading edge interventions to improve health outcomes locally and around the world."
"This is a significant milestone for Science Park," said Joel Bloom, president of NJIT and chairman of the Science Park Board of Trustees. "Achieving this commitment from Biotrial continues the momentum for developing a world-class science and technology center in Newark."
NJIT's research expenditures totaled more than $100 million in FY2011. As of August 20, 2012, NJIT had 114 non-provisional patent applications pending, of which 56 are funded by third parties, and 25 provisional patent applications pending. In addition, NJIT has 154 unexpired U.S. patents of which 53 are unlicensed. The remaining 101 are either licensed (84, optioned six) or jointly owned (11 with third parties).
NJIT, which is also making a move to house hundreds more students on campus, is home to the Enterprise Development Centers (EDC), New Jersey's largest high-technology business incubator, and one of the largest in the nation. Ninety companies housed at the EDC employ 800 people. It has attracted more than $67 million in third-party funding and has revenues of $82 million.
Recent New Jersey life sciences news was not limited to Newark. Earlier this month, the New Jersey Economic Development Authority (EDA) announced that it will launch a Life Sciences/Healthcare IT Accelerator at its North Brunswick-based Commercialization Center for Innovative Technologies (CCIT), and secure a private partner to manage the effort. The state's first technology accelerator, TechLaunch, was created by EDA in 2012 with industry pioneer Mario Casabona.
The EDA expected to issue a Request for Proposals in late February via a competitive solicitation that will score and rank the respondents who would like to manage the Accelerator. (Following its issuance, the solicitation will be available at www.njeda.com .) The ranking criteria will include: a demonstration of matching funds and readiness to proceed; strength of historical investment track record; strength of historical role in mentoring entrepreneurial companies; and, experience in the New Jersey life sciences market. Respondents will be required to detail their specific model and approach, along with the justification of why the proposed model will be successful in New Jersey.
Consistent with TechLaunch, the new Accelerator would have the EDA's contribution of equity as "matching dollars," with a ratio of 2:1, thus leveraging private capital and commitment. Under this initiative, EDA would contribute $500,000 of capital, plus an estimated $35,000 of in-kind real estate contribution per year over three years. The cash contribution will require the formal 2:1 private sector match, for an annual public private investment of $1.5 million. The EDA's funding will be in exchange for a $535,000 annual prorata Limited Partnership investment, with a subordinate equity return position.
"Governor Christie recognizes how important it is to nurture the growth of New Jersey's early-stage life sciences and technology companies, and this is another opportunity for the state to partner with the private sector to fill a market need," said EDA Chief Executive Officer Michele Brown. "The Life Sciences/Healthcare IT Accelerator will allow us to capitalize on the talent in our region and provide an environment that catalyzes innovation, entrepreneurship and job creation."
Biotrial maintains its corporate headquarters and central operation at this site in Rennes Atalante Science Park in Brittany, France. The park is growing fast, including a new chemical engineering center scheduled for completion by early 2014 that will accommodate more than 500 people; a new nanotechnology center; and, in November, the opening of a new 550-person technology campus by Technicolor Corp. The 307 companies affiliated with the science park created a net 735 new jobs in 2012 and 761 jobs in 2011.
Plastikos and Micro Mold are investing $1 million in capital expenditures in 2013 to increase cleanroom molding and precision moldmaking capacity.
Plastiko is expanding its cleanroom capacity with the addition of an 88-ton Arburg cleanroom molding press, which will increase its molding capacity by 50 percent. A total of three presses will enable Plastikos to serve the market need among contract molders for Class 10,000 (ISO 7) cleanroom molding.
The company also plans to invest in its whiteroom medical and electronics molding projects, coupled with end-of-arm-tooling robotics. Plastikos is also planning to purchase additional inspection equipment and automated inspection programming.
Plastikos' sister company, Micro Mold, plans to increase the efficiency and quality of tooling production through a sizeable investment in automation and robotics. This will enable the company to provide more 3D EDM work, lights-out operations, and overall efficiency, quality, and capability expansions.
Based in Erie, Pa., Plastikos is a custom injection molder and Micro Mold focuses on medical mold building for small, tight-tolerance components.
Plastics manufacturing company Polymer Corp. has opened a new facility in Palmer, Mass. The building includes a separate cleanroom, as well as five large-capacity 500-to-800-ton injection molding machines.
The plant houses 26 plastic injection molding machines ranging in size from 38 tons to 800 tons, and offers capabilities like overmolding and insert molding. Polymer also provides a range of finishing services, including in-house camo dipping, painting, EMI/RFI shielding, hot stamping, pad printing, and sonic welding.
Polymer specializes in liquid resin cast parts and injection-molded and machined parts and assemblies in low-to-medium volumes for a national base of blue-chip customers. The 92,000 ft2 facility becomes Polymer’s primary base for its injection molding and decorating services business.
"Polymer is rapidly growing and committed to manufacturing in the United States," says Jim Ryan, the company's chief operating officer. "Our new Palmer plant provides needed additional capacity, supports our commitment to innovation through the use of state-of-the-art technology, and allows us to run highly efficient operations. Further, Palmer is convenient to our customers and our workforce."
Ash Stevens Inc. (ASI), a full service contract pharmaceutical manufacturer, is in the final stages of completing a multi-year, multi-million dollar expansion to its cGMP manufacturing facility in Riverview, Michigan. All construction on the project is now complete. The final phase of the expansion involves the commissioning and validation of a new large-scale reactor bay and companion large-scale isolation bay. Validation activities are scheduled to be complete April 2013. The new large-scale reactor bay houses 2,000, 3,000 and 4,000 liter glass-lined vessels equipped with split butterfly valves and appropriate engineering controls for potent compound charging and handling. The new adjacent isolation bay is equipped with a 1.5 m2 fixed filter dryer with glovebox technology for contained isolation, drying, and packaging of large-scale batches. This technology permits handling of potent compounds and air sensitive materials at scale.
“With the completion of the expansion, Ash Stevens will have the capability to meet the service and capacity needs of most projects while still providing close interactive client support and project management to facilitate a successful outsourcing experience. We have come a long way over the past fifty years and are very excited to be completing this latest phase of expansion at our state-of-the-art manufacturing facility in Riverview, Michigan,” says Dr. Stephen Munk, President and CEO of Ash Stevens.
In addition to the large-scale reactor and isolation bays, Ash Stevens has added many other upgrades to its Riverview manufacturing facility since beginning this expansion phase in 2006. These upgrades include: a new hydrogenation reactor bay; a new solid-state characterization laboratory that includes DSC, TGA, XRPD and PSD instrumentation; a new laboratory with appropriate air handling systems for the synthesis of highly potent compounds; a new state-of-the-art materials storage and handling facility; new Rosenmund filter dryers with glovebox technology; and a new safety and hazard assessment laboratory equipped with RC1 technology.
Pulse Systems has recently completed a major expansion of its facilities for precision CNC machining of small custom components for medical devices. These machining capabilities include milling, turning, boring, and drilling of very small features on a range of biocompatible metals. Building on its expertise in laser machining and laser welding, Pulse can provide turn-key ISO 13485 certified sub-assembly services.
Secant Medical Inc., a Perkasie, Pa.-based biomedical textile manufacturer, has established a new laboratory to perform polymer synthesis and analytical characterization of polymers, biomaterials and fibers. The addition gives Secant a more robust set of in-house services for clients and enhances its biomaterials research and development (R&D).
“The study of biomaterials is moving toward examining the interface between materials and biological systems. Our new lab affords us the ability to probe this interface,” said Jeremy Harris, R&D lab manager at Secant Medical.
According to Secant, the lab will offer capabilities including scanning electron microscopy, elemental detection, infrared spectroscopy and imaging, UV/Vis spectrophotometry, melt-flow rheometry, differential scanning calorimetry, thermogravimetric analysis, and light microscopy.
“With this lab, Secant Medical has the tools to develop biomaterials because it gives us a deeper understanding of the interaction of biomaterials, from their composition and interaction with cell biology to how they will ultimately impact device technology,” said Peter Gabriele, director of emerging technology at Secant Medical. “Biomaterials are in themselves an emerging technology. We have to understand how they behave and perform beyond the mechanical analysis—we must understand the chemical analysis.”
The lab is open and fully operational, driven by a team of chemists, chemical engineers, microbiologists and biomaterial engineers. Executives said the facility will help create quality products through material solutions that have a more efficient turnaround time.
Secant Medical designs and manufactures biomedical textiles and other structures for medical devices. The company blends polymeric, metallic, and resorbable biomaterials to create custom, high-performance structures that are used in the cardiovascular, general surgery, neurovascular, orthopedic and regenerative medicine fields.
UFP Technologies, Inc. has been awarded ISO 13485:2003 certification at its Denver, CO, El Paso, TX, and Grand Rapids, MI manufacturing facilities. This certification is awarded to manufacturers that serve the medical device industry by maintaining a quality management system and complying with regulatory requirements, the company said.
UFP Technologies serves the medical industry by designing and manufacturing custom components and specialty packaging from advanced foams, plastics, and films for medical devices, orthopedic implants, wound care applications, infection prevention products and BioPharm solutions.
"We are committed to investing in our operations to become a valuable partner with our customers," says Richard LeSavoy, vice president of manufacturing for UFP Technologies. "Now with seven ISO 13485:2003 certified facilities we are able to grow with and continue to meet the needs of our customers in the medical industry."
UFP Technologies' seven ISO 13485:2003 facilities include: Denver, CO, El Paso, TX, Grand Rapids, MI, Georgetown, MA, Rancho Dominguez, CA, Glendale Heights, IL, and the recently acquired Costa Mesa, CA location (formerly PAC Foam Products).
Quality Tech Services, Inc., a provider of medical device assembly, packaging, and sterilization services, has announced the completion of its Bloomington, Minnesota facility expansion as of January 14th, 2013.
QTS began the expansion of its facility in July 2012 which involved moving into the remaining space of its existing facility, previously occupied by a leasing tenant. The expansion has added 17,000 sq. ft. for a total 54,000 sq. ft. QTS has added another ISO Class 7 cleanroom, as well as additional component cleaning, label printing, and final packaging areas.
The expanded space is now qualified and operational. The expansion will position QTS to keep pace with the tremendous growth of existing customers as well as allow for new opportunities.
“This will enable QTS to serve our present customers and prospective customers, as we continue to expand our services and provide the infrastructure and capacity to successfully meet their needs,” said Doug Wilder, president and CEO.
The South Bend facility will offer non-clinical testing services for the medical device industry.
UL (Underwriters Laboratories), a world leader in advancing safety, announced the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry.
In order to receive regulatory approvals, manufacturers of medical devices and bio-pharmaceutical equipment must demonstrate that their products are safe when interacting with the human body. Depending upon the degree and duration of direct contact with a patient, medical devices must be tested to internationally accepted biocompatibility standards to assess potential biological hazards, chemical and physical properties and interactions with the human body.
Testing to other internationally accepted standards is also performed, such as: basic microbiological testing, virological testing; shelf life of devices and packages; and validation of cleaning, reprocessing and sterilization.
"The expansion of these non-clinical services in North America means that UL is able to support the full spectrum of accredited testing and certification requirements throughout the product development life cycle – from concept to post-market follow-up." said Martha Bonino , Manager of UL's Medical Device Testing services for North America.
In 2011, UL acquired the ISO/IEC 17025 accredited and GLP certified test house MDT (medical device testing GmbH) located in Ochsenhausen, Germany that has operated for over 18 years. MDT specializes in clinical and non-clinical testing services. Leveraging MDT's strength, expertise and innovation, UL was able to expand these services to North America.
Building upon over 20 years of experience in analytical testing, the expansion of our South Bend laboratory enables us to provide value-added test data to confirm both the performance and safety of medical devices.
"With the expansion of the South Bend laboratory, we are now able to provide local non-clinical testing services for the medical industry in both Europe and North America," said Anil Patel, VP & GM of UL's Health Sciences division. "This will fill a key need for companies looking for complete test and knowledge solutions."
GW Plastics, a global manufacturer to OEMs in the medical device and healthcare markets, has completed a 12,000 ft2 cleanroom manufacturing expansion at the company's Tucson, AZ. facility, to support its medical device assembly and packaging business.
The expansion was built to accommodate the re-shoring of two large contract manufacturing programs with healthcare OEMs. A program currently in production at GW Plastics' Dongguan, China facility – consisting of precision molding, assembly, and packaging for a drug delivery device – paved the way for the development of a new application with the same customer. The project will utilize GW Tucson's injection molding capabilities and its assembly and packaging experience. The second large medical device program was relocated from Mexico to take advantage of GW's cleanroom molding, automated assembly, and finished packaging capabilities, including pouching, tray-lidding, rigid and flexible form, fill, and seal (FFS) packaging.
"We are committed to investing in the latest technology to help our customers reduce costs and improve quality through the use of highly automated integrated thermoplastic and liquid silicone molding, assembly and advanced in-house tooling solutions," states Tim Reis, VP of Healthcare Business Development at GW Plastics. "The expansion of our Tucson facility will allow us to offer our customers a standardized, global approach to medical device contract manufacturing."
GW’s capabilities include thermoplastic/silicone injection molding, mold making, and contract assembly operating from six standardized locations worldwide.
Cytovance® Biologics, a leading full-service contract manufacturer of mammalian and microbial biologics, announced that it will expand its current mammalian production capabilities to include a 1,000L SUB bioreactor, a 5,000L stainless steel bioreactor and an automated fill/finish line.
Cytovance Biologics currently specializes in the execution of clinical production of antibody and recombinant protein products derived from cell culture at scales up to 1,000L (w/v) from batch, fed-batch and perfusion processes and microbial production up to the 100L scale. The 1,000L and 5,000L bioreactors will complement the existing manufacturing process trains that include 100L, 500L and 1,000L bioreactors, 100L wave system, 50L and 200L Sartorius subs and a 100L microbial manufacturing train. The new bioreactors will be operational by the end of 2013 or early 2014.
Cytovance currently offers semi-automated aseptic vial fill/finish. With the addition of the Chase-Logeman fill/finish system, the increased capabilities will support vial sizes from 2mL to 100mL, batch sizes ranging from a few hundred vials to 20,000 or more and includes 100% weight check. The automated fill/finish service line will meet all FDA and EU regulatory requirements and is scheduled to be fully operational in the third quarter of 2013.
“To meet market and customer demands, we have decided to expand our capabilities in 2013 with the larger bioreactor and fill/finish automation,” commented Darren Head, Cytovance President & CEO. “The increase in capabilities will allow Cytovance to provide clinical material to key clients as they move though the clinic and into commercial.”
Cytovance continues to provide analytical method development and process development for phase I, II, and III clinical trial materials as well as regulatory expertise to support validation and commercial market launch for therapeutic proteins, recombinant proteins and monoclonal antibodies.
Bend Research Inc. (www.bendresearch.com), a leading independent drug-formulation development and manufacturing company, announced that it has received certification of compliance with European Union (EU) Good Manufacturing Practice (GMP) regulations.
This broad certification, which was granted by Sweden’s Medical Products Agency (MPA), covers Bend Research’s manufacture of clinical pharmaceutical supplies for human consumption and testing of those supplies at the company’s GMP facilities.
“The strategic addition of this certification—combined with new capabilities such as high-potency spray‑drying and future commercial spray‑drying—strengthens Bend Research’s position as a preferred provider for oral solubilized, modified-release, inhalation, and many other dosage forms,” said Rod Ray, Bend Research CEO.
“We knew the EU’s quality standards were stringent, but we were confident that our operations met those high standards and were eager to demonstrate that to our customers,” Ray said.
In 2012, Bend Research produced clinical supplies for 16 clients, 37 chemical compounds and 136 clinical manufacturing lots. Many of these involved the use of advanced dosage forms designed to increase the exposure of low-solubility compounds or provide modified-release delivery profiles.
Bend Research requested the voluntary inspection by the MPA and certification was granted after an audit of operations by the MPA.
The MPA GMP Certificate is recognized by all health authorities in the EU under the EU’s centralized marketing authorization procedure, as well as by authorities of other countries that recognize EU certification.
Bend Research has more than 280 employees based in six state-of-the-art facilities in Bend, OR.
OnCore Manufacturing LLC, a supplier of electronic manufacturing services to medical device OEMs, has opened its medical Center-of-Excellence at its Fremont, Calif. facility. Designed to fulfill medical device design and electronic manufacturing and assembly services, the facility will combine the company’s management of medical product manufacturing and assembly with its medical product design services, all cGMP compliant.
“The state-of-the-art COE facility provides Oraya with our own IP-secure assembly area that’s cleanroom-ready, which when coupled with OnCore’s product transfer process helps us meet our time-to-market date,” says Jim Taylor, CEO of Oraya Therapeutics, which is partnering with OnCore. “We have found OnCore very flexible in meeting Oraya’s changing requirements. This is one of the many attributes we are look for in a partner.”
Oraya Therapeutics Inc. is a privately-held company developing non-invasive therapies for diseases of the eye. The company is based in Newark, CA.
Merck & Co took the Operational Excellence Award for its Vaccine and Biologics Sterile Facility (VBSF) project in Carlow, Ireland. This was Merck’s first green-field sterile processing facility outside the U.S. and from the beginning the project team was committed to employing a Lean Six Sigma philosophy as the foundation for every part of the project.
‘The FOYA program is about recognizing the pharmaceutical industry’s innovation and technical advances in facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable supply of quality medications,’ said Chaz Calitri, Vice President of Network Performance at Pfizer and Chairman of the 2013 FOYA judging panel.
‘The six facilities honored by this year’s awards program embody innovation, exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the world right now where outbreaks have occurred, threatening public health.’
The annual FOYA program, now in its 9th year, is sponsored by ISPE, Interphex, and Pharmaceutical Processing magazine.
MedImmune won the Equipment Innovation award for its UK Automation Upgrade Project in Speke, Liverpool, UK. Faced with the lack of commercially available equipment and the tight timelines for seasonal influenza vaccine manufacturing, the MedImmune team used a system engineering methodology to redesign each discrete processing step into a fully integrated and automated production train. The team made significant innovations to equipment for automated candling, harvesting, isopropyl alcohol (IPA) spray, decap inspection, and isolation. The result was a 15% increase in yield, a 25% reduction in seasonal labor, an 8% reduction in rejects, and a decrease in waste at every stage of the process.
PROMIS Center, a research center focused on the development of methods for analysis and optimization of pharmaceutical processes, has built a continuous processing pharmaceutical production line – the only one of its kind in Europe. The production line was created for R&D purposes, but it also caters to the needs of the pharmaceutical industry, as continuous processing offers possibilities to increase cost-efficiency in pharmaceutical manufacturing.
Based in the city of Kuopio, PROMIS Center is a multidisciplinary research consortium involving the University of Eastern Finland, VTT Technical Research Center of Finland, and Savonia University of Applied Sciences. The new production line is located in the facilities of the University of Eastern Finland, and it can also be used for training purposes in the fields of pharmacy and engineering.
Continuous processing in pharmaceutical manufacturing is a way of making the manufacturing process simpler and faster while reducing the need to perform intermediate and final product analyses. This is possible with the help of modern systems which measure the quality of the sub-processes even in real time.
In continuous processing, the flow of material stays even and there are no pauses in between the manufacturing stages. This assures a more uniform quality of the end product than possible in traditional batch production.
The production line comprises feeders, mixers, conveyors and a tablet machine; however, the core of the production line is built around a roller compactor for dry granulation. The production line also observes the environment, as no solvents are used.
Globally, the pharmaceutical industry is in a serious crisis due to ever lowering marginal profits, and this is why the new manufacturing concept has attracted a lot of attention both in Finland and abroad. The production line serves as a good test bed for the pharmaceutical industry to study what kind of products can and should be manufactured using continuous processing, and what kinds of modifications are required in, e.g., product composition.
PROMIS Center was established in 2008, and each of the research partners has a distinct role in the consortium. The University of Eastern Finland is responsible for R&D related to materials, processes, and manufacturing devices; VTT Technical Research Center of Finland is in charge the development of measurement devices and control systems; and Savonia University of Applied Sciences is responsible for the device integrations needed.
In addition to the research partners, the activities of PROMIS Center have also involved some 20 corporate partners representing the pharmaceutical manufacturing industry, measurement device development, as well as control and modeling sectors.
The University of British Columbia (UBC) constructed a new facility for the Faculty of Pharmaceutical Sciences in Vancouver, in the state of British Columbia in Canada. It has brought together all the learning, teaching, community outreach and research activities of the Faculty under one roof. The building also accommodates the Center for Drug Research and Development (CDRD).
Construction of the Pharmaceutical Sciences Building started in July 2010. The C$133.3m facility was officially opened in September 2012. The Province of British Columbia announced its commitment to contributing C$86.4m for the new facility in September 2009. The remaining amount was funded by the UBC. The project is a sustainable development, built to LEED Gold certification standards of the US Green Building Council.
The new pharmaceutical sciences facility is located adjacent to the UBC Life Sciences Center (LSC), the largest building on the Vancouver campus, which also won LEED Gold certification in 2006. It promotes collaboration across the health disciplines, including life sciences, medical students and researchers.
"The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects."The UBC Pharmaceutical Sciences Building is a six-storey structure with 22,871 square meters (246,091 sq. ft.) of usable space. It includes educational spaces, 14 small case-based specialized learning laboratories, research spaces, classrooms, a lobby, lecture halls, distance learning educational facilities, informal learning spaces, administration and professor's offices, a student lounge, a cafeteria and conference rooms.
The building also has a private multimedia recording room, laboratories equipped with portable tablet computers and a multipurpose lab with remote lab access. An exhibition area, called Story of Medicines, is housed in the public spaces of mezzanine and ground levels. It features interactive screens and historical artifacts to allow the visitors to know about various aspects of pharmacy, such as evolution and life of the drugs.
Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities, in April 2011.
The new facility enables the Faculty of Pharmaceutical Sciences to increase the enrolment of students into graduation and under-graduation programs by 47 percent (72 student spaces) a year. It is expected to have 896 undergraduate students by 2015.
The new building also supports the Doctor of Pharmacy (Pharm.D) and PhD programs. This in turn is expected to cope with the shortage of pharmacists in the British Columbia region.
The UBC pharmaceutical building project generated about 850 jobs during construction. It is easily accessible through public transportation and has several bicycle parking and showering facilities.
"Merck donated about C$250,000 worth of pharmaceutical equipment for use at the current and new facilities in April 2011."The project has not added any new car parking spaces, but promotes sustainable transport options.
The facility has glazed façade and two full-height atria to allow maximum daylight, passive ventilation and maintain temperature of the interiors throughout the year.
Heat from the data center in the basement is recovered to reduce the consumption of energy. An on-site storm water runoff system, efficient irrigation system and 20% less potable water consumption are also planned.
Recycled, local construction materials, low-emitting materials and FSC-certified wood were used to reduce environmental impact. The facility is also designed to increase the lifespan of the building and reduce maintenance costs.
The CDRD is an independent not-for-profit organization launched in 2007. It collaborates with institutions and research universities to reduce the gap between academic discoveries and commercialization of the developed new drugs in laboratories.
The faculty in collaboration with CDRD allows the students to conduct pharmaceutical research and get hands-on experience in an innovative environment.
The organization provides its expertise in technical, scientific and commercial aspects of drug development. It raised about $75m from the government and pharmaceutical companies.
The Pharmaceutical Sciences Building was developed by the UBC Properties Trust. The facility was designed by a joint venture between Saucier + Perrotte Architectes and Hughes Condon Marler Architects.
Ledcor is the general contractor. Glotman Simpson was the structural engineer. Stantec was the mechanical contractor, while Applied Engineering Solutions (AES) was the electrical works contractor. Perry + Associates was the landscape architect.
Located in Doha, Qatar, Sidra Medical and Research Center will be an ultramodern, all-digital academic medical center, designed and planned to the highest international standards in technology, science and patient care. Sidra is currently under development and will be located on the Education City campus, which is owned by the Qatar Foundation.
Announced in June 2004, Sidra represents the vision of Her Highness Sheikha Moza bint Nasser, Chairperson of Sidra and the Qatar Foundation, to create a hospital and research center catering to the needs of women and children in Qatar. The high-tech Sidra facility will not only provide world-class patient care, but will also include medical education and biomedical research facilities. Sidra is funded by a $7.9bn endowment from Qatar Foundation, one of the largest endowments for a medical and research center in the world.
As a premier medical school in Education City, Weill Cornell Medical College in Qatar will be involved in all three of Sidra's missions - patient care, medical education and biomedical research. Sidra will serve as a primary teaching venue for Weill Cornell medical students. It will provide the students with the opportunity to develop and practice their clinical skills with the guidance of experienced Weill Cornell faculty and to conduct scientific research using the ultra-modern technology available at Sidra's state-of-the-art facility.
Sidra will also work in conjunction with Hamad Medical Corporation (HMC), Qatar's public health provider, to ensure that the patient services offered by the two entities are complementary and that, together, they provide the full range of learning opportunities for medical students. HMC will also be involved in biomedical research with Sidra and will house some of the early research efforts until Sidra opens.
"The high-tech Sidra facility will not only provide world-class patient care, but will also include medical education and biomedical research facilities."Sidra will initially have 400 beds and a floor space of over 139,000m² (1.5 million ft²). The academic medical center has three atriums which will focus on children and women's health. An additional Outpatient Clinic building connected to the center at every level will have 37,160m2 (400,000ft2) of space dedicated for ambulatory care.
As of February 2013, the Sidra project team responsible for setting up hospital operations and planning currently has over 240 staff members and will employ over 4,500 clinicians, nurses, allied health professionals and support staff after the hospital opens and becomes fully operational. The center has parking spaces for approximately 1,000 cars for staff and1,000 for the public. The hospital will be expanded to 550 beds in a subsequent phase. The future phase of expansion at the center will also add another ambulatory clinic building.
Sidra Medical and Research Center will be equipped with advanced technology, sophisticated medical equipment and state-of-the-art laboratories for innovative research and clinical advancement. The center will be an all-digital facility with wireless technology, using sophisticated IT applications for clinical, research and business functions.
The center will feature the most advanced technologies available, such as robotics, computer-aided surgery, digital imaging and diagnostics. All work at the hospital and biomedical research centers will be carried out by using paperless and wireless technologies.
Sidra's informatics system, Patient Electronically Accessible Record for Life (PEARL), will ensure instant and seamless access to accurate information at the touch of a button.
The center will have Healthcare Information and Management Systems Society (HIMSS) Analytics Stage 7 designation within months of opening. Sidra's advanced Information Technology solutions will make a significant contribution to the realization of the national e-health strategy of Qatar.
The new medical and research center broke ground for construction in mid 2008. The aim is to equip the Sidra building by the fourth quarter of 2013. Sidra is working closely with its partners to finalize exactly when the Medical and Research Center will be fully operational.
The new medical and research building has three atriums, which will serve as indoor healing gardens, dividing it into three main sections for different services. The atriums are constructed using ceramic tiles, metal panels coated with enamel and glass with stainless steel accents and sunshades. The lobby and other public spaces in the center are being built with natural materials such as wood, granite and marble.
DuBiotech, or the Dubai Biotechnology and Research Park, is a science park development in the city of Dubai.
The architectural design for Sidra Medical and Research Center was provided by Pelli Clarke Pelli, an architecture firm based in the US. The initial clinical planning for the Center was completed in late 2005 and the architectural design was announced in early 2007. A key project milestone, Sidra's schematic design, was completed in the summer of 2008.
The construction contract worth $2.3bn was awarded to a consortium of Obrascon Huarte Lain and Contrack. The space programming contract was awarded to Kurt Salmon Associates. KEO International acts as the construction manager, while Qatar Petroleum / ASTAD are serving as client representative on behalf of Qatar Foundation.
In January 2013 Omnicell, along with its partner Mannai Corporation, was awarded a contract to provide its G4 medical supply platform to the center. The scope of the contract includes providing wireless and virtually paperless nursing and pharmacy operations.
In January 2013, Amcom Software was awarded a contract to provide communication software for the center. The scope of the contract includes providing emergency notification and call center solutions to Sidra.
A South African and Lonza joint project says issues in funding, competitiveness and green technologies have delayed construction of its API plant.
The ZAR1.6bn ($180m) venture, known as Ketlaphela, was set up between South African state-owned chemical producer Pelchem and Swiss contract manufacturer Lonza in order to build the country’s first antiretroviral API (Active Pharmaceutical Ingredient) plant. However, after a year the construction has still not been commissioned.
Dominic Werner, Head of Corporate Communications at Lonza, said the delay is due to “some issues which had to be addressed such as competitive prices, green manufacturing footprint and funding.”
These issues support concerns raised by South Africa’s Director-General of the Department of Science & Technology, Phil Mjwara, who explained in more detail the reasons behind the delay.
Talking with South Africa’s Financial Mail , Mjwara said the lack of clarification of whether the State could compete in price with Indian and Chinese API manufacturers, who currently supply the majority of local drug companies, was a factor in the delay.
Furthermore, he added issues over funding and uncertainty over green technologies – both involving Lonza’s commitment to the project - has led to construction being put back.
As for Lonza’s role in the collaboration, the firm were very cagey about details from the start, denying a South African Government report which stated Lonza would invest $65 million in the project during the discussions and negotiations stage.
Werner said “Lonza’s main part in the collaboration was always to be the technology partner” and, again, did not provide any financial details. He explained that Mjwara, however, need not worry about Lonza’s environmental credentials.
“Lonza brings a great expertise in this area, and successfully applies green technology elements such as maximizing recycling of reagents and solvents, minimum water consumption or the conversion of waste products into usable energy,” said Werner, using Lonza’s Visp plant in Switzerland as an example.
South African resurgence for in-house API manufacture comes as part of a Government initiative to address HIV and AIDS through local production of antiretroviral drugs. It forms part of recent attempts to bolster local drug manufacturing which has seen policies developed by the Government to encourage investment from international companies.
Furthermore, earlier this month, South African drugmaker Aspen Pharmacare signaled its intention to produce its own APIs by showing interest in acquiring MSD’s (Merck and Co’s European wing) manufacturing facility in Oss, The Netherlands.
However, though these two examples may counter a general industry trend of moving to outsourcing , when asked Werner said: “We consider the outsourcing trend to be intact.”
SHL announced plans to expand production facilities in Taiwan. A leader in the field of drug delivery devices such as auto injectors and pen injectors, SHL has continued to invest heavily in facilities, advanced machinery and R&D. With the rapid growth of the biologic injectable market, device suppliers are under pressure to broaden the range of services that they can provide. SHL has responded by making significant capital investments such as the $40m that will be spent this year alone.
CEO Roger Samuelsson commented; "Five years ago I signed a letter of intent with the Taiwan government promising to invest $100m here. We kept our promise and even completed that investment early. Now we will spend another $40m for 2013. Our auto injector business is one of the key drivers to this expansion of this production capacity. Our customers are bringing more biologics to market and SHL is going to ensure that we meet their needs."
This year SHL will invest primarily in molding, material handling, assembly and automation capabilities. Production will be ramped up at several facilities in Taiwan, Taoyuan One and various NanKan sites. Increased capacity will allow SHL the flexibility to provide higher quantities of devices each month. In addition to auto injectors, SHL produces pen injectors, infusors and inhaler systems. The company now has well over 2,200 staff globally and will be hiring several hundred new employees in Taiwan this year.
Baxter International's BioPharma Solutions business is expanding its facility in Halle, Germany with an additional 1,750 square meters (18,830 sq. ft.) at its cytotoxic fill/finish contract manufacturing facility. The expansion allows the company to support early phase drug formulation through commercial scale-up, product launch and lifecycle management.
The facility has been expanding to meet demand for cytotoxic manufacturing, further enhancing Halle's resources to support early phase drug formulation through to commercial scale-up, product launch and lifecycle management. This latest move follows previous capacity expansions in Halle in 2007 and 2011. It will increase the workforce at the plant by approximately 10 percent.
The expansion includes the installation of a new commercial filling line with two freeze dryers, as well as a clinical filling line with an additional freeze dryer. Both will be equipped with an automated loading/unloading, capping and inspection infrastructure. The expansion is scheduled for completion in 2015.
The expansion, which should be completed in 2015, includes the installation of a new commercial filling line with two freeze dryers, as well as a clinical filling line with an additional freeze dryer. Both lines will be equipped with an automated loading/unloading, capping and inspection infrastructure. This expansion will support international manufacturing and regulatory requirements.
Baxter's Halle facility has a range of capabilities including commercial-scale production of cytotoxic emulsions, liposomes and suspensions, as well as a nanoparticle suite equipped with a high-pressure homogeniser. The site is equipped with barrier isolator technology and is claimed to be one of the most advanced facilities for cytotoxic contract manufacturing in the world.
With more than 50 years of experience, the facility's capabilities include lyophilisation; process development; aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; sterile crystallization of cytotoxic active pharmaceutical ingredients, in addition to expertise in the manufacturing of antibody-drug conjugates.
"Cancer incidence is on the rise and cytotoxic therapies continue to be at the center of oncology treatment programs," said Dr. Burkhard Wichert, vice president of manufacturing for Baxter's BioPharma Solutions business. "Through this expansion in Halle, Baxter will continue to support pharmaceutical companies' efforts to address patient needs worldwide."
"We believe in our customers and the patients they serve, which is why we continue to invest in the Halle, Germany facility," said Dr. Wichert. "This expansion and our advanced technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing while increasing the current Halle workforce by approximately 10 percent."
SGS is expanding its Clinical Pharmacology Unit in Antwerp, Belgium with a Viral Challenge Testing facility that will include a 12-bed, biosafety level 2-Q compliant, quarantine facility, allowing the company to conduct highly specialized clinical trials.
The quarantine facility incorporates a negative pressure system, which includes individual compartments for infected volunteers, and a dedicated lab equipped with a flow cabinet, acid cabinet, workspace and workflows to handle specific (viral) cultures using HEPA-filtering and an airlock system. The facility also enables detailed assessment of immune parameters that help identify immunological correlations of infection and illness.
“This unique, European viral challenge testing facility enhances SGS’s service offering for our clients in the fields of infectious disease and vaccine development, allowing clients a chance to improve screening and development of their compounds” said Dr. Steven Ramael, SGS Life Science Services medical director. “Although the model does not necessarily reflect all parameters relevant to community-acquired infection, it does provide for a carefully controlled, systematic, and efficient method in which a number of variables can be controlled or even eliminated, with the subjects continuously monitored in a sequestered environment that minimizes safety risks.”
Cellular Biomedicine Group has achieved both ISO 9001:2008 certification and ISO-14644 cleanroom certification. The company has been accredited the International Standards Organization 9001:2008 certification by internationally recognized quality management system SGS and ISO-14644 cleanroom certification from ENV.
ISO 9001:2008 addresses the requirements for implementing an efficient quality management system. This standard ensures that the organization fulfills and achieves continual improvement of its performance in pursuit of the customers' requirements, applicable regulatory requirements and enhancement of customer satisfaction.
Societe Generale de Surveillance, the agency granting the ISO 9001:2008 certificate is an international inspection, verification, testing, and certification company, recognized as the global benchmark for quality and integrity. The certificate is issued by the American National Accreditation Bureau.
Since 2012, CBMG has maintained an ISO-14644 cleanroom certification from ENV Services Inc. ENV is an ISO-accredited, US-based testing and certification company, certified in "Cleanroom Performance Testing" according to the National Environmental Balancing Bureau. The CBMG Shanghai cleanroom facility undergoes a top-to-bottom yearly calibration and validation from ENV.
Cellular Biomedicine Group Ltd. develops proprietary cell therapies for the treatment of certain degenerative diseases. The company is based in Shanghai, China.
MeadWestvaco Corporation, a global leader in packaging and packaging solutions, announced the expansion of its pharmaceutical manufacturing Center of Excellence, based in Hemer, Germany.
The Center is the core for MWV’s global pharmaceutical dispensing systems manufacturing network. The $7.5 million project includes expanding cleanroom molding and assembly capacity, and the introduction of a state-of-the art logistics system to control the flow of finished goods and components. MWV is making this investment in its Healthcare business based upon the business’s rapid growth, especially in the Preservative-Free packaging market.
"This investment underlines MWV’s position as an innovation leader in healthcare dispensing systems and our commitment to manufacturing high-quality products in the appropriate regulatory environment,” said Sven-Uwe Höhm, vice president & general manager, Medical Plastics Division.
The current Center of Excellence consists of clean rooms for precision injection-molding and high-speed component assembly, R&D Facilities with fluid dispensing, fluid atomization, design optimization and broad material knowledge, and project management support. The Center includes further Customer Service, Technical Laboratory and Regulatory teams. MWV’s healthcare products are manufactured according to ISO 9001, Quality Management System for Medical Devices ISO13485, GMP ISO15378 and 93/42/EEC Annex 5 Medical Device Directive standards.
The facility expansion will commence in early 2013 and is expected to finish by the end of the year.
Learn more at www.mwv.com
Phillips-Medisize Corp. announces an expansion to their Kontiolahti, Finland site. The facility produces drug delivery devices such as inhalers, injection pens, and safety syringes.
The 60,000 ft2 expansion will include 12,000 ft2 of new cleanroom space, as well as space for additional warehouse capacity, materials and technical space, new production support, and expanded offices, locker rooms, and metrology space.
This capacity addition is expected to be online by August 2013 and will increase molding and assembly capabilities at the site. Staffing will also be increased by over 15% during the next two years.
Phillips-Medisize is a global outsource provider of design and manufacturing services to the medical device and diagnostics, drug delivery, and commercial markets. The company is headquartered in Hudson, Wisc.
Generic drug manufacturer Beximco Pharma has had European GMP (Good Manufacturing Practice) accreditation since July 2011 but has only just commenced exporting to Europe with Germany and Austria being the first receivers of the formulations latanoprost and timolol.
Spokesman for Beximco, Wasir Heider, said the company’s first venture into Europe comes after 18 months of preparation, securing orders and upping product capacity.
“All Europe is our target,” said Heider who explained that the first import deal with Beximco’s German and Austrian clients – details of whom cannot be divulged - would open the doors to the rest of the continent.
Latanoprost is a drug which reduces intraocular pressure in sufferers of glaucoma or ocular hypertension and is a generic form of Pfizer’s Xalatan which lost its patent in March 2011, as did Pfizer’s Xalacom – an eyedrop containing both latanoprost and timolol.
Since the patents expired, there have been several companies who have manufactured generic versions of Xalatan in the US and Europe including Mylan Pharmaceuticals, Actavis Pharma, Bausch + Lomb and Apotex.
Beximco has stated its intentions of launching additional products in the EU later this year.
Europe is not the first sign of global expansion for Beximco, nor is it the last as the Bangladeshi firm has been busy ensuring international markets and will soon turn its eye on the U.S.
In 2008 Beximco received export approval from the Ministry of Health of Gulf Cooperation Council (GCC) countries, becoming the first Bangladeshi company to enter the market and, in the same year, it became the first Bangladeshi pharmaceutical company to enter Latin America, penning a supply deal with the Drug Regulatory authority in Chile.
The following year Beximco achieved GMP certification from the National Health Surveillance Agency of Brazil – another Bangladeshi first.
A deal has also been inked with U.S. company Adamis Pharmaceuticals in 2010 in which the two companies would launch several generics in the U.S. market and co-develop certain drugs together.
According to Heider, the Adamis deal is “still in the preparation phase”, awaiting accreditation from the FDA (U.S. Food and Drug Administration), scheduled for the end of this year before taking on the U.S. market.
Nazmul Hassan, Managing Director of Beximco in a release for stockmarketwire.com added: "The company is increasingly focused on penetrating large and highly regulated markets, such as the EU and U.S., where the demand for generic products continues to rise.”
PPD has expanded its central lab testing services at its Brussels and Singapore labs and will offer additional services in microbiology, peripheral blood mononuclear cell and molecular pathology services.
The reason for the expansion “is twofold,” said Elena Logan, senior vice president of central labs for PPD. “First, we had built out those capabilities in the US, which generated significant demand from clients in other regions of the world with microbiology needs.
“Second, based on our strong franchise in infectious diseases—which is among the top three therapeutic areas in terms of the industry pipeline—coupled with the fact that more clients want an integrated solution that combines clinical trial management with central labs services, we made the strategic decision to provide a comprehensive solution to our clients who want a full-service outsourcing model.”
Like its US facility in Highland Heights, Ky., PPD’s labs in Brussels and Singapore now offer microbiology testing services for bacteriology, mycology, parasitology and microbioterrorism pathogens.
All three labs can conduct virology testing, including real-time polymerase chain reaction, viral load, genotyping and SNP analysis. They also have the capability to culture, quantitate, identify and determine antibiotic susceptibility and resistance for aerobic and anaerobic organisms.
The company’s lab in China is the only one that has yet to expand to this type of capacity.
The North Carolina-based contract research organization (CRO) is “continually evaluating industry trends to determine how we can best support our client’s needs by offering the majority of testing in house,” Logan said.
“As a result, we have been strategically expanding our capabilities in all of our central labs in Belgium, China, Singapore and the US.”
PPD has conducted nearly 240 studies on infectious diseases over the past five years and the company’s central labs have handled about 50 of these studies.
“These new capabilities are significant enhancements to the broad portfolio of scientific and clinical expertise that we bring to the development of infectious disease products on behalf of our clients,” added Carol Olson, executive medical director and PPD’s therapeutic area head for infectious diseases.
The expansion comes as PPD has added three new therapeutic department heads. Daniel Burch, now heads the division on central nervous system; Puneet Mohan heads cardiovascular /metabolism and Alan M. Solinger heads the rheumatology/immunology sector.
Despite the expansions and new hires, both S&P and Moody’s downgraded their ratings of PPD in October 2012 as the company decided to issue $500m to fund a sponsor dividend.
Genzyme says it will produce the insulin drug Lantus for Sanofi following a second investment in its Irish facility.
The Waterford, Ireland plant was acquired as part of the Sanofi’s purchase of Genzyme in 2011 and the outlay of €44m comes just over a year after a €150m was invested in the manufacturing facility.
The news comes as a boost to both Genzyme and Ireland as a whole, according to Genzyme spokesman Michael Bance who said that after several big pullouts from Ireland by Big Pharma companies, this second investment is extremely encouraging.
Bance echoes Dominic Carolan, Managing Director of Genzyme Ireland, who said in a press release that this was “evidence of Sanofi’s commitment to the location and the confidence that exists in what Waterford can deliver.”
The decision to make Lantus at Genzyme's plant is good news for Ireland's manufacturing sector, which has seen a number of Big Pharma cutbacks in recent years.
Amgen was one of the first to make cuts, closing its manufacturing base in 2007, Abbott did the same in Galway and, more recently, Pfizer cut 177 jobs at its Irish API facility.
In contrast, Sanofi's investment will create 100 jobs at the plant at preparations are made for commercial production, which is scheduled to begin in 2016.
Genzyme's plant will join Sanofi’s Frankfurt facility in the production of Lantus, and this will be the first of Sanofi’s own drugs to be produced by Genzyme.
Lantus is a slow release subcutaneous insulin drug for controlling blood-sugar levels in diabetics.
A specialized center focusing on the development of drugs for infectious diseases commonly found in developing countries, such as tuberculosis (TB) and malaria, is to be set up by The University of Dundee in Scotland, UK.
By establishing 'A Center of Excellence for Lead Optimization for Diseases of the Developing World at the Drug Discovery Unit (DDU), the university will address the urgent need for drug treatment for infectious diseases such as African sleeping sickness, tuberculosis and malaria, which kill thousands each year.
Researchers at the center will address the shortage of potential drugs making it to the lead optimization stage of molecules targeting these diseases.
This is a labor intensive but key stage in the drug discovery process, where early leads are improved through cycles of design, synthesis and testing to identify potential drugs that are suitable for testing in a clinical setting.
Funded by Wellcome Trust and the Bill & Melinda Gates Foundation, with a £6.5m investment over five years, the new center will create 11 jobs.
University of Dundee researcher Professor Paul Wyatt said; "One of the main aims of the Drug Discovery Unit is to make inroads into developing drugs for diseases that affected the developing world. We have the capability through the DDU to help break the bottleneck which occurs at a key stage of the drug discovery process."
TB, the world's second-leading infectious killer, will be the initial focus for researchers.
They will identify a portfolio of TB Lead Optimization projects through the DDU's involvement with the global HIT-TB consortium and TB Drug Accelerator Program, and will identify and optimize multiple series of related TB-killing compounds that could be taken up by the team.
TB disproportionately affects developing countries; in 2010 it caused 1.4m deaths, 8.8m new infections and 450,000 drug-resistant TB cases.
The long-term treatment regimen currently used for TB contributes to high treatment default rates, which can lead to increased disease transmission, drug resistance and death.
Wellcome Trust business development head Dr Richard Seabrook said; "We are pleased to be co-funding with the Bill & Melinda Gates Foundation on this exciting UK project, bringing together internationally renowned experts in the biology of infectious diseases with a first-class drug discovery unit to tackle some of the world's most profound medical needs."
Patheon Inc., a leading provider of contract development and commercial manufacturing services to the global pharmaceutical industry, announced plans for additional investment in its Milton Park facility. Located in Oxfordshire, UK, Milton Park is a dedicated pharmaceutical development services facility focused on early development projects.
As part of its early stage offerings, Milton Park currently provides proof-of-concept and first-in-man development programs for oral dose forms. It also offers Quick to Clinic™, which provides clinical trial materials as fast as four months from receipt of active pharmaceutical ingredient (API). This service has been structured to provide support to emerging pharmaceutical companies with promising molecules.
With the first phase of additional investment to Patheon’s Milton Park facility, the company will be able to expand upon the early development capabilities currently being offered, including the introduction of the SoluPath™ program. SoluPath™ is the first fixed-price, multi-platform solution to improve bioavailability that allows parallel formulation screening using multiple leading edge technologies to review aqueous, lipid-based and solid state formulations. The result is a unique formulation development program for low solubility/bioavailability molecules, which should facilitate a faster route to the clinic. The purchase of a new HME screening tool and spray–drier will supplement existing technologies at Milton Park to provide the SoluPath™ service to emerging pharmaceutical companies with poorly soluble molecules.
“The introduction of Solupath™ into Milton Park’s existing capabilities is an exciting addition to Patheon’s service offering in Europe,” said Robin Platt, Senior Director, Operations for Milton Park. “Poorly soluble compounds are increasingly common in pharmaceutical development and we believe Solupath™ provides a mechanism for identifying the most effective way of improving bioavailability of molecule in these cases.”
Paul Garofolo, Executive Vice President, Global PDS Operations, added, “Solupath™ has been operating successfully in Patheon’s North American facilities. Establishing this capability in Europe is part of Patheon’s global strategy to expand early pharmaceutical development services for our customers.”
For more information visit http://www.patheon.com
KEMWELL BIOPHARMA PVT LTD, a global pharmaceutical contract development and manufacturing company, announced that its Oral Solids manufacturing facility located in Bangalore, India has successfully completed a U.S. Food and Drug Administration (USFDA) inspection.
The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by a NDA filing by one of the top ten global pharmaceutical companies. The audit involved an in-depth review and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the Bangalore site.
“The approval from the US FDA confirms Kemwell’s cGMP manufacturing capability and regulatory compliance, and our commitment to provide our customers the highest standards of quality. The facility has been approved by many global regulatory authorities including EMA, MHRA, Health Canada and TGA. We will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations” says Anurag Bagaria, Chairman and Managing Director.
Applying Quality by Design (QbD) principles, Kemwell’s R&D and manufacturing teams in conjunction with the customer, optimized tablet formulation, conducted process scale-up studies to define design space for manufacturing of tablet formulation, and manufactured the validation and submission batches for this NDA filing.
The state-of-the-art facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has been built in with high flexibility to manage batch sizes from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe and Australia from this facility, and will now soon start commercial supplies to Canada and U.S.
Kemwell Biopharma Pvt Ltd headquartered in Bangalore, India is a pure-play global contract development and manufacturing company. The company manufactures pharmaceuticals for some of the world’s top pharmaceutical companies, including GlaxoSmithKline, Bayer, Johnson & Johnson, Novartis and Pfizer. Kemwell is one of India’s largest contract manufacturers of pharmaceuticals with over 30 years’ experience. The company employs more than 1000 employees worldwide and has seven production facilities, five in India and two in Sweden. Kemwell is an approved pharmaceutical manufacturer in over 80 countries including the American, European, Japanese and Indian markets.
Dalton Pharma Services, a leading provider of drug discovery, development and manufacturing services to pharmaceutical and biotechnology companies, announced that the company has begun the first stage of its strategic aseptic filling expansion plan. The initial stage, which commenced in January 2013, will add high speed sterile vial processing and washing, an upgraded high purity water system, expanded vial depyrogenation capability, additional lyophilisation capacity and automated vial inspection capability. This phase will also upgrade our personnel access with expanded and improved gowning areas.
The upgraded GMP sterile manufacturing capabilities provide Dalton with an ability to handle larger volume commercial aseptic filling of sterile liquids and sterile powders as well as improve project timelines by eliminating bottlenecks. The new space is being constructed within the existing building footprint.
Later stages of the sterile processing expansion plan will add additional GMP manufacturing facilities, equipment and automation that align with Dalton’s goal of providing fully integrated sterile manufacturing services from preclinical to commercial production, for both sterile API and finished doses.
”The expansion of our sterile liquid and sterile powder filling capabilities is in response to the requirements of our customers," said Peter Pekos, CEO of Dalton. “These upgraded capabilities not only increase our overall capacity but allow us to offer more complete and efficient sterile manufacturing services. This will allow Dalton to provide more cost effective and flexible support for our client’s aseptic drug development and manufacturing requirements. Future stages of this expansion will add high-value capabilities supporting large and small molecule development, in line with the evolving needs of the sterile manufacturing marketplace.”
YaFarm Technologies Inc. announces that the Integrative Stem Cell Institute (ISCI), a provider of point-of-care, stem cell- based therapies, is initiating design and development of a new cell processing and culture laboratory in Cancun, Mexico. The Institute has begun construction of a Class 10,000, ISO 7 cleanroom for the processing of autologous, mesenchymal cells for point-of-care therapies.
"This lab is critical for the Institute," says Juan Castillo-Plaza, MD, founder of the ISCI. "As part of our commitment to patient safety, and our on-going clinical studies and research, we will be able to draw, process and then inject the patient's cells within the same facility."
The ISCI lab is part of a 2,000 sq. ft. facility that is housed in the Hospital Galenia in Cancun. "This will be one of the most advanced laboratories in world," says Castillo. The ISCI has brought in experts from around the world to both design the layout of the laboratory space as well as develop standard operating procedures to assure proper standards for quality assurance and quality control.
An essential element of the laboratory's design is the development of an innovative Cell Processing Program (CPP) to define the function and management of the facility. This process identifies specific processes for the selection, sorting and the differentiation of autologous progenitor cells, as well as the long-term cryo-preservation of these repair cells. The CPP has a vigorous quality assurance program built into it with on-going validation procedures, continuous quality control mechanisms, as well as robust record management and data storage systems.
The ISCI believes that the design and construction of this category of laboratory space within a hospital setting is critical for the continued advancement of the field of regenerative medicine. "And we are pleased to have this state-of-the-art facility in a hospital with the stature and quality as Hospital Galenia," says Castillo. "It is the only hospital in Mexico that is accredited by both the Joint Commission International and Accreditation Canada International."
Lallemand, a Canadian manufacturer of yeast and bacteria, has established a new division called Lallemand Health Solutions to provide probiotic solutions to the pharmaceutical and food supplement sectors.
The new division, headquartered in Montreal, will consolidate the probiotic manufacturers Institut Rosell and Harmonium International, which have extensive experience in the selection, development, production and marketing of probiotic strains and formulations that support human health and well-being. It aims to be a one-stop shop for the provision of probiotic products manufactured in cGMP and ISO 9001 environments.
The new division will be managed by Francine Mondou, former co-founder and president of Harmonium International and will cover more than 30 countries across 5 continents.
LHS will offer probiotic formulations such as Lacidofil, Probio’Kid, Probio’Stick and Protecflor. The company will also produce custom formulations based on the Rosell, Lafti or Harmonium strains. All formulations can be delivered in bulk powder or finished product formats such as: capsules, tablets, sachets, sticks, and bottles. They target the gastrointestinal health, immunity, women’s healthcare and stress and anxiety treatment areas.
Institut Rosell was founded by microbiologists Dr Rosell and Dr Edouard Brochu in 1934 in Montreal and is a pioneer of probiotics development in North America. Lallemand acquired the company in 1998.
Harmonium International was created in 1998 in Montreal and incorporated into Lallemand in 2011.
UAE-based pharmaceuticals manufacturer Julphar has inaugurated its first manufacturing facility in Africa in Ethiopia, in conjunction with Medtech, its local Ethiopian partner.
The Julphar Ethiopia manufacturing facility marks a significant milestone in the company's history and is a major part of its international expansion strategy. Once fully operational, each year the cGMP compliant facility will produce 25 million bottles of suspension and syrup, 500 million tablets and 200 million capsules.
The 40,000ft2 (3,716m2) plant located in the Gerji Jakros region of Addis Ababa is equipped with state-of-the-art technology enabling production of Julphar products for the local market and the African continent. Julphar has invested 170 million birrs (approximately US$46m; €34m) in the construction of the plant.
Julphar is a real showcase for other companies looking to invest into Ethiopia.
Recruitment of 50 local staff is currently underway across quality assurance, quality control, production and maintenance, regulatory affairs and various administrative roles. Further and ongoing recruitment will occur as the plant becomes fully operational.
The pharmaceutical market in Africa is significant and growing, with recent estimates set at between US$8–$10 billion.
Dr Tedros Adhanom, Foreign Affairs Minister of Ethiopia, said: ‘Julphar is a real showcase for other companies looking to invest into Ethiopia. From the start, this project fascinated me. Expansion of the facility was factored into the plans from the beginning and for that we are grateful.
‘We also commend Julphar for bringing international standards to their facility. We hope this facility will strengthen the relationship between our countries even further and hope this will bring future investment from the UAE.’
HE Hailemariam Desalegn, Prime Minister of Ethiopia, added: ‘Ethiopia is one of the fastest growing economies in the world, with a growing population. It is important to have tremendous access to quality medicine. I would like to express my appreciation of this project and congratulate HH Sheikh Faisal bin Saqr Al Qasimi for the completion of this project. You can count on government support. Our doors are always open.’
Dr Ayman Sahli, Julphar's CEO, said: ‘Julphar recognizes that Ethiopia is an extremely interesting, dynamic and important market opportunity. As business and commerce across the continent continue to grow along with an increasing population, the demand for quality, affordable healthcare is greater than ever.
‘Ethiopia's strategic position within Africa made it an obvious choice for Julphar when it was looking at opportunities to develop a real and tangible presence in this vast continent.’
Julphar has a diverse portfolio of products targeting major therapeutic segments, including cardiovascular, diabetes, gynecology and other consumer products.
Bayer HealthCare initiated and will coordinate a newly founded pan-European consortium called the European Lead Factory, which has been launched to enhance early drug discovery to address the need for innovative drugs.
The new €196 million, five-year project will create a small molecule library collection allowing drug discovery on innovative and promising targets from pharma companies and academia.
Bayer HealthCare and six other pharmaceutical companies, all members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), will collectively contribute at least 300,000 substances to the European Lead Factory initiative. Bayer alone will provide about 50,000 compounds and its expertise in early drug discovery.
Academia and Small and Medium Enterprises (SMEs) will also jointly develop a library of around 200,000 compounds in the course of the new initiative.
The chemistry part of the consortium consists of 5 SMEs: Sygnature Discovery (UK); Syncom and Mercachem (Netherlands); Edelris (France); and Taros Chemicals (Germany).
This initiative has the potential to be transformational for drug discovery in Europe
The two libraries will form a Joint European Compound Collection consisting of up to 500,000 compounds that will be accessible to the project partners, public organizations and SMEs who are invited to introduce promising new targets for pharmacological screening. Target proposals will be selected through competitive calls. Thus, drug discovery using the Joint European Compound Collection will be performed on proposed targets from pharma companies as well as targets sourced from the public domain.
An equally important part of the European Lead Factory will be setting up a European Screening Center with compound logistics and High Throughput Screening (HTS) facilities, which will be located in Scotland and The Netherlands respectively. The highly automated process will allow researchers to screen the Joint European Compound Collection for molecules that could be a promising starting point in the development of new drugs.
Dr Simon Hirst, Chief Executive of Sygnature Discovery, said: ‘This initiative has the potential to be transformational for drug discovery in Europe and should create a new engine for modern discovery. Long-term benefits will hopefully include improved medicines and a strong industrial-academic network with unique expertise.’
The consortium is a public-private partnership supported by Europe’s Innovative Medicines Initiative (IMI).
Of the total budget, €80 million comes from the European Commission’s Seventh Framework Program for Research (FP7), and €91 million is provided as in-kind contributions from the participating companies that are members of the EFPIA. The remaining €25 million comes from other contributions from the non-EFPIA participants.
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