11/8/2011
Gateway Analytical Growth Demands Move to a Larger Facility
Gateway Analytical recently announced the company will move to a larger facility at
“We are excited about the growth we’ve seen throughout the past year, as it means that we can continue to bring in new business and jobs to the
The new 8,000-sq-ft facility will provide room for additional office space and allow the consolidation of Gateway Analytical’s ISO- and GMP-compliant testing laboratories. It will also house a new wet chemistry laboratory, a chemical imaging laboratory, class 5 and class 100 sample preparation areas, and additional labs for microscopy and spectroscopy equipment.
Quality will be a crucial focus during the move, and will help to ensure there will be no interruption of service to the company’s customers and continued adherence to Gateway Analytical’s quality commitment.
Gateway Analytical, LLC provides solution-driven analytical testing and consulting services to businesses in the pharmaceutical, materials science, and forensics industries. A trusted voice in product efficacy and quality, the Gibsonia, PA, company offers conventional and innovative analytical testing techniques that give clients a competitive edge in the marketplace. Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.
Evonik Acquires Pharmaceuticals Business of SurModics
Evonik Industries AG recently announced it has reached an agreement to acquire the Pharmaceuticals business of SurModics, Inc. headquartered in
“Evonik is a strategic partner and one of the world’s leading solution providers to the pharmaceutical industry. By acquiring the polymer and formulation services businesses of SurModics, we continue to expand our position in this important market”, said Dr. Klaus Engel, Chairman of Evonik’s Executive Board.
SurModics Pharmaceuticals, Inc., an affiliate of SurModics, Inc., is a leader in injectable drug delivery systems. The new business includes two world-class facilities for the development and manufacturing of polymers and drug delivery systems. The company is located in
“With the Lakeshore Biomaterials portfolio of polymers and associated range of established formulation development services, we acquire leading expertise and capabilities for the development and manufacturing of innovative drug delivery solutions. This is a consistent extension of our current pharmaceutical product and service platform,” added Dr. Jean-Luc Herbeaux, Head of the Health Care business at Evonik.
SurModics Pharmaceuticals designs and produces bioresorbable polymers (marketed under the brand Lakeshore Biomaterials) and possesses expertise and facilities to carry out all phases of pharmaceutical product development up to commercial manufacturing. The business focuses on the development of injectable drug delivery systems that systemically or locally release APIs within a period of up to several months. Formulation approaches include bioresorbable mi
With its Pharma Polymers product line, Evonik is a leading developer and producer of functional pharmaceutical excipients. Based on its well-known EUDRAGIT product portfolio, the company develops coatings and matrix systems that provide controlled release of APIs in tablets and other oral dosage forms. In March 2011, this oral drug delivery platform was complemented with the addition of the RESOMER polymers, which are used for controlled-release injectables and bioresorbable implants as well as in medical devices.
Evonik is one of the world leaders in specialty chemicals. Its activities focus on the key megatrends health, nutrition, resource efficiency, and globalization. In 2010, about 80% of the Group’s chemicals sales came from activities where it ranks among the market leaders. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
CoreRx Adds Precision Powder Microdosing System to its Development Capabilities
CoreRx recently announced it has further enhanced its offering by adding an Xcelodose precision powder microdosing system to its Product Development capabilities in response to client requirements for preclinical and early phase clinical GMP supply. The Xcelodose decreases processing time and API use, generating significant cost savings to clients.
For simple formulations of API or powder-in-capsule, the Xcelodose system can significantly reduce processing time and API usage resulting in cost savings when compared to hand-filling options.
“CoreRx is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times,” said Mark Licarde, CoreRx’s VP of Manufacturing. “While CoreRx has always offered API in capsule, we now see examples of some clients maintaining this approach through to Phase II studies in an attempt to compress their overall development timelines, requiring significant quantities of capsules for which an automated solution is best. CoreRx is the only CRO in the world with a full set of Xcelodose change parts all the way down to size 9.”
The Xcelodose system, manufactured by Capsugel, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or API directly into capsules with a high level of accuracy. The Xcelodose system can dispense amounts as low as 100 micrograms and up to 100 milligrams and beyond, into capsules from size 00 to size 9. Dosing directly into capsules can reduce the amount of API required. Additionally, the unit minimizes overall development time by simplifying analytical and stability protocols.
CoreRx focuses on supporting and streamlining the drug development process for biotechnology and pharmaceutical innovators by offering services such as preformulation/formulation development, analytical development, clinical manufacturing, and validation engineering. It has a proven track record and extensive expertise providing comprehensive drug development services to biotechnology and pharmaceutical companies worldwide. CoreRx, Inc. is a CGMP-compliant contract development and manufacturing facility. From its inception in 2006, CoreRx has been dedicated to solving scientific problems and providing expert pharmaceutical services to businesses required to meet the growing demand of pharmaceutical companies.
Headquartered in
GSK to Use Alnylam Pharmaceuticals’ RNAi Technology for Vaccine Production
Alnylam Pharmaceuticals, Inc. recently announced it has formed a collaboration with GSK focused on Alnylam’s VaxiRNA technology for certain GSK vaccine products, including influenza. VaxiRNA is a new RNAi technology for the enhanced production of viruses used in the manufacture of vaccine products. GSK, a leading vaccine manufacturer, is the first company to form a collaboration accessing this new platform.
“At Alnylam, we continue to pioneer innovative opportunities for our RNAi platform that could have transformative impact in medicine and the biopharmaceutical industry. This is exemplified with VaxiRNA, where siRNA technology is being used to increase virus titers in the production of vaccine products. Because production of vaccines can be limiting for the scale and speed of global immunization against many pathogens, including influenza, we believe VaxiRNA can become an enabling technology for the broader vaccine industry,” said John Maraganore, PhD, CEO of Alnylam. “As we advance our VaxiRNA effort, we are excited to form a new collaboration with GSK, a global leader and innovator in vaccine development and manufacturing. With GSK, we aim to apply VaxiRNA technology to enhance influenza vaccine production in cell culture, where Alnylam will receive research funding, in addition to potential milestones and payments on unit sales of commercialized vaccine product.”
Alnylam’s VaxiRNA platform applies siRNAs for the silencing of specific genes that limit or prevent efficient growth of viruses in vaccine manufacturing systems, including those in cell culture and also in eggs. The VaxiRNA platform stems from work Alnylam has performed as part of its Alnylam Biotherapeutics efforts, where RNAi technology has been applied to improve the manufacture of biotherapeutic products, such as recombinant proteins and monoclonal antibodies. This new platform addresses the significant unmet commercial need for innovative technologies that can improve the manufacture of vaccine products, especially where vaccine production is a limiting factor for the scale and speed of global immunization needs.
The GSK collaboration is focused initially on influenza vaccine production in cell culture systems. Under the terms of the agreement, GSK will provide funding and certain milestone payments to Alnylam. If successfully applied in the manufacture of commercial product, Alnylam will receive payments on unit product sales. In addition, GSK has obtained an option for VaxiRNA applications toward two additional vaccine products.
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNAi. The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-PCS for the treatment of severe hypercholesterolemia, ALN-HPN for the treatment of refractory anemia, and ALN-APC for the treatment of hemophilia. As part of its Alnylam 5×15 strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in advanced stages of clinical development by the end of 2015.
Alnylam has additional partner-based programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection, ALN-VSP for the treatment of liver cancers, and ALN-HTT for the treatment of Huntington’s disease. The company’s leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies, including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, and Cubist. In addition, Alnylam and Isis co-founded Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics; Regulus has formed partnerships with GlaxoSmithKline and Sanofi. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for application in biologics manufacturing, including recombinant proteins and monoclonal antibodies.
Gilead Sciences, Inc. recently announced it has submitted an NDA to the US FDA for marketing approval of the Quad, a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.
“We continue to dedicate our HIV research and development efforts to advancing single-tablet regimens that address important patient needs,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Based on data from our pivotal studies, we believe that the Quad has the potential to be an important new treatment option for people living with HIV, and we are pleased to have reached this significant milestone less than 6 weeks after the unblinding of the second pivotal Phase III study.”
The NDA is supported by 48-week data from two pivotal Phase III studies in which the Quad met its primary objective of non-inferiority as compared to Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir (Study 103). Complete data from the Quad pivotal studies will be presented at a scientific conference in 2012. The NDA is also supported by Chemistry, Manufacturing, and Controls (CMC) information on the individual components of the Quad and the co-formulated single-tablet regimen.
The first single-tablet regimen for HIV, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the
The Quad contains four
Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in
Repligen Buys Novozymes Biopharma Unit
Repligen Corporation recently announced the execution of a definitive agreement to acquire the business of Novozymes Biopharma Sweden AB in a cash transaction of $22.7 million and future potential milestone payments of $5.6 million. This transformative acquisition will elevate Repligen to a world-leading supplier of products for manufacturing biologic drugs with the potential to yield sustainable growth and profitability in fiscal year 2013, beginning April 1, 2012. The combined company is expected to generate total revenues of approximately $50 million in fiscal year 2013.
The Novozymes Biopharma acquisition diversifies and expands Repligen’s product offering and customer base while doubling the company’s manufacturing capacity. Novozymes Biopharma AB is a leader in the manufacture and supply of growth factors used in mammalian cell culture and Protein A affinity ligands used in the production of monoclonal antibodies. The company is located in
“This acquisition positions Repligen as a leading producer of high-value, consumable products that will directly benefit from the long-term growth of the biologics market,” said Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “Earlier this year, we announced our strategic objective to transition into a commercially focused company, and the acquisition of the Novozymes business will deliver on that goal by significantly augmenting our product portfolio and providing a path to sustainable profitability.”
Repligen is currently a leader in the supply of four different forms of recombinant Protein A, a key ingredient used in the production of most monoclonal antibodies. Through this transaction, Repligen will acquire Novozymes “native” Protein A product, which is used in the production of several of the early blockbuster monoclonal antibody drugs. The combined company will be well positioned to fully benefit from the long-term growth of the monoclonal antibody market. There are more than 50 approved monoclonal antibody products and 200 candidates currently in clinical development, most of which are manufactured using Protein A. Importantly, as part of the acquisition, GE Healthcare and Repligen have extended the term of their existing supply agreement for recombinant Protein A from 2014 to 2021. A further key benefit of the acquisition is Repligen’s expansion into the cell culture ingredients market, which increases the company’s product breadth and opens a market opportunity for them in the production of fermentation ingredients and a future market opportunity as stem and cell-based therapies emerge.
The combined company will manufacture and sell more than 20 products to the biopharmaceutical industry, which are incorporated into the manufacture of more than 50 approved products and 200 products in clinical development. The products will be sold under long-term supply agreements with four leading life sciences companies as well as directly to a variety of end-users and will expand the customer base. The key products that Novozymes produces include insulin like growth factor (LONGR3 IGF-I), native and recombinant Protein A products, and other growth factors, which have potential applications in cell-based therapies.
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