BIO NEWS & VIEWS
Catalent Opens Bio-CoE DSM to open bio-site in Brisbane Catalent Opens Madison Bio-CoE Catalent Pharma Solutions has opened its new biomanufacturing Center of Excellence in Madison, WI. The new facility quadruples current biologics manufacturing capacity and allows the company to extend its offerings as well as enhance the efficiency and output of its GPEx cell line engineering technology and other mammalian cell lines. Catalent has moved its 89 employees to the 100,000-sq.-ft. Madison site, and eventually plans to employ more than 100 people at the site. Also, Catalent recently acquired an exclusive license to market Redwood Bioscience’s SMARTag precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). Catalent will combine its GPEx cell line expression system with SMARTag for the rapid development of stable, high-yielding cell lines, and a broad range of analytical and fill-finish services. The facility is designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, and features single-use technologies and unidirectional flow. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development labs, and separate microbiology and Quality Control functions. “Our new biomanufacturing Center of Excellence has been specifically designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing, and we will be pleased to welcome many of them on site at the official opening,” said Barry Littlejohns, president of Catalent’s Biologics business. “The extensive application of single-use technology greatly reduces the risk of cross contamination and gives us huge flexibility and scale, while our on-site capabilities enable us to provide our customers with solutions for even the most difficult to express proteins.”
DSM To Open Brisbane Bio-Mfg. Ops DSM Pharmaceutical Products will open its cGMP custom biopharmaceutical manufacturing facility in Brisbane, Australia in June 2013. The facility was built in cooperation with the Queensland and Commonwealth Governments of Australia. The site will provide cGMP mammalian cell-culture contract manufacturing services from process development through to commercial manufacturing. DSM Biologics operates with all standard technologies and has a portfolio of proprietary technologies for the optimization of bio-manufacturing. The facility has an annual output capability of 500kg and has expansion space available for further capacity utilization. Karen King, president of DSM Biologics, the biopharmaceutical manufacturing business of DSM Pharmaceutical Products, said, “We are thrilled to announce the June opening our of new
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cGMP facility in Brisbane. This operation combines DSM’s 25 years of experience and high-quality track record in mammalian cell culture manufacturing with a state-of-the-art commercial and development facility. Our partnership with the Government of Queensland and the Commonwealth of Australia has led to this important addition to the Australian biotechnology industry and will be a key contributor to the entire Asia-Pacific region.”
Fujifilm Diosynth Commissions Cell Banking Facility Fujifilm Diosynth Biotechnologies has commissioned its new mammalian cGMP Cell Banking Facility (CBF) at its Billingham, UK site. The new CBF is available to customers either as part of a larger development and manufacturing program, or as a stand-alone service. The CBF will support manufacturing programs for both the Billingham UK, and Research Triangle Park, NC facilities. The next stage of the company’s expansion is a cGMP manufacturing facility in Billingham, which is scheduled to open in early 4Q13. The facility will primarily utilize single-use technologies and will initially offer 200L and 1000L single-use bioreactors, with 2000L bioreactors planned for 2014. Steve Bagshaw, managing director, Fujifilm Diosynth Biotechnologies UK, said “I am delighted that we have commissioned the Cell Bank Facility within a year of its commencement, and have already started work on our first customer program. This is the next step in our strategy to grow our services in the CDMO field, becoming a world-class player across both microbial and mammalian cell culture platforms, offering a full life cycle support for our customers.”
Goodwin, Coldstream in ADC Alliance Goodwin Biotechnology, Inc. (GBI) and Coldstream Laboratories have entered a collaboration to develop and manufacture high-potency, highly cytotoxic materials, such as small molecules, protein toxins, cytotoxic antibody drug conjugates (ADCs), and other bioconjugates. GBI will collaborate with Coldstream to perform a number of activities using Coldstream’s cGMP platform of services, including analytical testing, formulation, liquid or lyophilized fill and finish, storage and shipment of manufactured highly-potent bioconjugates. Muctarr Sesay, Ph.D., vice president of process development at GBI, remarked, “To address growing market demands for ADCs employing highly potent and cytotoxic therapeutic payloads, it has recently become clear that a collaboration is needed with a company like Coldstream that has high-containment and isolation capabilities relative to the handling, processing, characterization, fill and finish, lyophilization, and storage of these cytotoxic materials.” I
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