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Crucell and NIH Sign Ebola Vaccine Manufacturing Contract
The National Institutes of Health (NIH, Bethesda, MD, www.nih.gov) has awarded a $27.6-million contract to the Dutch biotech company Crucell NV (Leiden, The Netherlands, www.crucell.com) for the manufacture of a recombinant Ebola vaccine for Phase I and early Phase II clinical trials.
Under the contract with the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases (NIAID), Crucell will manufacture up to ten batches of clinical material for an Ebola vaccine in its own manufacturing facility, using the company’s PER.C6 technology.
PER.C6 is a recombinant production technology for manufacturing inactivated-whole-virus, live-attenuated, live-vector, and subunit vaccines. Using the PER.C6 cell lines, which are derived from a human retinal cell, viruses can be cultured under serum-free conditions in formats ranging from roller bottles to bioreactors. Crucell currently is expanding its GMP-production capacity to 100-L working volumes.
The NIH production contract follows a deal last month in which NIH granted Crucell an exclusive patent license to commercialize Ebola vaccines. In addition to the NIH, Crucell has partnered with Aventis Pasteur, GlaxoSmithKline (GSK), the Walter Reed Army Institute of Research, and New York University to develop vaccines for influenza and malaria. The company also has licensed its cell line technology to pharmaceutical companies such as DSM Biologics, GSK, Johnson & Johnson’s Centocor, and Merck.