Genetic Engineering & Biotechnology News

AUG 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | | AUGUST 2017 | 23 Sophia Ktori Sanofi is looking to bolster its recombi- nant-based influenza vaccine portfolio through the acquisition of Protein Sciences for $650 million upfront and potentially up to another $100 million in milestones. The transaction, which has been approved by the Protein Sciences board and the ma- jority of its shareholders, is expected to close during Q3 2017, subject to regula- tory clearance. Protein Sciences notes that its Flublok ® Quadrivalent influenza vaccine is the only recombinant protein-based flu vaccine ap- proved by the FDA. The vaccine, which is manufactured using a 100% egg-free cell culture system, was cleared by the U.S. regulator for use in adults, in October last year. "The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg-based vac- cine," said David Loew, executive vice president and head of Sanofi Pasteur, Sano- fi's vaccines division. Headquartered in Meridian, CT, Pro- tein Sciences is exploiting its insect cell- based baculovirus expression vector system (BEVS) protein expression technology to develop recombinant protein vaccines and to offer research antigen and recombinant protein vaccine and therapeutics develop- ment and manufacturing services. The BEVS platform is based on an engineered baculovirus and proprietary expresSF+ ® Spodoptera frugiperda insect cell line. The firm claims the highly scalable system pro- duces high levels of pure, correctly folded protein more quickly and cost-effectively than other production systems. Protein Sciences is developing a num- ber of recombinant protein vaccine candi- dates, including a pandemic influenza vac- cine Panblok ® and FluNhance™, a recom- binant neuraminidase that is in develop- ment for boosting the efficacy of influenza vaccines. A recombinant protein-based Zika virus vaccine is also in development. Positive data from preclinical tests with the Zika virus vaccine were reported in January. In March, Protein Sciences reported that it has been charged with developing two new pandemic vaccine candidates against influenza N7N9 strains, under an existing, potentially $610 million Biomedi- cal Advanced Research and Development Authority (BARDA) pandemic influenza contract, awarded in September. The WHO and the FDA are separate- ly encouraging the use of non-egg-based influenza vaccine manufacturing meth- ods, including cell-based approaches. Last month, Seqirus, which claims to be the second largest global influenza vac- cine manufacturer behind Sanofi Pasteur, reported successfully scaling up its cell- based system for manufacturing influenza vaccines, to enable commercial produc- tion at its Holly Springs, NC facility. Headquartered in Lyon, France, Sanofi Pasteur is the world's largest vaccine-ded- icated company, with a vaccine portfolio spanning bacterial and viral diseases. The firm distributes more than 1 billion doses of its vaccine every year, including 200 mil- lion doses of seasonal influenza vaccine in 2016. Sanofi Pasteur reported revenues of approximately $5.2 billion in 2016. n Bioprocessing Speed to Clinic Robust Production Quality by Design Increased Titers Mitigate raw material virus contamination risks with our new virus media filter. Eliminate cell growth concerns with Flexsafe ® bags. Rely on proven stirred-tank design enhanced with single-use biomass measurement. Benefit from robust single-use clarification for up to 2000 L high performance fed-batch processes. Connect Upstream for Robust Production Sanofi to Buy Protein Sciences for Up to $750M Sanofi Adds an Egg-Free Influenza Vaccine to Its Portfolio

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