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2013 CMO Leadership Awards Winner Profiles DRUG TYPE: Biopharmaceuticals Fujifilm Diosynth Biotechnologies Morrisville, NC Manufacturing locations: Billingham, Teesside, U.K.; and Research Triangle Park, NC, U.S.A. www.fujifilmdiosynth.com (919) 337-4400 Contact: Dave Lescinski dave.lescinski@fujifilmdb.com DRUG LIFE CYCLE STAGES: Research & Development — preclinical, clinical (phase 1, phase 2, and phase 3); Drug Substance Production — primary process development and drug substance production SERVICES OFFERED: Nonsterile, proteins, and vaccines. "We are honored to be recognized for the 2013 CMO Leadership Awards in the categories of regulatory & productivity. Quality sets the foundation of everything we do to ensure patient safety and this is exemplified by our successful inspection history at our U.S.A. and U.K. sites. As a global leader in the contract development and manufacture of biopharmaceuticals, we look forward to building on this reputation." — Stephen A. Spearman, Ph.D., MBA, president Gallus BioPharmaceuticals St. Louis, MO Manufacturing locations: St. Louis, MO www.gallusbiopharma.com (314) 426-5000 DRUG TYPE: Biopharmaceuticals Contact: Claire Ruzicka claire.ruzicka@gallusbiopharma.com DRUG LIFE CYCLE STAGES: Research & Development — discovery, preclinical, clinical (phase 1, phase 2, and phase 3); Drug Substance Production -— primary process development and drug substance production SERVICES OFFERED: Generics, peptides, proteins, and sterile. "Gallus is delighted to be recognized for its regulatory leadership. Gallus is a uniquely flexible CMO with over a decade of commercial production based on an outstanding regulatory track record, with approval to supply product globally. The last FDA inspection resulted in zero Form 483 observations. Gallus continues to build on this performance through the dedication and commitment of our employees and ongoing investment in single-use and flexible stainless-steel bioreactors and advanced downstream technologies." — Mark Bamforth, president and CEO DRUG TYPE: Pharmaceuticals and Biopharmaceuticals GlaxoSmithKline Contract Manufacturing Brentford, Middlesex, UK Manufacturing locations: Australia, China, Europe, Japan, Middle East, North America, and South America www.gsk.com Contact: Russell Harris russell.b.harris@gsk.com DRUG LIFE CYCLE STAGES: Research & Development — clinical (phase 2 and phase 3); Drug Substance Production — primary process development and drug substance production; Formulated Drug Production — dosage form development, dosage form production, packaging, and logistics SERVICES OFFERED: Aseptic fill/finish, capsules, controlled substances, creams & ointments, cytotoxic & high-potency compounds, foams, gels, generics, injectables, liquids, lyophilized products, nonsterile, ophthalmics, OTC, parenterals (large volume), parenterals (small volume), peptides, powders (sterile), proteins, semisolids, solid dose, solutions & suspensions, sterile, sustained release, syringes (prefilled), and topicals. "GSK is continually striving to fulfill the contract manufacturing needs of our customers in today's challenging environment. We are proud to be seen as a leading company in the areas of quality, reliability, innovation, productivity, and regulatory. We do everything we can to offer a sustainable, robust value proposition that is at the leading edge within the contract manufacturing field. We are looking forward to another successful year." — Russell Harris, director, business development and third-party sales The CMO Leadership Awards 2013 39