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QUALITY RELIABILITY PRODUCTIVITY REGULATORY INNOVATION K E Y W W W.C M O L E A D E R S H I PA W A R D S .C O M 2015 CMO LEADERSHIP AWARDS WINNERS Company Profiles LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 63 DRUG TYPE: Biopharmaceuticals DRUG TYPE: Pharmaceuticals, Biopharmaceuticals DRUG TYPE: Pharmaceuticals, Biopharmaceuticals DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Primary Process Development, Drug Substance Production DRUG LIFE CYCLE STAGES: Research & Development: Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Formulated Drug Product: Dosage Form Development, Dosage Form Production DRUG LIFE CYCLE STAGES: Research & Development: Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Primary Process Development, Drug Substance Production Formulated Drug Production: Dosage Form Development, Dosage Form Production, Packaging "Cobra has been manufacturing plasmid therapeutics and DNA vaccines for more than 16 years. Our DNA platform process is based on Cobra's pioneering heritage in gene therapy manufacturing and technology development. Cobra's experienced and expert team have a strong track record for producing non-GMP, high quality, and GMP plasmid DNA for preclinical, clinical, and commercial supply, operating efficiently and consistently. Cobra's DNA programs have full regulatory support from a dedicated Quality Assurance (QA) team." "Coldstream Laboratories, a Piramal Enterprises business, focuses on quality and innovation to ensure exceptional service for our partners. Delivering creative solutions and skillful manufacturing using mobile isolator technology is central to our business. We are growing the Coldstream facility to include a second filling line to accommodate a wider range of products and larger batch sizes. Our integration with the existing Piramal sites leverages our strength for the formulation/fill/finish of ADCs and commercial sterile injectables." "Cook Pharmica is delighted to once again be recognized by the industry through the CMO Leadership Awards. Our continued focus on delivering quality products in a timely manner is integral to our service offering and very important to our customers and their patients. Our focus on being a flexible and reliable partner has proven to be a differentiator and has helped make us the CMO of choice for the biopharmaceutical clients that we serve." SERVICES & CAPABILITIES: aseptic fill/finish, injectables, lyophilized products, non-sterile, peptides, proteins, sterile, syringes (prefilled), vaccines SERVICES & CAPABILITIES: aseptic fill/finish, cytotoxic & high potency compounds, generics, injectables, liquids, lyophilized products, parenterals (small volume), peptides, solutions & suspensions, sterile SERVICES & CAPABILITIES: aseptic fill/finish, cartridges, cell culture manufacturing, generics, injectables, liquids, lyophilized products, parenterals (large volume), parenterals (small volume), peptides, proteins, solutions & suspensions, sterile, syringes (prefilled), vaccines PETER COLEMAN CEO ERIC SMART president & CEO Tedd Green president CATEGORIES WON CATEGORIES WON CATEGORIES WON Cook Pharmica, LLC. Bloomington, IN www.cookpharmica.com +1 877 312 2665 Cory Lewis cory.lewis@cookpharmica.com Key locations: Bloomington, IN Coldstream Laboratories, Inc. Lexington, KY www.coldstreamlabs.com +1 859 977 8600 Christopher Verbicky, Ph.D. customerservice@coldstreamlabs.com Key locations: Lexington, KY Cobra Biologics Keele, Staffordshire, United Kingdom www.cobrabio.com +44 1782 714181 Jason Rahal sales@cobrabio.com Key locations: Keele, UK; Matfors, Sweden; Sodertalje, Sweden