Life Science Leader Magazine Supplements

CMO 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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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 60 SERVICES & CAPABILITIES: process developm ent and scale-up; API for toxicology studies, clinical trials, and post-approval manufacturing; cGMP manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPIs); comprehensive analytical support including methods development and validation; regulatory compliance & quality assurance support: filing support for Investigational New Drug; applications (INDs), New Drug Applications (NDAs) and Drug Master Files (DMF). "Recognition in all five categories by Life Science Leader and Nice Insight is a testament to the Ash Stevens team. It is their steadfast commitment to our customers' unique drug programs that makes being ranked in the top 10% of CMO's worldwide an absolute honor for us all. Acknowledgement by large pharma and emerging biotech alike is an affirmation of our level of engagement with customers and our top quality science." SERVICES & CAPABILITIES: aseptic fill/finish, injectables, liquids, parenterals (small volume), proteins, vaccines, cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization, clinical and commercial product manufacturing, purification, bulk packaging, final product filling, stability testing and regulatory strategy, submission, support "At Avid, our goal is to be a strategic partner for our clients through every stage of product development. We do this by helping our clients meet tight timelines and providing consistent high quality GMP manufacturing services using our knowledge and expertise, that allows them to advance seamlessly from early clinical development through commercialization. We are dedicated to our clients' success and take great pride helping bring important biologics to the patients who need them." SERVICES & CAPABILITIES: ADCs (antibody drug conjugates), aseptic fill/finish, cartridges, cytotoxic & high potency compounds, emulsions, generics, injectables, liquids, liposomes, lyophilized products, nano-suspension, parenterals (large volume ) parenterals (small volume), powders (sterile), proteins, solutions & suspensions, sterile, sterile crystalization and ampoules, syringes (prefilled) , vaccines "In 2013, Baxter's BioPharma Solutions business announced a third expansion of their contract manufacturing facility in Halle, Germany to meet clients' growing needs for cytotoxic manufacturing. Cancer incidence is on the rise and cytotoxic therapies continue to be at the center of oncology treatment programs. Through this expansion and our advanced technologies, we will continue to support pharmaceutical companies' efforts to address patient needs worldwide. We believe in our customers and the patients they serve." DRUG TYPE: Pharmaceuticals, Biopharmaceuticals DRUG TYPE: 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: Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Primary Process Development, Drug Substance Production DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) Formulated Drug Production: Dosage Form Development, Dosage Form Production, Packaging DRUG TYPE: Pharmaceuticals, Biopharmaceuticals STEPHEN MUNK CEO STEVEN KING president & CEO Burkhard Wichert vice president, manufacturing CATEGORIES WON CATEGORIES WON CATEGORIES WON Baxter BioPharma Solutions Deerfield, IL +1 800 422 9837 or + 1 224 948 1812 Donna Abear Key locations: Bloomington, IN , and Round Lake, IL, U.S.A.; Halle (Westfalen), Germany Avid Bioservices Tustin, CA +1 714 508 6100 Jon Gingrich Key locations: Tustin, CA Ash Stevens Riverview, MI +1 734 282 3370 James Hamby Key locations: Detroit and Riverview, MI

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