The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/85321
Cedarburg Hauser Pharmaceuticals Grafton, WI www.cedarburghauser.com (262) 376-1467 DRUG TYPE: Pharmaceuticals DRUG LIFE CYCLE STAGES: Drug Substance Production – primary process development and drug substance production Manufacturing locations: Denver, CO and Grafton, WI Contact: Mark Millar info@cedarburghauser.com DRUG TYPE: Biopharmaceuticals CMC Biologics Bothell, WA www.cmcbiologics.com (425) 415-5438 Manufacturing locations: California, U.S.A., Washington, U.S.A., and Copenhagen, Denmark Contact: Stacie D. Byars sbyars@cmcbio.com DRUG LIFE CYCLE STAGES: Research & Development – pre-clinical and clinical (phase 1, phase 2, and phase 3) Drug Substance Production – primary process development and drug substance production SERVICES OFFERED: Active pharmaceutical ingredients , controlled substances, cytotoxic & potent compounds, drug conjugates, generics, lyophilized products, and non-sterile. SERVICES OFFERED: Injectables, liquids, parenterals (large volume), parenterals (small volume), and proteins. "Satisfaction with a CMO is a function of the strength of its project management. Effective communication by project management not only improves productivity, but also ensures on-time delivery." — Tony Laughrey, CEO "CMC Biologics continually innovates to advance biopharmaceutical manufacturing to the next level. Our expertise in cGMP process development and manufacturing puts our clients' projects in an optimal position to succeed. The recent MHRA approval demonstrates our continued commitment toward compliance and high-quality systems, which is the foundation of our customers' clinical and commercial success. CMC Biologics is the industry leader among CMO's in reliability, technical excellence, and quality. Right. On Time." — Claes Glassell, chief executive officer Coldstream Laboratories, Inc. Lexington, KY www.coldstreamlabs.com (859) 977-8600 DRUG TYPE: Pharmaceuticals and Biopharmaceuticals Manufacturing location: Lexington, KY Contact: Eric Smart, executive vice president esmart@coldstreamlabs.com DRUG LIFE CYCLE STAGES: Research & Development – pre-clinical and clinical (phase 1, phase 2, and phase 3) Formulated Drug Production – dosage form development and dosage form production SERVICES OFFERED: Aseptic fill/finish, cytotoxic & high-potency compounds, generics, injectables, liquids, lyophilized products, parenterals (small volume), proteins, solutions & suspensions, and sterile. "Coldstream develops and manufactures parenteral products in liquid and lyophilized dosage forms. We have built a foundation around creating a winning team environment based on solid strategy. When the workforce is fully engaged in producing a high quality product, you develop effective efficiency models based on both scientific knowledge and the engineering capabilities of the process and equipment. We are constantly improving, with the addition of state-of-the-art equipment and the expansion of physical production areas and laboratory space." — Larry Kranking, president & CEO DRUG TYPE: Pharmaceuticals and Biopharmaceuticals DRUG LIFE CYCLE STAGES: Research & Development – clinical (phase 1, phase 2, and phase 3) Drug Substance Production – primary process development and drug substance production Formulated Drug Production – dosage form development, dosage form production, and packaging SERVICES OFFERED: Aseptic fill/finish, generics, injectables, liquids, lyophilized products, parenterals (large volume), parenterals (small volume), proteins, solutions & suspensions, sterile, syringes (pre-filled), and vaccines. "There are many reasons why biopharmaceutical companies count on us to produce a consistently dependable product. First, we have a manufacturing facility with the right capabilities, equipment, and location, and a team of collaborative, experienced subject-matter experts. We have also put in place a flexible infrastructure with processes that allow for client customization and have strived as an organization to learn from our mistakes, becoming better listeners throughout the process." — Cory Lewis, vice president of business development & marketing The CMO Leadership Awards 2012 37 Cook Pharmica Bloomingtom, IN www.cookpharmica.com (812) 355-6746 Manufacturing location: Bloomington, IN Contact: Brian Lange bus.dev@cookpharmica.com DRUG LIFE CYCLE STAGES