Featured Articles
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Critical Issues In Outsourcing To A CMO
By Eric S. Langer, BioProcess International
Deciding to outsource biopharmaceutical manufacturing is a strategic decision with long-term consequences. Most companies deliberate carefully as they select a contract manufacturing organization (CMO). Because the factors involved in such deliberations vary widely among organizations — and they shift over time — my company has included an analysis of critical outsourcing issues as part of its fifth annual report and survey of biopharmaceutical manufacturing capacity and production.
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Shared Risk: A Regulatory Management Strategy
By John Avellanet, BioProcess International
Risk is inversely proportional to one's distance from a problem. For regulators, it seems straightforward to control biopharmaceutical and medical device risk. For pharmaceutical, biotechnology, and medical device executives, however, risk is hardly so clearly defined; it extends, grows, twists, and compounds through a chain of suppliers, consultants, and business partners.
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Featured Downloads
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Flyer: Contract Commercial Aseptic Manufacturing
PYRAMID's new, state-of-the-art, aseptic commercial manufacturing facility provides fill/finish services for both vial and syringe applications for the biopharmaceutical industries.
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Brochure: Pilot And Production Scale Freeze Dryers
Millrock production freeze dryers have achieved the recognition of being the highest performing machines in the industry. Typical shelf freezing and vapor collecting capacities are unmatched. Coupled with this is our easy-to-use intuitive control system, the Opti-Dry. Our units are fully validatable and built to cGMP guidelines.
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Datasheet: API Production Under GMP
All aspects of biotechnological production of active pharmaceutical ingredients (APIs) derived from mammalian cells are available at Rentschler Biotechnologie, from basic services for development and production, to process development in cooperation with clients, and validated routine GMP production.
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Case Study: Building Safety Into Isolator Controls Systems
As isolators become more customized to meet the requirements of specific pharmaceutical processes, the controls systems have been challenged to provide more safety and flexibility.
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