BioPharm International
July 01, 2003
Columns and Departments
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Biopharmaceutical manufacturers face many bioprocessing concerns including safety, flexibility, maintenance, capacity, capital investment, and process costs. Disposable products can reduce some of the burden.
July 01, 2003
Good Outsourcing Practices
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Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.
July 01, 2003
Product Development Issues
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In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
July 01, 2003
Product Development Issues
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7
A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.
July 01, 2003
Good Outsourcing Practices
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7
Working with a contractor reduces time-to-market, risk, and debt, while providing expertise, equipment, and flexibility - but those benefits accrue only if you plan and communicate with your outsourcing partner.
July 01, 2003
Columns and Departments
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7
FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents
July 01, 2003
Columns and Departments
16
7
A Dutch biotech company?s $100 million investment puts the spotlight on biomanufacturing capacity