BioPharm International-07-01-2003

Biopharmaceutical manufacturers face many bioprocessing concerns including safety, flexibility, maintenance, capacity, capital investment, and process costs. Disposable products can reduce some of the burden.

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.

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.

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.

Good Outsourcing Practices

July 01, 2003

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.

FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents

Columns and Departments

July 01, 2003

A Dutch biotech company?s $100 million investment puts the spotlight on biomanufacturing capacity