BioPharm International-04-01-2005

BioPharm International

From the Editor in Chief—Polishing and Protecting Biopharm's Public Image

April 01, 2005

Columns and Departments

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You don't really care what people say about you (the biopharm industry) behind your back, do you? According to a recent survey of 670 BioPharm International subscribers, conducted by Derek Ellison from Eden BioDesign, some of you care very much about the public's perception of the industry.

Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors

April 01, 2005

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During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts.

Outsourcing A Survival Strategy or a Tool for Speed to Market A Case Study

April 01, 2005

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Outsourcing is becoming increasingly widespread and essential in the biopharmaceutical industry. Its imprint on biotech world business and on the development of biopharmaceutical drugs is becoming ever more pronounced. It is estimated that almost one-half of biopharmaceutical companies contract out at least part of the production of their products. On the other hand, those companies that do not outsource production often contract out some of their development activities.

Final Word: Insurance for Biotech Companies

April 01, 2005

Columns and Departments

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Biotechnology and life sciences companies come in all shapes and sizes. Some are multinational companies with vast resources and others are small companies working with a few new compounds. Regardless of size or market position, these companies should all have one common question of those that handle their insurance: Will their current insurance program protect their assets and investments in the event of a significant loss? Understanding the nature of risks, acquiring suitable insurance, and comprehending policy issues when claims arise are essential to protecting assets and obtaining reimbursement when losses occur.

Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration

April 01, 2005

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Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes - chromatography and filtration.

Developing the Future: Big Questions, Multiple Answers

April 01, 2005

Special Section

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When you don't know the answer to a question, ask an expert. If the question is really big, ask more experts. If you have a collection of difficult questions, run a poll of many experts. That, in effect, was the impetus for Eden Biodesign to survey 670 BioPharm International subscribers with questions as to what will be the development mechanism to achieve safe, effective, and cheap new medicines.