BioPharm International, July 2004

Risk Reduction

BSE Offers Lessons in Risk Assessment

By Paula J. Shadle, PhD

The approaches taken to containing the risk of BSE reveal patterns in the difficulties of performing and reacting appropriately to risk analysis.

Separation and Purification

Affinity Chromatography — from Textile Dyes to Synthetic Ligands by Design, Part I

By John Curling

Very significant progress has been made since the mid-1970s when dye ligands were first introduced.

Hormone Technology

Oral Delivery and Recombinant Production of Peptide Hormones, Part II: Recombinant Production of Therapeutic Peptides

By Nozer M. Mehta

This technology includes an efficient and scalable in vitro enzymatic amidation step for peptide hormones.

Biosafety

Biosafety Considerations for Cell-Based Therapies

By Darin J. Weber, Ph.D.

Is it safe? Answering that question for therapies based on living cells is not simple.

Columns and Departments

Regulatory Beat: Politics vs. Science in Biomedical R&D

By Jill Wechsler

The debate over drug importation is a prime example of politics trumping science as members of Congress reject the consensus of scientists and policy experts that opening US borders to therapies from abroad raises serious public health concerns.

StreetTalk: Hello, Mr. (Bio) Chips

By Brian O'Connell

According to a 2002 report by the consulting firm BioPerspectives, the protein biochip market will reach $700 million in sales by 2006.

Operations Excellence: BioPharma Consortium Meets in California and the Netherlands

By Amir London

Although there are many differences between the industries, especially related to regulatory requirements, there are enough similarities that the future of biopharmaceuticals with respect to contract manufacturing might look much like the semiconductor industry.

Career Development: Keeping Your Secrets in Your Company

By Donald A. Beshada

The employer's first step in considering whether to use non-competition and non-disclosure agreements is to assess, analyze, and understand the benefits of such agreements.

Final Word: Canada's Landmark Decision: Planting the Seed

By Jane E. Clark, BSU

Commercial embodiments of genetically modified inventions are protected in Canada.