BioPharm International, April 2005 - BioPharm International

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BioPharm International, April 2005
Special Section
Developing the Future: Big Questions, Multiple Answers
By Derek Ellison, Ph.D.
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.
Articles
Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors
By Roby P. Blasini
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.
Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration
By Anurag S. Rathore, PhD , Raj Krishnan , Stephanie Tozer , Dave Smiley , Steve Rausch , James E. Seely, Ph.D.
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.
RFID in the BioPharmaceutical Supply Chain
By Mikael Ahlund, Ph.D.
Mass serialization, or the ability to store a unique serial number for each item, is the most useful feature of RFID tags.
A Case Study of Developing Analytical Methods
By Wendy Saffell-Clemmer , Eddie Massey , David Gooding , Reuben Lidster , Nathan Pease , Elizabeth Oslos
Contract manufacturers must plan for increased analytical resources in development and quality control.
Outsourcing A Survival Strategy or a Tool for Speed to Market A Case Study
By Michele Antonelli, Ph.D.
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.
Columns and Departments
From the Editor in Chief—Polishing and Protecting Biopharm's Public Image
By Carol L. Fisher
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.
StreetTalk: Hello, It's Me: VCs Once Again Wooing Biopharm Companies
By Brian O'Connell
With biotech valuations at the lowest point in years, the resulting investment opportunities are multiplying — seemingly by the hour.
The Top Five Drivers of a Successful Out-licensing Process
By Ranan Lachman , Marc Samet, Ph.D.
Out-licensing has become a crucial part of most biotech companies' business strategies.
Final Word: Insurance for Biotech Companies
By Ira M. Gottlieb, Esq , Louis Chiafullo, Esq
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.
Regulatory Beat: FDA Eyes Spectrum of Policies for Follow-On Proteins
By Jill Wechsler
Even if some clinical testing is needed, generics makers argue that no one-size-fits-all testing approach is appropriate for the broad range of biopharmaceutical complexities.

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