BioPharm International, November 2004 - BioPharm International

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BioPharm International, November 2004
Immunogenicity
A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 1: Considering Consequences of the Immune Response to a Protein
By Alexandra Worobec, M.D. , Amy S. Rosenberg, MD
Neutralization of therapeutic protein products does not produce an obvious clinical deficiency syndrome for all therapeutic protein products with endogenous counterparts, because many endogenous proteins are biologically redundant.
Industry Innovations
Let There Be Light: Plant-Made Pharmaceuticals' New Home is Underground
By Larry Holbrook, Ph.D. , Brent Zettl
The mine space is greater than the volume of all homes for a city of one million people. The second facility has been mapped at 22,500 acres.
Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFP
By Todd Ireland , Marty Siwak , Glen Bolton , Herb Lutz
Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
Validation
Validating Analytical Methods for Biopharmaceuticals, Part 2: Formal Validation
By Stephan Krause, PhD
When replacing an existing method, it may be necessary to compensate for a significant difference between the current and new method by adjusting the specifications.
International BioMarket
Biotechnology in Germany
By Horst Domdey
A German biotechnology company based in Martinsried, GPC Biotech, raised 78.6 million in June through public and private placements in Germany, the US, and other countries. "Our recent financing was one of the most successful biotech offerings in terms of proceeds for the year to date, on either side of the Atlantic," said Dr. Bernd Seizinger, CEO of GPC. It is now one of the few German biotechnology companies listed on NASDAQ.
Columns and Departments
Editorial—Educating The Masses About Biopharma
By Carol L. Fisher
Idon't know about you, but I found Senator John Kerry's assertion that President Bush was to blame for the US flu vaccine shortage quite laughable, but only until it became clear Kerry intended to continue railing about it throughout his final campaign thrust. As political tactics would have it, of course there was no mention of the Comprehensive Child Immunization Act of 1993, back-door price controls, and the resultant US dependence on external vaccine suppliers.
StreetTalk: Hedging Your Bets
By Brian O'Connell
Over the last five years, alternative investments have been the fastest growing investment strategy in institutional investment markets.
Regulatory Beat: Biotech Firms Face New GMP Policies
By Jill Wechsler
Even if FDA does not require pharma companies to co-market a diagnostic test, insurers and health plans
Monoclonal Antibodies for Cancer
By Melissa Elder
Cancer treatment has grown into a multibillion-dollar business responsible for saving and improving the lives of countless patients each year. One of the approaches generating a flurry of interest is monoclonal antibodies.

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