BioPharm International, August 2006 - BioPharm International

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BioPharm International, August 2006
Feature Article
Production of Recombinant Therapeutic Proteins in the Milk of Transgenic Animals
By Yann Echelard , Carol A. Ziomek , Harry M. Meade
Capital investments in production plants represent a significant portion of the cost of new recombinant drugs
Articles
Successful Bioreactor Installation: What it Takes
By Byron Spurr
Understand your company's requirements, define responsibilities,and manage your team effectively.
Biopharmaceuticals: Approval Trends in 2005
By Gary Walsh, PhD
In 2005, 10 biopharma- ceuticals gained marketing approval in the US or Europe, although only five of them were genuinely new molecular entities.
Applying Process Analytical Technology to Biotech Unit Operations
By Anurag S. Rathore, PhD , Ashutosh Sharma , David Chilin
Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.
Columns and Departments
From the Editor in Chief: Science, Control, and the Seemingly Uncontrollable
By Laura Bush
Is it possible to reconcile phage therapy, which is inherently variable, with requirements for tight product characterization and control?
Legal Forum: Putting the "Co" in Development and Promotion: The New Biotech-Pharma Collaborations
By Sergio Garcia
Wyeth today relies on biotech product revenue to drive approximately 25% of its revenues.
StreetTalk: Transition at the Fed: From Greenspan to Bernanke
By Brian O'Connell
When former Federal Reserve chairman Alan Greenspan's term in office expired on January 31, 2006, many people said, "There goes a legend." Maybe the better expression was, "Here comes the spin."
Final Word: Omnitrope's Approval: What Does It Mean For Other Generics?
By Nathan A. Beaver , Kelly A. Hoffman
Congress is not considering legislation that would expand FDA authority to regulate biologics.
Regulatory Beat: Biologics Oversight Challenges Federal Regulators
By Jill Wechsler
FDA did not gain any real teeth for regulating unsafe and ineffective products until a national health disaster in 1937 roused a public outcry.

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