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.

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.

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.

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.