Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

Where Winning is the Only Thing

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.
Nov 1, 2009

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.

Celltrion and Hospira to Comarket Celltrion's Biosimilars

Oct 12, 2009

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

Diminutive Bacteria Useful for 0.2-μm Filter Studies, FDA's Brorson Says

Oct 7, 2009

Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies.

Pharma and Healthcare Reform, Part 2

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.
Oct 1, 2009

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

FDA Approves H1N1 Flu Vaccines Produced in Eggs

Sep 16, 2009

The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.

Lonza Building Cell Therapy Facility in Singapore

Sep 11, 2009

Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.

Novavax Achieves Good Results for Vaccines Against Seasonal Flu and H1N1

Sep 2, 2009

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

A True Assessment of Risk

If risk assessments only identify "the usual suspects," the process will not add much value.
Sep 1, 2009

If risk assessments only identify "the usual suspects," the process will not add much value.

Quality Risk Management Demystified at CMC Strategy Forum

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.
Sep 1, 2009

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.

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