Articles by Laura Bush - BioPharm International

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Articles by Laura Bush

Gaucher Patients Can Be Treated with Protalix's Drug During Cerezyme Shortage

Aug 20, 2009

Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease.

SAFC Develops First Chemically Defined Hydrolysate Replacement

Aug 12, 2009

SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials.

Quality Risk Management Demystified at CMC Strategy Forum

Aug 12, 2009

The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use?

Sartorius Stedim and SAFC Collaborate to Combine Upstream and Downstream Expertise

Aug 6, 2009

Sartorius Stedim Biotech (Goettingen, Germany) and SAFC Biosciences (St. Louis, MO), a division of SAFC, have entered into a partnership to share expertise, support each other in developing custom solutions for customers, and generate data on the performance of equipment in different applications.

Laying the Foundation

Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.
Aug 1, 2009

Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.

Facing Down the Enemy

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.
Jul 1, 2009

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.

Genzyme Detects Virus Contamination of Bioreactor, Halts Production

Jun 17, 2009

Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there.

The Ups and Downs of the FDA Budget

Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.
Jun 1, 2009

Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.

New Coalition Aims to Improve Pharmaceutical Supply Chain

May 13, 2009

Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety.

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