Articles by Haydia Haniff - BioPharm International

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Articles by Haydia Haniff

FDA Warns of Genzyme Product Contamination

Nov 13, 2009

The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

DASGIP Adds to iPhone Offerings for Scientists

Oct 15, 2009

In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online.

New USP Standards for Heparin Includes New Identity and Potency Tests

Oct 7, 2009

New heparin standards recently adopted by the United States Pharmacopeia (USP) include new tests to ensure the quality of the drug.

Vaccine "Manufactured" in Tobacco Plants

Aug 20, 2009

A new vaccine for norovirus has been produced in tobacco plants, a scientist reported on August 18 at the national meeting of the American Chemical Society in Washington DC.

Six Steps to Improve FDA Enforcement

Aug 12, 2009

FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.

Millipore Sues W.L. Gore & Associates for Patent Infringement

Aug 12, 2009

Millipore Corporation (Billerica, MA) has filed a lawsuit in the US District Court for the District of Massachusetts against W.L. Gore & Associates for infringement of Millipore's patent rights under US Patent No. 7,293,477, "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device."

FDA Approves Avastin for the Most Common Type of Kidney Cancer

Aug 4, 2009

The US FDA has approved Genentech's Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.

FDA Awards NIPTE $1.19 Million Contract to Help Develop QbD Guidance

Nov 14, 2008

The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications

Argos Develops Disposable Hood for Personalized Therapeutics Manufacture

Nov 14, 2008

A major problem in personalized medicine has been scale-up.

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