Regulatory

Jul 01, 2006
BioPharm International
A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape.
Jul 01, 2006
BioPharm International
Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.
Jun 27, 2006
BioPharm International
On August 12, 2003, Johnson & Johnson began recalling certain batches of its anemia drug, Eprex (epoetin alfa, sold as Procrit in the US), in most countries outside of the United States.
Jun 27, 2006
BioPharm International
Protein aggregation is a term that can include many types of aggregation, from rapidly reversible aggregation caused by non-covalent bonds to irreversible aggregation in the form of covalent oligomers.
Jun 27, 2006
BioPharm International
"Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston.
Jun 27, 2006
BioPharm International
By BioPharm International Editors
A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.
Jun 01, 2006
BioPharm International
Glavin is preparing a plan to modernize ORA through organizational changes . . .
Jun 01, 2006
BioPharm International
Air filtration also needs a filter integrity test method to guarantee the sterility of critical parameters.
Jun 01, 2006
BioPharm International
By BioPharm International Editors
Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.
May 01, 2006
BioPharm International
The Food and Drug Administration recently unveiled its long-awaited Critical Path Opportunities List, which maps out a number of "scientific projects" for improving the testing and production of biotech therapies. In its March report, FDA recognizes that problems in the characterization, testing, and quality management of medical products can delay clinical trials and even completely block drug development.
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