Biologic Drugs

Feb 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Debottlenecking downstream mAb purification.
Feb 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A nickel's worth of free advice to the competition could come at the expense of your bottom line.
Jan 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Technology may expedite operations, but the absence of the human element could cost dearly.
Jan 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Challenges remain, particularly for early-stage biopharmaceutical companies.
Dec 08, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology
On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.
Dec 02, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharma companies must balance demand for new drugs while facing reduced R&D spending.
Nov 10, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
Nov 02, 2011
Pharmaceutical Technology
Biosimilar manufacturers need better expression systems and analytical tools to compete.
Nov 02, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Small drug companies with hopes of achieving $1 billion in sales can pursue various strategies.
Oct 06, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.
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