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The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
Mar 2, 2012
By:
Erik Greb, Angie Drakulich
The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
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Robotics can play a role in fill–finish production.
Jan 18, 2012
By:
Erik Greb
The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.
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Copay coupons may help patients and drugmakers, but who ends up holding the bag?
Jan 2, 2012
By:
Erik Greb
Copay coupons may help patients and drugmakers, but who ends up holding the bag?
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Dec 29, 2011
By:
Erik Greb
On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.
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Dec 29, 2011
By:
Erik Greb
Last week, Baxter International and Momenta Pharmaceuticals entered into a global collaboration to develop and commercialize follow-on biologic products. The two companies expect to close the transaction during the first quarter of 2012, subject to customary closing conditions.
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Dec 22, 2011
By:
Erik Greb
Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.
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Dec 21, 2011
By:
Erik Greb
Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.
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Dec 15, 2011
By:
Erik Greb
In a Warning Letter, FDA cited "significant violations" of CGMP regulations, including several repeat observations, at three Novartis facilities located in Colorado, North Carolina, and Canada.
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Dec 8, 2011
By:
Erik Greb
Last week, the Pharmaceutical Research and Manufacturers of America Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program. The program is formally known as the PhRMA Foundation Center of Excellence for a Comparative-Effectiveness Research Educational Program. The funds are the foundation's first grants to educational institutions.
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