Articles by Erik Greb - Pharmaceutical Technology

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Articles by Erik Greb

Platform Technologies

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
Mar 2, 2012

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Robots' Role in Flexible Fill–Finish Lines

Robotics can play a role in fill–finish production.
Jan 18, 2012

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.

Cutting Prices to Save Sales

Copay coupons may help patients and drugmakers, but who ends up holding the bag?
Jan 2, 2012

Copay coupons may help patients and drugmakers, but who ends up holding the bag?

Baxter and Momenta to Develop Follow-On Biologics

Dec 29, 2011

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.

Ranbaxy Signs Consent Decree with FDA

Dec 29, 2011

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.

HHS and Novartis Dedicate First Cell-Based Flu Vaccine Plant in US

Dec 22, 2011

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.

Moving from a Reactive to a Systemic Approach to Manage Risk

Dec 21, 2011

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.

FDA Warns Novartis of Violations at Three Plants

Dec 15, 2011

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.

PhRMA Foundation Funds Comparative-Effectiveness Research

Dec 8, 2011

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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Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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