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February 27, 2013
Kevin Ott, executive director of the Bio-Process Systems Alliance, discusses the latest trends and issues surrounding single-use technologies and the role of his association.
February 20, 2013
Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.
February 02, 2013
The share of biologic-based drugs in the global pharmaceutical market is on the rise.
January 02, 2013
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
November 26, 2012
Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.
November 02, 2012
Policymakers must balance fundamental issues involving access to medicines and pricing.
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
October 02, 2012
The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.
September 01, 2012
There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.
August 02, 2012
A look at elastomer changeout times shows how industry knowledge improves operations and cost.