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November 01, 2014
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
July 01, 2014
Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
November 01, 2013
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
August 01, 2013
The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.
March 01, 2013
Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
September 01, 2012
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
August 01, 2012
The authors review the various analytical methods that can enable use of PAT.
March 02, 2012
Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.
June 01, 2011
The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
March 01, 2011
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.