Manufacturing

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

Ties between the biotechnology industry and university research are crucial.

Using a competency-based approach to effectively train biopharmaceutical industry staff.

The authors describe a validation master plan for closed-vial filling technology.

Manufacturers and regulators struggle to control phony versions of crucial medicines.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

A one-day sign off for batch records is considered a best practice in the industry.

The authors review the various analytical methods that can enable use of PAT.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011.

Industry wants more innovation, but can suppliers meet customers' needs?

The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

The contract provider needs to know as much as the NDA holder.

Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.

A review of key industry shifts and promises for the future.

Charles H. Squires of Pfenex discusses advances in expression platform solutions.

Industry experts discuss significant achievements. Plus: What's in store for the future.

Ray O'Connor, an operations consultant with NIBRT, addresses aseptic processing, including how to avoid contamination, and cleanroom best practices. Posted May 2012.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has formally adopted a memorandum of understanding (MoU) with key partners for a harmonised, European system for medicines verification.