Drug Development

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Articles

Flexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.

Determining Minimum Batch Size

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.

Mohammad Ovais is senior pharmaceutical scientist at Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.

Andrew Walsh, M.S., certified Lean Six Sigma Black Belt, is President of the Center for Pharmaceutical Cleaning Innovation in Hillsborough, NJ. He can be reached at andy.walsh@centerforpharmaceuticalcleaninginnovation.org.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Cleaning Limits—Why the 10-ppm and 0.001-Dose  Criteria Should be Abandoned, Part II

Norm Fong, technical transfer manager for WellSpring, is responsible for overseeing technology transfer and validation activities.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties.
\

Effective Technology Transfer and Validation Strategies with CMOs

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

SmithKline Beecham Gets Warned for Contamination

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Researchers Present Novel Method for Scale-Up of Stem Cell Production

Walter Matzmorr, Dr. Ing., is Principal at Tunnell Consulting, Inc.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Planning a Biologics Facility Start Up

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

Modern Manufacturing Comes of Age

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

Integrating Single-Use Systems in Pharma Manufacturing

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Experts discuss the key considerations in the development of an autoinjector.

Process and Scaling