Drug Development

Articles

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

GE Healthcare to Equip Cell Therapy Manufacturing Facility with Single-Use Platform

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

TxCell Completes CAR-Treg Manufacturing Process Development

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Evaluating Surface Cleanliness Using a Risk-Based Approach

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.

A Revised Aseptic Risk Assessment and Mitigation Methodology

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

Eli Lilly Wins 2017 Facility of the Year Award

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

Agnes Shanley is senior editor of Pharmaceutical Technology.

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.

Reinventing Lean Six Sigma for the Pharmaceutical Industry

Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA
colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry. 

Six Sigma and the Path to Quality

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.  

Continuous Manufacturing Presses On

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Process and Scaling