Quality/GMPs

Articles

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

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

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19. 

FDA’s “Gold Standard” Critical for Biopharma R&D

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Proposing a New Method of Detecting Pinholes in Single-Use 

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Technology Innovations Improve Process Chromatography Performance

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

FDA Publishes Guidance on Drug-Drug Interaction Studies for a Therapeutic Protein

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

Drug Safety Summit Discusses Impact of COVID-19 on Pharma Supply Chain 

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Quality Control/Quality Assurance