Drug Development

Christa Myers is a process chemical engineer for CRB.

Articles

A new focus on speed to market creates challenges for facility design and construction.

The Need for Speed: How Operation Warp Speed Shifted the Pharma Industry

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Dr. Sabine Imamoglu is Product Supply, Pharmaceuticals, Pharmaceutical Affairs, Bayer AG.

Continued process verification for a cleaning validation program begins once the validation study is complete. 

Continued Process Verification for Cleaning Validation– Challenges and Pitfalls

Genezen has opened its new process development and analytical lab for viral vector production.

Genezen Starts Up Operations at Lenti- and Retroviral Vector Process Development Lab

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

From PharmTech: Detecting and Determining Quantitation Limits for Impurities

Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.

Denali Therapeutics and Takeda to Jointly Develop and Commercialize Investigational Treatment for FTD-GRN

Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.

Sterling Pharma Solutions Invests in Process Development and Manufacturing in Dudley, UK

John A. Thomas is the president of M-Star Simulations.

Advances in simulation and the development of digital twins.

Computational Fluid Dynamics in Upstream Biopharma Manufacturing Processes

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

Detecting and Determining Quantitation Limits for Impurities

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.



Partnership Aims to Accelerate and Improve Smart Bioprocess Development Solutions

 is an AFI member and participates in the AFI process validation working group.

Alessandro Regola is the AFI vice president in Milan and coordinator of the AFI Quality Section, and serves as pharmaceutical consultant in quality systems.

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

Process and Scaling