Development

Articles

PSE, a supplier of advanced process modeling software and services, plans to become part of Siemens Digital Industries. 

Siemens Plans to Acquire PSE

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

BIA Separations Launches AAV Process Development Service to Accelerate Gene Therapy Production

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

Sanofi, Abbott Partner to Advance Diabetes Management

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

GE Healthcare to Partner with NIBRT for Biopharma Education Program

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

Predictive Digital Twins Control Bioprocesses for MAb Production

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Balancing CMC Priorities

Agnes Shanley is senior editor of BioPharm International.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Industrializing Cell and Gene Therapies

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Bringing Gene Therapies to Market

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

NIIMBL and FDA Partner in Biopharmaceutical Manufacturing

Mark Witcher is senior consultant at Brevitas Consulting, witchermf@aol.com

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures. 