Drug Development

Articles

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

APC and Bavarian Nordic Build 500-L Single-Use Biologics Pilot Plant

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

GE Healthcare, Cobra Biologics, and CPI Team Up for AAV Vector Manufacturing

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

Lonza Expands Product Lifecycle Management Capabilities

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development. 

Swedish Government and GE Healthcare Open an Innovation Center for Life Sciences

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies

Claire Hill is solutions support manager at IDBS.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. 

Continued Process Verification and the Drive to Digitize the Process Validation Lifecycle

Naheed Sayeed-Desta is manager of process validation at Apotex, Inc.

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

Agnes Shanley is senior editor of Pharmaceutical Technology.

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.

Moving Toward Unified Process Control for Biopharma

MilliporeSigma targets emerging biotechs with US development center and global grants.

Process and Scaling