Process Development

Review by Exception: Connecting the Dots for Faster Batch Release

November 12, 2019

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.

Biopharma modeling, now and five years from now

November 11, 2019

Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.

Using TEM-Based Image Analysis to Validate the Presence of HA Spikes on Influenza VLPs

November 01, 2019

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

New Therapies Present Scaling Challenges

November 01, 2019

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The Principle of Scaling Down

November 01, 2019

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

GE Healthcare, CPI, and Cobra Biologics Introduce New AAV Purification System

October 24, 2019

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

New Virtual Reality Platform Offers Life Sciences Industry Training

September 27, 2019

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

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

September 19, 2019

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

Sanofi, Abbott Partner to Advance Diabetes Management

September 16, 2019

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

GE Healthcare to Partner with NIBRT for Biopharma Education Program

September 11, 2019

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.