Manufacturing

Articles

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.

Oxgene Launches TESSA Technology for AAV Manufacture at Scale

Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture. 

Fujifilm Irvine Scientific Becomes Worldwide Distributor of Cellnest

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.

Cytiva Invests $500 Million Over 5 years to Expand Global Capacity

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy. 

Cobra and CombiGene Sign Agreement for Plasmid Production for Gene Therapy

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

Catalent Invests $130 Million to Expand Gene Therapy Manufacturing Capacity

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01. 

Cobra Biologics Develops Master Cell Banks for CombiGene’s Gene Therapy

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

FDA Approves First Cell-Based Gene Therapy for MCL

Feliza Mirasol is the science editor for 

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Commercialization Poses Challenges for Cell and Gene Therapies

Sangamo will receive a $75 million upfront license fee payment and will be eligible to earn up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones. 

Novartis and Sangamo Announce Gene Therapy Collaboration for up to $795 Million

This method is expected to help bring gene therapies to market faster, safer, and cheaper.

Manufacturing, Gene Therapies