Manufacturing, Gene Therapies

The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.

The combined solutions are currently available on the market.

Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.

Emmes’ new facility is designed to support clients conducting cell and gene therapy research worldwide.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

Vibha Jawa, executive director at Bristol Myers Squibb, and Luke Schenck, principal scientist at Merck & Com, discuss cell & gene therapies and co-processed APIs respectively.

Significant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.

CBER maps modernization plan to handle surge in research and applications.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.

Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.

Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

Precompetitive consortiums seek solutions to industry-wide challenges.