Manufacturing, Gene Therapies

In this episode of Drug Digest, editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.

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

Burgeoning CGT modalities bring promise and challenges.

mRNA may be a modality whose chief advances are yet to come.

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 agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

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.

The current lack of standardization within the industry can be attributed to the recent rapid growth of the cell therapy market and the associated drive to improve the efficiency and cost-effectiveness of production.

The pin-point system is completely modular, allowing for different components to be selected for optimal performance specific to the gene targets.

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.

Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.

New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.

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.

There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.

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

A slew of late-stage clinical trials is expected to push new regenerative medicines onto the market in the next few years.

Improvement in viral vector yield has become integral to new cell and gene therapy product development.

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.

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

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

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

For cell and gene therapies to reach their full potential, changes in manufacturing must be explored.