Manufacturing, Cell Therapies

Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

The authors present a review of the techniques commonly used for glycosylation analysis.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Isolators offer a safety and economic advantage for next-generation regenerative medicine products.

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a

apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).

WuXi's new US facility will manufacture CAR T-cell therapies and other cancer immunotherapies.

Sessions address cell therapies, serialization, contract services, and more.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Juno's new manufacturing facility in Washington state will support clinical trials for immunotherapies.

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

PharmaCell has finalized its purchase of the cell therapy production facility from TiGenix.

TxCell has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM).

The author describes automated equipment that uses functionally closed disposables.