Manufacturing, Cell Therapies

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

The clinical-stage biopharmaceutical company has announced the opening of a new gene therapy manufacturing facility in Modiin, Israel, which is anticipated to be the production site of the company’s lead cancer drug candidate.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.