Manufacturing

Articles

Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.

Paragon Bioservices Expands Gene Therapy Manufacturing Capacity

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

Pfizer and Sangamo Partner on Gene Therapy for Lou Gehrig's Disease

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

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood 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.

Orchard Therapeutics Opens Gene Therapy Laboratory Facility

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

Lonza in Gene Therapy Licensing Agreements

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.

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy

The Cell and Gene Therapy Catapult, one of UK’s centers of excellence, has partnered with Japan’s Forum for Innovative Regenerative Medicine to boost their respective stances in the global cell and gene therapy landscape.

UK’s Cell and Gene Therapy Catapult Partners with Japan

HTG, a company that provides molecular profiling services, expects to complete submission of its premarket approval application to FDA for an in vitro gene assay by 2018.

HTG Molecular Diagnostics to Complete FDA Filing for Gene Assay

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

Manufacturing, Gene Therapies