Manufacturing

Articles

The Committee for Medicinal Products for Human Use of the European Medicines Agency presented a positive opinion of bluebird bio’s SKYSONA (elivaldogene autotemcel, Lenti-D), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy, an X-linked metabolic disorder.

bluebird bio’s One-Time Gene Therapy for CALD Receives Positive Opinion from CHMP

Univercells will introduce the intermediate capacity scale-X carbo system to NIBRT’s facility for hands-on demonstration and training in CGT.

Univercells and NIBRT Team Up to Address Needs for Cell and Gene Therapy Training 

VectorY, a Netherlands-based biotechnology company, has been selected as the European winner of MilliporeSigma’s 2021 Advance Biotech Grant Program. 

MilliporeSigma Announces European Winner of its 2021 Advance Biotech Grant Program

Charles River plans to enhance its gene therapy capabilities through the acquisition of Vigene Biosciences. 

Charles River to Acquire Vigene Biosciences for up to $350 million

Mark White, PhD, is associate director, Biopharma Product Marketing, at Bio-Rad Laboratories.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Using ddPCR to Detect Mycoplasma Contamination

Biogen and Capsigen have entered into a strategic research collaboration to engineer novel AAV capsids to deliver gene therapies that address the underlying genetic causes of various central nervous system and neuromuscular disorders. 

Biogen and Capsigen to Develop Novel AAV Capsids for up to $1.37 Billion

Originally established in the 1970s as a fetal bovine serum supplier, Fujifilm Irvine Scientific continuously proved its strength in the cell culture solutions space.

Fujifilm Irvine Scientific Celebrates 50 Years of Providing Cell Culture Media Products and Services

NIH reported that an investigational gene therapy developed by researchers from the University of California, Los Angeles and Great Ormond Street Hospital in London can restore the immune systems of infants and children who have severe combined immunodeficiency due to adenosine deaminase deficiency. 

Research Shows Gene Therapy Restores the Immune Systems of Infants and Children with Rare Immunodeficiency

ViroCell will supply viral vectors and gene modified cells, to academic and corporate clients, for translational cell and gene therapies going into clinical trials.

ViroCell Launched in the UK to Manufacture Viral Vectors

Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe.

Manufacturing, Gene Therapies