Manufacturing

Articles

The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020. 

NJII Launches Cell and Gene Therapy Manufacturing Center

The new cell-line producing platform enables fully scalable production of high-performance adeno-associated virus vectors.

Cevec Launches ELEVECTA Platform for AAV Vectors for Gene Therapy

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

MilliporeSigma Adds Viral Vector and Gene Therapy Capacity


Daiichi Sankyo has entered into a partnership with Ultragenyx Pharmaceutical for the use of Ultragenyx’s proprietary AAV-based gene-therapy manufacturing technology.


Daiichi Sankyo Enters Partnership with Ultragenyx for a Total of $225 Million

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

Thermo Fisher Scientific Invests $800 Million into New Capabilities and Capacity

Agnes Shanley is senior editor of Pharmaceutical Technology.

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

Inside FDA’s New Gene and Cell Therapy Guidances

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

Optimizing Process Development for Emerging Therapies

The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.

Investments Inject Growth in Cell and Gene Therapies

The last year has seen intense investment activity into raising cell and gene therapy manufacturing capacity.

Manufacturing, Gene Therapies