Manufacturing, Cell Therapies

Genezen Laboratories has broken ground on a new current good manufacturing practice (CGMP)-compliant lentiviral vector production facility.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing

Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.

Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Under the terms of the agreement, Thermo Fisher will construct and operate a 44,000-ft2 cell therapy development, manufacturing, and collaboration center on UCSF's Mission Bay campus.

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

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

Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

Cellares has raised $82 million to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies.

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

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

Catalent plans to add cryogenic capabilities to its facility in Philadelphia, which will strengthen its ability to cryogenically preserve cell therapies and other biological materials.

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Growth in cell and gene therapies puts pressure on the raw materials supply chain.

The companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process.

Sana will be authorized to use the iPSC cell lines from FUJIFILM Cellular Dynamics for the research and development, clinical and commercial manufacture, and commercialization, of the cell therapies derived from the lines.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

Under the terms of the acquisition, OXGENE will become a fully owned subsidiary of WuXi Advanced Therapies, WuXi AppTec’s cell and gene therapy contract testing, development, and manufacturing organization business unit.

The site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.