Manufacturing, Cell Therapies

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

AskBio’s acquisition of Synpromics will improve the efficacy of its adeno-associated virus gene therapy vectors.

The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Researchers in China are playing a role in advancing gene therapy development.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Kite, a Gilead company, announced plans to build a new facility for the development and manufacturing of the starting material for the production of cell therapies, viral vectors.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.

GE Healthcare launches Chronicle GMP-compliant automation software for cell therapy manufacturing.

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.

In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.