Manufacturing, Cell Therapies

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

The long-term agreement gives CombiGene the authority to manufacture and commercialize the drug if it is approved after clinical studies.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

The new incubators are set to be operational starting in 2021.

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 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.

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

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.

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. 

Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.

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

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.