Gene therapies offer an unprecedented potential to treat and cure countless diseases and conditions for which patients have no or limited treatment options. Hundreds of gene therapies are currently in development around the world, being advanced by both early-stage companies and established industry leaders.
Successful development of a gene therapy requires expertise that differs from the production of other biologics such as monoclonal antibodies. Viral vector manufacturing and specialized testing capabilities are unique to this modality and just two areas that can determine the success of a candidate gene therapy. The lack of established process templates, evolving regulatory guidelines, and the need to meet accelerated timelines put additional pressure on gene therapy manufacturers to get it right the first time.
Given the remarkable opportunities and challenges presented by gene therapies, alliances with experienced technology partners or contract development and manufacturing organizations (CDMOs) are essential to ensure successful process development, scale-up, manufacturing, and regulatory compliance.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for classic and novel therapies, but also helps them get to market faster and simplify regulatory challenges.
Scaling up viral vector production using adherent cell culture systems is challenging. Learn how suspension cell culture systems benefit large-scale bioprocessing.
You’ve created a gene therapy with the possibility to help patients. But the development and manufacturing of your gene therapy, how it’s developed, produced and approved, are still being outlined.
Despite notable clinical and even commercial success, the demand for gene therapies still outweighs supply.
How MilliporeSigma and SaudiVax are working together to help patients in the Middle East and North Africa access the benefits of advanced medicine.
Looking at the current state of cell and gene therapies (CGTs), it is clear they have brought major changes to the biopharmaceutical landscape.
With rapid market growth and inspiring stories of success, gene therapies boast a promising future for manufacturers and patients alike.
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