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By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and genetherapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. This can be a devastating outcome when trying again just isn’t possible.
By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and genetherapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.
Rentschler Biopharma has collaborated with Ikarovec for expediting the new genetherapies to treat ophthalmic disease. The company is developing new and differentiated genetherapies for the treatment of serious, but common eye diseases. Cell & GeneTherapy coverage on Pharmaceutical Technology is supported by Cytiva.
Although only a small number of genetherapies have reached the market thus far, the industry is poised to grow quickly over the next few years. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for genetherapies and gene-modified cell therapies alone.
Contract packaging and clinicalsupply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of genetherapies at its facility in Heerenveen, The Netherlands.
The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinicalsupply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,
Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinicalsupply services facility in Philadelphia, in the US, to further support biotech firms developing cell and genetherapies.
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S. About VTX-801.
“This collaboration is an exciting opportunity to complement CSL’s own next-generation mRNA programme with a partner who developed a platform to deliver late stage clinicalsupplies at scale,” said CSL’s chief operating officer Paul McKenzie.
Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinicalsupply and commercial launch.
BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and genetherapy candidates to support the development of its diversified cancer and infectious disease product pipeline.
The companies have also expanded a contract manufacturing agreement with Novartis that will help produce Carvykti for both commercial and clinicalsupply at the New Jersey plant through the end of 2029. 2seventy has been used to the struggles ever since it spun out of genetherapy biotech bluebird bio.
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