Gene Therapy Manufacturing
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.
Reach out to us for more details on our bioprocessing materials and technologies for viral vector production and an expert will respond back to you shortly.
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Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.
Cell culture media filtration prevents bioreactor contamination. Selection of a sterilizing filter, mycoplasma filter, or virus filter depends on process risk. Learn how to select the best filter for your cell culture media filtration.
Upstream process chemicals ensure superior performance of your cell culture process driving cell viability, productivity and critical quality attributes of the drug product.
Browse our high-quality excipients, with solutions for solid, liquid, semisolid, and biomolecule formulation, as well as advanced drug delivery.
Gene therapy development: Grow, purify, formulate
Visit our document search for data sheets, certificates and technical documentation.
Workflow
Viral Vector Downstream Processing
Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs
Viral Vector Formulation and Final Fill
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Viral Vector Characterization and Biosafety Testing
Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability
Viral Vector Contract Development and Manufacturing
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
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Reach out to us for more details on our bioprocessing materials and technologies for viral vector production and an expert will respond back to you shortly.
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