Merck

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.



Related Technical Resources

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Gene therapy development: Grow, purify, formulate

Gene therapy process infographic, from cell culture media to final filtration

Workflow

Viral Vector Upstream Processing

Viral Vector Upstream Processing

Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance 

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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