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cGMP Process Development

The establishment of cost-effective, robust, and optimized manufacturing process is critical for GMP AAV Products. PackGene has rich experience and advanced platform for optimizing your production process, including upstream and downstream process development services necessary for plasmid and AAV production. Thinking that each client might have particular processing requirements, our virologists and engineers promise to deliver a robust fermentation and purification processes for different AAVs products.

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Process Development Services

The development of an efficient manufacturing process is critical for IND to clinical phases, All the materials needed for clinical trials must be produced efficiently, safely, and consistently including in typical manufacturing conditions. Process Development is often by-passed by many researchers and start-up firms for its high costs and experience demanding. PackGene Process Development services help achieve consistent GMP production and reduce costs for both clients and patients.
Start your project with the help from PackGene’s GMP Process Development services could be a smart step to save your time and expenses with quality standards. The amount of time required for process development services may depend on the scope of your project and could be weeks to a few months.

PackGene provides GMP process development services

  • The upstream process, involving procedures of fermentation volume, expression, and materials, etc.
  • The downstream process, involving procedures of recovery, purification, and concentration of the final product.
  • The GMP QC services, involving assay development related to product safety, potency, purity, and identity.
PackGene can provide cGMP AAV process development for your project. Please provide certain project details to get a quote or technical support from PackGene.
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