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Process Development

Optimizing Processes, Accelerating Therapies

AAV

  • Establishing a cost-effective, robust, and optimized production process is crucial for successful GMP viral vector production. At PackGene, our advanced platforms and extensive experience enable us to efficiently optimize both upstream and downstream processes for plasmid and AAV production. We understand that each project has unique processing needs, and our team of scientists and engineers is dedicated to delivering tailored upstream, purification, and formulation processes to meet those needs.

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Key Benefits

  • Optimized production process

    with High-Yield Platform

  • Design of Experiments (DoE)

    Data-driven approach

  • Tailored Solutions

    Customized for your needs

  • Seamless Scale-Up

    Process designed to fit GMP production needs

  • IND-Ready Data

    Documented in electronic lab notebook

Service Details

Efficient process development is a key factor in achieving success through the Investigational New Drug (IND) phase and the entire product development lifecycle. Our Process Development scientists are equipped with the expertise needed to help you meet your process development goals at an affordablecost. By starting your project with PackGene’s GMP process development services, you can save time and reduce costs in the long run. Proper process optimization at early and mid-stage development stages can significantly lower costs for both clients and patients once large-scale production is established. The duration of the process development services may vary depending on the project scope, ranging from weeks to several months.

 

Our Process Development Services Include:

Upstream Process Development

  • Cell line screening and selection
  • Media and feed optimization
  • Transfection condition optimization (including DoE studies)
  • Harvest duration study
  • Lysis and nuclease process optimization

 

Downstream Process Development

  • Clarification filter screening/sizing
  • Resin screening
  • Chromatography condition optimization
  • Dynamic binding capacity determination
  • DoE optimization for yield improvement and impurity removal

 

Process characterization

Analytical Development & QC Services

  • Assay development, qualification, and validation
  • Cell-based potency assays
  • Comparability studies
  • Stability studies

PackGene offers cGMP viral vector process development to ensure that your project meets regulatory standards. For a quote or technical support, please provide your project details and our team will assist you in optimizing your process efficiently.

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Confidentiality Commitment from PackGene:

The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.

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