プロセス開発

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.