cGMP Process Development
Establishing a cost-effective, robust and optimized production process is essential for GMP AAV production. With PackGene’s advanced platforms and extensive experience we will efficiently optimize your production processes including upstream and downstream process development required for plasmid and AAV production. At PackGene we understand that each customer and each project may have unique processing requirements and our virologists and engineers are committed to deliver robust fermentation and purification processes based on your specific requirements.
Process Development Services
The development of an efficient manufacturing process is critical for the Investigational New Drug (IND) phase through clinical phases. All of the materials needed for clinical trials must be produced efficiently, safely, and consistently – especially when atypical manufacturing conditions are required. Unfortunately, high quality process development often requires extensive experience and may be quite costly; thus proper process development may be overlooked by independent researches and startup companies where resources must be managed carefully. PackGene Process Development scientist have the experience needed to help you achieve consistent GMP production at a fair cost.
Proper Process Development at the early and middle product development stages can ultimately reduce costs for both clients and patients as large-scale production cycles are established. Starting your project with the help of PackGene’s GMP Process Development services will ultimately save time and cost. The time required for process development services may depend on the scope of your project and can range from weeks to a few months.
PackGene provides GMP process development services
- Upstream process development including fermentation volume, expression, and materials, optimization.
- Downstream process development including recovery, purification, and concentration optimization.
- MP QC services including assay development related to fast service safety, potency, purity, and identity.