cGMP Process Development
Establishing a cost-effective, robust and optimised production process is essential for GMP AAV production services. PackGene has extensive experience and advanced platform to optimize your production process, including upstream and downstream process development services required for plasmid and AAV production. Considering that each valuable customer might have particular processing requirements, our virologists and engineers are comitted to deliver robust fermentation and purification processes for different AAVs products.
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 undertypical manufacturing conditions. Process Development is often overlooked by many researchers and start-up companies for its high costs and lack of experience. PackGene Process Development services help achieve consistent GMP production and reduce costs for both clients and patients.
Starting your project with the help of PackGene’s GMP Process Development services is a wisestep to save your time and money with quality standards. The 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 fast service safety, potency, purity, and identity.