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.
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.
PackGene can provide cGMP AAV process development for your project. Please provide certain project details to get a quote or technical support from PackGene.
What is the source of PackGene cell bank?
PackGene’s h293 cell bank is officially authorized for commercial use.
What is the AAV output for a single batch fermentation?
PackGene offers single batch fermentation at several volumes, including: 2L, 7L, 25L, 50L, and 200L. AAV yields for each of these production volumes varies across AAV serotypes. As an example, AAV9 is a medium to high-yielding serotype, and expected yields for AAV9 are as follows:
|Expected yield for AAV9|
What method is used to determine the empty shell rate for AAV samples?
Viral empty shell rate can be determined using several techniques including anion chromatography HPLC, Analytical Ultracentrifugation (AUC), Transmission Electron Microscopy (TEM), CyroTEM, or VG Titer/Capsid titer. AUC, TEM and CyroTEM are typically not suitable for quantitative quality control determinations and thus PackGene’s standard method for empty shell rate determination is anion chromatography HPLC. PackGene can provide additional CyroTEM and AUC analytical services to serve as a secondary verification of the results derived from anion chromatography HPLC.
How are GC/ml and vg/ml related to one another, and how does PackGene determine GC/ml for AAV products?
The terms genome copies per ml (GC/ml) and viral genomes per ml (vg/ml) are interchangeable and equal in most cases. At PackGene we may test GC by both qPCR and ddPCR. Testing by qPCR involves the use of a calibration standard while ddPCR may use optional reference products. Measurements by qPCR are more likely to be influenced by inter-lab and inter-operator variables, and ddPCR generally shows lower %RSD precision. Typically, GC is determined by qPCR during process exploration phase and for intermediate products while the GC of final products is more often determined by ddPCR.
Plasmids GMP Services
Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way
AAV GMP Services
Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies
PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.