Process Development
Transgene Vector construct design
Viral vector process development, including transfection ratio optimisation, media reformulation and other critical process parameter determination
Technology transfer for pre-customised processes
Manufacturing
Manufacture of clinical grade retro and lentiviral vector under GMP as Active Pharmaceutical Ingredients (API) for human gene therapy
Manufacturing process includes Upstream Processing(USP), Downstream Processing (DSP) and Fill Finish in cryobags or vials
Regulatory and Quality Assurance
Experienced regulatory support and advice for Cell and Gene Therapy applications
Support for client audit
Quality Control and Characterisation
In-house developed viral vector quantification assay based on flow cytometry and genome integrated vector copy number by qPCR analysis
Established strategic partnership with an external service provider for comprehensive, quality viral vector characterisation including but not limited to:
Bioburden
Mycoplasma
Endotoxin
Adventitious agents
Residual whole cell protein and DNA
Residual plasmid DNA
Residual benzonase
Replication competent virus
Project Management