manufacturing

Process Development

blue_tick

Transgene Vector construct design

blue_tick

Viral vector process development, including transfection ratio optimisation, media reformulation and other critical process parameter determination

blue_tick

Technology transfer for pre-customised processes

regulatory-and-QA

Manufacturing

blue_tick

Manufacture of clinical grade retro and lentiviral vector under GMP as Active Pharmaceutical Ingredients (API) for human gene therapy

blue_tick

Manufacturing process includes Upstream Processing(USP), Downstream Processing (DSP) and Fill Finish in cryobags or vials

tech-platform

Regulatory and Quality Assurance

blue_tick

Experienced regulatory support and advice for Cell and Gene Therapy applications

blue_tick

Support for client audit

Process-Development

Quality Control and Characterisation

blue_tick

In-house developed viral vector quantification assay based on flow cytometry and genome integrated vector copy number by qPCR analysis

blue_tick

Established strategic partnership with an external service provider for comprehensive, validated 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

Project Management

blue_tick

We provide proactive, end-to-end project management from client onboarding to product release and delivery to ensure that timelines and expectations are duly met.