Viral vectors
DS to GMP drug product in under 6 months.
Purpose-built facilities, experienced scientific teams and robust GMP manufacturing platforms for AAV and LVV — from process development through commercial supply.
Our approach
Manufacturing designed with commercialisation in mind
Commercially-minded scientists
Seasoned teams drive development and manufacturing with a scale-up mindset.
Quality-first materials
Raw materials & consumables selected on quality, compliance and cost.
Fast product release
State-of-the-art analytical platforms accelerate release testing.
Standardised documentation
Process development & GMP documentation aligned to global standards.
CMC regulatory support
Extensive support throughout your project lifecycle.
MCB / WCB services
Ready-to-use QuaCell™ WayneLVpro™ HEK293 cell banks with full characterization.
Process
Upstream & downstream — scalable & reproducible
Upstream
- DOE-based small-scale optimisation
- Flask process development
- 2–10L pilot batches
- Engineering runs at 200L and 500L
- GMP manufacturing at 200L and 500L
- Serum-free HEK293 triple-plasmid co-transfection
Downstream
- Affinity, IEX and multi-modal chromatography
- Bead-based, membrane adsorption & monolith technologies
- Single-use flow path · dedicated systems
- Automated chromatography methods
- UF/DF for all scales
- Custom single-use centrifugal collection
500L
Max bioreactor
1×10¹²
vg/mL upstream
< 6 mo
DS → GMP DP
1,600
vials per fill
Analytical & QC
Platform assays adapted to each program
In-process & release
In-process monitoring throughout manufacturing, on-site GMP QC labs for DS/DP testing, batch release and compliance monitoring against evolving regulations.
Comprehensive support
In-house stability, reference standard generation, characterization & comparability, method development, qualification, validation and optimisation of transferred methods.