Viral Vector Process Development
Manufacturing Science & Technology (MSAT)
The MSAT group are instrumental in driving improvement into delivery processes. They work in collaboration with our process development scientists, manufacturing production teams and our clients to achieve continuous improvements in the way that we manufacture viral vector. This team works closely with the other teams to ensure that the new processes and equipment are deployed to optimise activity at GTVF.
Our MSAT team sets our client projects up for success with the following activities:
- Manufacture of engineering batches at scale requested
- Provision of GMP-identical material for pre-clinical work
- Plasmid assessment, procurement and ratio optimisation
- New assay development, e.g. bespoke titre assays
Process Development (PD)
The Process Development team is dedicated to the continuous development of process. The team is on hand to support requested client process development work alongside Production and Quality, and is focused on developing our own platform process, with a particular focus on:
- Innovating the next generation of processing, (e.g. use of suspension cells and an animal component free system)
- Upstream optimisation (e.g. adopting new technology, evaluating improved cell lines, optimising transfection methodology)
- Downstream optimisation (e.g. filtration and purification optimisation)
- Improving efficiency and reliability to deliver higher productivity batches to enable larger clinical studies
- Enabling process control systems for better consistent output: clarification, bioreactors, chromatography, TFF systems
- Developing single use and closed loop processes
Analytical Development (AD)
The Analytical Development team are on hand to ensure that client projects have any development work required for titre development - PCR, ELISA, Flow. Alternatively, clients can tech transfer in their own assays. Working in harmony with PD, AD aims to focus on:
- Characterizing yields (empty: full ratios, via genomic and capsid titre)
- Characterizing and controlling impurities (HCD, HCP)
- Introduction of modern analytical platforms including ELISA, PCR, Blots
- Supporting client projects with analytical assay development
- Transfer to QC for product batch release
Get In Touch
Contact us to discuss your lentiviral vector, retroviral vector, and adeno-associated viral vector GMP manufacturing needs: