Process & Analytical Development

eXmoor has an extensive team of process development engineers and scientists with vast experience across multiple technologies and modalities.

Our bespoke and flexible Process and Analytical Development services apply risk-based and design-of-experiment (DoE) tools to prioritise and structure experimental work.  Our work is focused on GMP compliant processes with the end game of a commercially viable, GMP manufactured product.

All processes developed can be seamlessly transferred to our co-located GMP manufacturing facility, to save time and cost in getting to the clinic.

We are experienced with AAV serotypes 2, 3, 5, 6, 8, 9, 10 + proprietary serotypes.  We offer a full range of services for upstream and downstream process development to either compliment you own process development activities or we can provide a complete package of work to achieve phase appropriate GMP compliance.

Typical services may include cell bank generation, upstream and downstream optimisation, equipment and materials comparability, formulation studies and material generation.

We offer a full range of services for upstream and downstream process development to either compliment you own process development activities or we can provide a complete package of work to achieve phase appropriate GMP compliance.

Typical services may include cell bank generation, upstream and downstream optimisation, equipment and materials comparability, formulation studies and material generation.

We are experienced in allogeneic and autologous cell therapy development, including the growth, differentiation and manipulation of iPSC, MSC and immune cells.

We have the capabilities for adherent cell and organoid culture up to 72,000cm2 and suspension bioreactor culture from 250ml to 50L.

 

We specialise in small scale, personalised batches of RNA therapeutics (up to 500 vials).  Using a toolbox approach to our manufacturing process we have the ability to produce cost effective, low volume RNA.

eXmoor can qualify and run a wide range of assays for different modalities including identity, viability, purity, pluripotency, phenotype, transduction, infectious titre, residuals, Vector Copy Number (VCN), mycoplasma, particle size and more.

Our technologies include ddPCR, qPCR, HPLC, Dynamic Light Scattering (DLS), metabolite analysis, automated cell counting and cell cycle analysis,  fluorescent and luminescent plate-based assays, flow cytometry and cell imaging.

We also offer bespoke assay development.