eXmoor’s team of highly experienced Cell & Gene Therapy consultants understand how to develop, manufacture and commercialise Cell & Gene Therapy products.  Their unparalleled experience in developing and defining Chemistry Manufacturing Controls (CMC) strategies maximizes the chances of getting your product in to the clinic on time and within budget.

Our Capabilities

Product & Process Development Strategy

We can define your roadmap to take you to where you want to go, whether its a proof of concept study, early phase clinical trial or all the way to commercial.

Process Evaluation

We use our proprietary evaluation toolbox to assess your current product or process and provide a comprehensive report highlighting areas for further investigation.

Comparability Studies

We understand that changes are often required to a manufacturing process as you progress through clinical trials, and we can provide the right guidance for demonstrating comparability when this is required.

GMP Compliance

We ensure that everything from materials to equipment, cell lines to Quality Management Systems are all GMP compliant and appropriate to meet regulatory requirements.

Analytical Development Strategy

We can define and develop your analytical strategy in a phase appropriate way including all in-process and release assays.

Cost of Goods Modelling

We perform in depth Cost of Goods analysis to your specific process or program of products to determine key drivers for cost reduction and support commercial decisions.

Program or Portfolio Analysis

We can use our proprietary evaluation tools to assess multiple products in your portfolio, identify optimum development opportunities, help prioritise decisions and recommend effective program management.

Build or Buy Modelling

We use our experience to assess your decision to build or buy manufacturing capacity and we ensure the criteria for ultimate selection fits with your organisation’s overall business objectives.

Interim Roles

Our Senior Consultants can step in to interim roles as companies go through periods of growth or change to ensure stability and expertise when it is most needed.

CMC Strategy

We facilitate the definition of your CMC strategy and comparability analysis with prioritisation based on risk and cost analysis of the process.

Commercialisation Strategy

We can define your commercialisation strategy that fits with the need to supply different geographic locations and assure worldwide supply.

Qualified Person

Our QPs combine experience across all cell and gene therapy modalities and are currently named on the license for 8 facilities in the UK.

Due Diligence Assessment

We support companies and investors looking for due diligence preparation.  We can provide insights in to the value of an opportunity and also the risks and costs.

Landscape Scanning

We can determine the current market and project future needs based on your product or service.

Tech Transfer Planning

We can provide technical guidance and project management for the transfer of processes to a Contract Manufacturing Organisation (CMO).