For further analysis and evaluation of samples, CTM can offer the rapid production of either crude or purified product from multiple clones provided from your laboratory.
Process development and scale-up are essential elements in the preparation of moving towards GMP production. The staff at CTM has many years experience of understanding the requirements of this process and ensuring regulatory compliance with later GMP production.
Prior to GMP production there is often a need for material to be produced in bulk for additional in-house proof-of-concept studies. CTM can produce this material on your behalf to documented systems.
In order to smooth the transition to a future GMP compliant process, many companies find it beneficial to obtain an early independent opinion of the current status of their upstream and downstream methodologies.
The majority of companies contract-out their initial GMP production to specialist companies (CMOs). The selection of an appropriate vendor is essential if your project is to move forward in a timely manner. CTM is able to discuss your requirements with reputable companies and to make recommendations as to the partner of choice.
Once a CMO has been selected, the next critical stage is the transfer of the production process to the CMO. If handled well, by experienced staff, both the potential time, and therefore the cost, of this stage can be reduced. Again CTM has staff well experienced in this process.
By handling the project management stage, CTM can ensure that realistic timescales are set in collaboration with the CMO
and also that there is adherence to these timescales.
An overview of the ‘Product Pathway: From Discovery to Clinical Trials’ and CTM’s position within it, is shown on the next page.
