Process research and development
Our process research and development (PR&D) team has over 100 years of combined large pharma experience. The team strives for and maintains excellence in pre-clinical process chemistry R&D, enabling a smoother transition between medicinal chemistry and chemical development.
At the outset of our discovery projects, we encourage our clients to think ahead to the unique demands and challenges of chemical development. It is vital to ensure that pre-clinical supply can be forthcoming at the appropriate stage, and to speed up and reduce the costs of an eventual clinical supply.
Read the Chemistry World interview with David Lathbury on bridging the gap between contract medicinal chemistry and chemical development.
Problem solving capability
Given that most development activities are dependent on an adequate supply of API, it’s important to keep chemical development activities a phase ahead of the requirements of other departments.
Although initial quantities of the API provide the fuel for the development engine, ultimately, it’s the quality of the manufacturing process that is the most valuable output from the PR&D effort.
Chemistry problems are solved more efﬁciently and economically in the laboratory rather than on plants, where costs increase 15-fold. Effective process research & development can therefore be hugely economical, saving time and costs in new product development.
Inefﬁcient chemistry can typically cost a project up to 18 months in lost time, which negatively impacts new product value (NPV) by up to 30%.
The 20-50kg campaign is often the real rate-limiting delivery stage, with a major impact on NPV. This needs to be considered early on in the process – a cornerstone of our PR&D group work with our clients. Your efficiency is our priority.
Our track record
Take a look at an example of our work in this area with the following case study: