Pre-clinical process research and development and GMP API manufacture

Phase-appropriate approach

To get your active pharmaceutical ingredients (APIs) from development to manufacturing you need to develop safe, scalable and efficient processes.

We take a phase-appropriate approach to process research and development (PR&D) and good manufacturing practice (GMP), combining:

  • Process chemistry experts that collaborate across research, manufacturing and analytical fields to deliver the knowledge transfer you need for right-first-time, on-time delivery
  • Our SELECT approach to developing the most effective process
  • MHRA-accredited and FDA-audited, state-of-the-art GMP manufacturing facilities
  • The very best in analytical equipment and techniques

We interrogate every detail to design manufacturing processes that deliver the maximum benefit to you.

The challenge

Manufacturing safe and efficacious APIs under GMP standards is the main aim for most drug developers. But we all know GMP isn’t just about compliance. It’s about delivering high yields, quickly and safely at the lowest costs. All while maintaining consistent high-quality outputs that meet exact specifications.

In early research and development stages, low yields and slow processes are the norm but when you’re scaling up or out to reach kilogram level quantities for clinical trials, this isn’t what you want. Designing the most effective route to high-yield manufacturing must start in the PR&D stage and be accompanied by data that proves the process and ensures reproducibility.

In all processes, we find the safest and most effective ways to:

Increase yields

Increase yields – delivering up to 10kg of API in a single batch

Maximize efficiency

Maximize efficiency – de-risking routes and achieving reaction optimization with fewer operator hours

Improve safety and quality standards

Improve safety and quality standards – with advanced analytical development and validation and stability studies

Reduce costs

Reduce costs – using statistical techniques such as design of experiments (DoE) we optimize the whole manufacturing process

Accelerate route to market

Accelerate route to market – discovering the most flexible and agile route to manufacture commercial levels of API

Want to find out more?

Our multi-disciplinary teams mitigate risk by employing knowledge, foresight and thought leadership to all our client’s diverse programs enabling the highest chance of success. Get in touch to find out how we can support you.