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.
The solution
Our process chemists, analysts and engineers come together to form a multi-disciplinary team of scientists working with you right through from PR&D to GMP Manufacture.
We apply market-leading expertise, state-of-the-art facilities and best-in-class equipment to design manufacturing processes that reach GMP standards.
To reach your end goals, we take a phase-appropriate approach to establishing optimal manufacturing parameters.
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
