Pre-clinical process research and development and GMP API manufacture

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. 

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 - delivering up to 10kg of API in a single batch
• Maximize efficiency - de-risking routes and achieving reaction optimization with fewer operator hours
• Improve safety and quality standards – with advanced analytical development and validation and stability studies
• Reduce costs – using statistical techniques such as design of experiments (DoE) we optimize the whole manufacturing process
• Accelerate route to market – discovering the most flexible and agile route to manufacture commercial levels of API

Using our innovative SELECT and green chemicals protocols, we develop scalable, safe, economical and robust processes to manufacture regulatory and non-regulatory intermediaries, registered starting materials (RSMs) and APIs. And, our continuous flow chemistry ensures rapid optimization to reduce the risk of high energy or hazardous intermediaries. 

Combining our full, cross-industry experience, with our broad synthetic chemistry and industrial expertise, we design processes that are fit-for-purpose, including route design and scouting, delivering complex molecules on time, in full, every time.  

Our SELECT process works across all critical areas of GMP manufacturing: 

• Process Safety – toxicity and thermal and reactive hazards checks.   We use desk screening and a range of technologies including DSC, TSu, and isocalorimeters to determine whether a reaction can scale up, keeping manufacturers, end-users and patients safe
• Environmental – assessing environmental and sustainability aspects of API manufacturing including toxicity, waste generation and depletion of natural resources
• Legal – including patent infringement and the use of regulated substances
• Economics – including a thorough appraisal of the selling price, marketing costs, cost of goods sold (COGS) and technology licensing
• Control – evaluating the number and efficiency of purification processes, any non-selective and side reactions and the chemical stability and physical properties of intermediates and reagents
• Throughput – by assessing limiting factors, throughput can be understood and increased

Our experienced analysts have a comprehensive understanding of regulatory requirements and track method development and validation. They work closely with our chemists, ensuring an accurate transfer of knowledge from research stages to PR&D and eventual GMP manufacturing. 

Want to know more about our advanced techniques, including sensitive methods for detecting impurities such as genotoxic compounds? Visit our analytical techniques page. 

Our GMP-compliant facilities are MHRA-accredited and FDA-audited, removing the time and cost required for independent audits.  You can be assured we provide only the highest standard of API production for clinical trials and stability, formulation and toxicology studies. 

Our wide range of vessels and cutting-edge manufacturing equipment produce APIs in gram to kilogram quantities. We are fully equipped with dedicated laboratories and containment systems to manufacture highly potent APIs.

Within our GMP manufacturing services we also provide: 

Using a unique blend of high-end materials characterization, standard chromatographic and elemental/compendial techniques, we meet bespoke requirements for release testing. Along with our standard compendial release test programs, we can create a comprehensive test package. 

For more details on release testing of APIs and their manufacturing constituents, visit our QC release and GMP release testing page.

We offer a comprehensive range of stability studies to establish product performance, required storage conditions and product shelf life, through physical and chemical stability analysis. 

We provide the full range of forced degradation and long-term and accelerated ICH stability studies. 

Find out more about our full stability study capabilities here. 

We provide cleaning validation to assess carryover risk and analytical methods to measure effective residue removal. Our cleaning verification protocols ensure validated processes have been executed effectively.

To discover how you can ensure safety and prevent cross-contamination, visit our cleaning validation and verification page.

Contact our team to find out how.