Recent investments increased total batch reactor capacity by 7x and maximum batch size by 6.5x
ATEX area for industrial-scale solvents handling, and optimized materials flow with centrally located dispensary and storeroom
Flexible space for flow chemistry, supporting the integration of novel and differentiating technologies
Industry 4.0 by design, with a control system ready for PAT integration and data modelling
A look at our facility: drug substance manufacturing in Alnwick, UK
Significant investments have been made to expand our Alnwick, UK facility over the past few years, enabling both batch and continuous flow manufacturing and Annex-1 compliance for aseptic manufacturing.
Our expanded space features multi-purpose capacity of up to 14 GMP reactor streams with volumes ranging from 5 to 150 liters and deployment of both batch or continuous flow chemistry technologies. This allows us to flexibly manufacture GMP API batches at the quantities you need for your early stage drug programs.
Our industry 4.0-ready, GMP drug substance facility is also equipped with CFR21-compliant data handling and real-time process control, facilitating advanced multivariate analysis to ensure the highest standards of quality and regulatory compliance at every stage of production.
Offering the flexibility you need for drug substance development and manufacturing throughout early development:
Customised, scalable API development & manufacture
Recent investments in advanced technologies and equipment help meet the demand for scalable drug substance manufacturing. Our expert production teams and PR&D chemists collaborate to deliver customised drug substance synthesis and manufacturing services to match the needs of your drug program at every stage.
Agile analytical & CMC regulatory support
Our integrated analytical teams specialise in developing and validating phase-appropriate methodologies, embedding quality specifications and process control strategies from the start.
Throughout each study, our chemists work alongside regulatory support and development analysts to ensure quality controls are seamlessly included in manufacturing processes.
Expertise handling a range of complex APIs
We specialize in handling of a variety of complex drug substances while ensuring safe, efficient, and scalable processes.
- Heterocyclic compounds
- Carbohydrates
- Controlled substances including cannabinoids, ketamine and tryptamine
- Potent molecules (1-10 µg/m³)
- OEB 4 Handling (PBLEC 5 at g scale)
- Bioburden-controlled API for sterile drug product manufacture
Integrated PR&D & solid-state development
We bring together experts in analytical development, solid-state chemistry, and process R&D—all working in real-time to deliver safe, regulatory-compliant, and economically-efficient drug substance.
Our philosophy focuses on getting your API right the first time, identifying optimal salt forms and polymorphic landscape early, to derisk your process and path to the clinic.
Flexible API scale up and data rich programs
We prioritize process sustainability. By collecting comprehensive data at every stage, we ensure better decision-making and a more efficient development process to accelerate your path through early development. Where appropriate, we use design of experiments, parallel reactors, and computational modelling to shorten development timelines.
A holistic approach to drug substance synthesis and manufacturing
We minimize risks by holistically considering the synthetic approach, molecule properties, and regulatory strategy—ensuring a smooth path to the clinic.
Our integrated capabilities in drug substance process research, development, and manufacturing are the foundation of our approach. At our state-of-the-art facility in Alnwick, skilled PR&D chemists work closely with development analysts and GMP production teams to embed quality controls throughout the entire manufacturing process.
Our skilled chemists develop robust, economic, and regulatory-compliant scale-up processes to move your drug substance forward. We are experts in rapidly scaling-up drug substances to multi-kilogram quantities, supporting both direct client supply or onward drug product manufacture.
What our customers have to say about working with us:
PLACEHOLDER FOR CLIENT TESTIMONIAL Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nunc consectetur, turpis id mattis viverra, velit libero iaculis sem, ac ultricies justo nisl et tellus. Nullam vel velit sit amet nulla pharetra tincidunt. Maecenas at consectetur turpis, et mattis dui. Duis ornare nisi sed urna eleifend, at egestas ipsum mollis.
