Drug Substance Development & Manufacturing

Tailored drug substance services to suit your needs. Learn about our drug substance synthesis and manufacturing capabilities.

Reduce drug substance manufacturing costs by 50% from preclinical to Phase I.

The First Kilograms of GMP Drug Substance

Learn more about our capabilities in our latest whitepaper.

At a Glance

 

We strive to produce economical processes for high-purity drug substances that can be rapidly scaled from grams to multi-kilograms and offer innovative solutions when it comes to synthesizing and manufacturing challenging APIs. Our experienced chemistry, analytical, and drug development teams can support route selection, process development, critical process parameter (CPP) definition, experimental design (DoE), and impurity tracking/control. 

Our expertise and integrated approach to developing drug substance API at our state-of-the-art facility in Alnwick, UK has been shown to reduce manufacturing costs by 50% from pre-clinical to Phase I.

At our Alnwick, UK facility, significant investments in equipment and technologies have allowed us to meet increasing demand for complex small-scale drug substance manufacturing. This has included a recent upgrade for Annex 1 compliance for sterile manufacturing. 

We pride ourselves on quickly delivering high-purity drug substance and can rapidly scale up manufacturing to support your needs. With more than 40 years of experience in synthetic organic chemistry and extensive expertise in flow chemistry, synthetic biology, and biocatalysis, we can help you optimize manufacturing processes and save months of development time.

A recent, multi-million-pound expansion of our Alnwick, UK, facility delivers comprehensive support for drug substance manufacturing. Our expanded space features multi-purpose capacity of up to 15 GMP reactor streams with volumes ranging from 5 to 150 liters and deployment of both batch or continuous flow chemistry technologies. 

Creating the foundation for successful API development

Dr. Gareth Jenkins
Drug Substance, Gareth Jenkins

Innovative Trends in Continuous Drug Substance Manufacturing: The FlowInova Platform

By: Dr. Gareth Jenkins Download Whitepaper
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