Reduce drug substance manufacturing costs by 50% from preclinical to Phase I.
We always strive to produce economical processes for high-purity drug substances that can be rapidly scaled from grams to multi-kilograms. Our highly 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, as well as developing bespoke and innovative solutions for our customers' technically difficult challenges.
We adopt a streamlined approach to developing drug substances at our state-of-the-art facility in Alnwick, UK. This has been shown to reduce manufacturing costs by 50% from pre-clinical to Phase I.
At our facility in Alnwick, UK we have made some significant investments in equipment and technologies to meet the increasing demand for complex small-scale drug substance manufacturing.
We pride ourselves on quickly delivering high-purity drug substances and can rapidly scale up manufacturing at our cutting-edge facility. With more than 40 years of experience in synthetic organic chemistry, coupled with extensive expertise in flow chemistry, synthetic biology, and biocatalysis, we can optimize manufacturing processes and save months of development time for our customers.
A multi-million-pound state-of-the-art building expansion of our Alnwick, UK, facility delivers comprehensive, integrated support for customers bridging from candidate selection to early clinical development and beyond. The newly expanded space features multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and deployment of both batch or continuous flow chemistry technologies.
Creating the foundation for successful API development
Drug Substance API: What our customers say
"Due to the low density and poor flow characteristics of our drug substance, we experienced significant blend and content uniformity issues. By transferring our program to Quotient Sciences, the development team was able to quickly produce demo batches through multiple blending steps and roller compaction using the Gerteis Mini-Pactor. The increase in drug load from 25% to 40% was a significant improvement as we prepared for future Phase II/III trials and this ultimately benefits the patients by reducing the pill burden. We have successfully manufactured several GMP batches of tablets at various doses using a common blend. Quotient Sciences is an outstanding drug development partner with a no-nonsense approach, excellent communication, speed, and robust, easy-to-review documentation, from analytical methods to master batch records."