Drug Product Development & Manufacturing

Quotient Sciences emphasizes the importance of data-driven decisions in early development. Our scientific experts prioritize key API characterization data to recommend the appropriate API form and inform a strategy for preclinical and clinical pharmaceutical development based on the Developability Classification System (DCS).

We anticipate clinical considerations and perform early-laboratory prototyping to de-risk process scale-up and development once a molecule achieves its early clinical endpoints.

We offer a full spectrum of manufacturing and supply paradigms, from traditional large batch manufacturing to bright stock distribution and personalized manufacturing. In addition, our ability to produce small batch sizes facilitates conservation of API and dose flexibility. Fundamentally, personalized manufacturing means the product is made on-demand—only when needed and based on patient requirements. 

We have extensive experience in both traditional formulation development and Translational Pharmaceutics, which combines our drug product and clinical capabilities into a bespoke program that enables formulation decisions based on emerging human data.

We’ve applied formulation flexibility in healthy volunteer trials to a number of applications and therapeutic areas, including oncology where volunteer studies have been conducted to inform “patient ready” formulations in less than half the time of the industry standard. 

We recognize the need to move rapidly and efficiently through clinical development. So we ensure a seamless transition to larger-scale manufacturing and drug product commercialization by leveraging our expertise to scale up manufacturing processes from Phase I to meet the demands of later clinical trials.

Quotient Sciences configures a robust manufacturing and supply chain to meet every customer’s needs and to maintain seamless continuity throughout the development life cycle. We have experience with accelerated approval pathways to guide development programs through registration and process validation. Our manufacturing facilities support batch sizes ranging from less than 1 kg to over 500 kg for solid oral dosage forms, with plans for a 100k sq ft expansion to be online in 2027. We have the expertise and regulatory approval to manufacture your registration and validation batches for the U.S., U.K., Europe, Japan, China, and other global filing markets. Additionally, our experience extends to supporting 505(b)(2) and all post-approval change filings. 

Good Manufacturing Practices (GMP) refer to the guidelines that ensure that pharmaceutical products are produced in a consistent way, maintaining quality standards. Also known as current Good Manufacturing Practices, or cGMP, these practices focus on ensuring safety, quality, and efficacy of drug products over the lifecycle of a drug. Quotient Sciences adheres to cGMP practices at all of our global pharma manufacturing facilities.

From facilities located in the US and UK, Quotient Sciences offers coordinated contract research, development, and manufacturing services (CRO services and CDMO services) as part of one organization. Drug product manufacturing is performed at facilities in Nottingham and Reading, UK, and in the US from our two facilities located near Philadelphia, PA. 

A CRDMO is a contract research, development, and manufacturing organization. A company that offers CRDMO services integrates different areas that would typically be found by selecting multiple vendors.