Quotient Sciences has over 30 years of experience developing and manufacturing a breadth of formulations across a range of indications and drug product formats, including oral, inhaled, parenteral, and topical. We also have a depth of expertise in process research and development (PR&D), continuous flow manufacturing, modified release, oral peptides, ADME (absorption, distribution, metabolism, and excretion) studies, radiolabeling, scintigraphy, and pediatrics, as well as the ability to handle highly potent compounds. Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway, from candidate selection to commercial product launch. Our global locations include Nottingham (UK), Reading (UK), Alnwick (UK), Edinburgh (UK), Philadelphia (PA, USA), and Miami (FL, USA).
Drug Substance Synthesis and Manufacturing
We take an agile and flexible approach with our customers’ programs, offering bespoke drug substance synthesis and manufacturing services to help accelerate molecules from candidate selection to clinical proof of concept and onwards towards commercial scale. Our 40+ years of experience in a wide range of synthetic organic chemistry coupled with extensive expertise in flow chemistry, synthetic biology, and biocatalysis can save months of development time for our customers. With our tactical deployment of best-in-class technologies, we minimize chemistry costs and move your drug substance supply off the critical path.
Translational Pharmaceutics® is our unique, flagship platform that accelerates drug development by integrating drug substance, formulation development, real-time manufacturing, and clinical testing. The platform has been proven to save >12 months of development time and reduce R&D costs by up to $100M. It has been used by global pharmaceutical and biotech companies on over 500 drug programs in the past 15 years.
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Quotient Sciences has over 30 years of experience developing a breadth of pharmaceutical formulations for small molecules and peptides across a range of indications. With expertise in simple and complex dosage forms, we have formulated over 1,500 molecules. Our unique track record in clinical research means we know what it takes to develop formulations across the full development pathway. From fit-for-purpose pre-clinical and first-in-human dosage forms to optimized drug products for late-stage development and market, we work with you to develop the most appropriate formulation based on the physicochemical and biopharmaceutics properties of your molecule.
Clinical Trial Manufacturing
Understanding that early-phase clinical testing is a pivotal milestone in the development of your drug product, Quotient Sciences offers clinical trial manufacturing, testing, and certification services designed to meet your individual requirements. Our innovative method of building integrated Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) programs provides a streamlined, flexible approach to drug product supply that reflects your clinical study design and timeline. We understand the time and cost pressures you face during early-phase evaluation and work with you to ensure a rapid, seamless path from development to clinical trial supply.
When you are looking for a partner who is dedicated to Phase I trials and early clinical development, rely on Quotient Sciences for the experience and expertise to seamlessly deliver clinical pharmacology with the highest quality service and speed. We accelerate your molecule from first-in-human to proof-of-concept studies, helping you make critical decisions earlier. Whatever Phase I clinical pharmacology study you require, you can expect a fully integrated program, from study design and start-up to data reporting.
Quotient Sciences is a global player in commercial manufacturing of higher-value, small-molecule drug products for niche therapies that may require smaller batch sizes in the market, including oncology therapies, orphan/rare diseases, and pediatric indications. In addition, our commercial manufacturing facility located in Philadelphia (PA, USA) is designed to handle high-potency compounds. We recognize that speed, flexibility, and agility are essential for establishing a successful commercial product supply chain, so we offer commercial manufacturing solutions tailored to specific product and market needs. Our highly skilled staff, and experience from multiple successful launches, ensure that your project gets the focus it needs to accelerate through registration batches, process validation, and onwards to a successful commercial launch.
At Quotient Sciences, we are experts in the development, validation, and application of bioanalytical assays. Our dedicated team of bioanalytical chemists are globally recognized and have over 40 years of experience in supporting all stages of drug development, from early pre-clinical, through to first-in-human, and onwards to Phase II and III patient studies. At every stage, we help our customers gain a clear understanding of the fate of their drug in the body. Combining our development and validation experience of over 400 bioanalytical assays, along with our integrated service lines, we can ensure that critical decision-making data are rapidly processed, robust, and reliable.
During a clinical study, data is needed rapidly in order to make crucial decisions. By providing data faster, we can provide our customers with earlier interim data and interim pharmacokinetic (PK) reports for on-study dosing and formulation decisions. We understand that on-study changes to early-phase study designs and dosing are frequent, so our strategy for study database design and reporting is built around flexibility and rapid implementation. Our data sciences experts use eSource data collection procedures in our clinical units and a joint eSource/electronic Case Report Form (eCRF) database. Data is available in the study database within hours of collection, ready for remote sponsor access.
Drug Development Consulting
Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry-leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch. Our consultants have a proven track record of cutting across industry silos to reduce the time and cost of development. With hands-on development experience across hundreds of drug molecules and product types, we will help you avoid critical pitfalls, manage risks, and maximize the potential for success.