Drug Product Development and Manufacturing Services
Achieve your molecule’s next milestone with fit-for-phase drug product formulations, backed by trusted data and the expertise you need to navigate the increasing complexity of small molecule and synthetic peptide therapeutics. Our adaptive approach assures scalable solutions for your molecule’s development, from preclinical through commercial drug product formulation, manufacturing, and supply.
From early development to commercial supply, we provide integrated solutions that streamline pharmaceutical development, ensuring a seamless path from formulation to manufacturing.
Quotient Sciences capabilities
- Preformulation assessment & formulation development
- We prioritise data-driven decisions, using key API characterisation and the Developability Classification System (DCS) to guide pharmaceutical development. Early-laboratory prototyping helps de-risk scale-up and streamline the path from early clinical success to commercialisation.
- Clinical development and accelerating to proof-of-concept (POC) studies
- Our flexible manufacturing solutions range from large batches to more personalised, smaller, on-demand production. Our small-batch capability conserves API and enables dose flexibility, ensuring efficient supply tailored to patient needs.
- Formulation optimisation and validation of product performance in humans
- We specialise in traditional formulation development and our own Translational Pharmaceutics® platform. Translational Pharmaceutics® integrates drug product and clinical capabilities for a streamlined approach to drug development, cutting development time significantly to get to first-in-human trials and into later stages of clinical trials faster.
- Process development, scale-up, and clinical manufacturing for Phase II/III
- Leveraging our expertise to scale up manufacturing processes to meet the demands of later clinical trials, we accelerate the transition through clinical development to larger-scale manufacturing and drug product commercialisation.
- Commercial manufacturing & supply
- With expertise in global regulatory filings, including 505(b)(2) programs and post-approval changes, we ensure efficient manufacture of your registration and validation batches for the US, UK, Europe, Japan, China and other global markets. We specialise in manufacture for paediatrics, rare diseases, and other small-scale niche indications.
