Given the complexity of new drug products in the pipeline today, discovery has become an even more challenging, yet exceedingly important, stage of the pharmaceutical lifecycle. Sterling’s comprehensive analytical and medicinal chemistry expertise, and strong focus on scientific collaboration, enables success in the discovery phase while containing costs and adhering to deadlines.

A comprehensive approach to preclinical discovery and development is critical to position projects for long-term success. We pair process development services, including Proof of Concept, Quality by Design, and Design of Experiments, with CMC support, to support the IND process and establish an efficient, cost-effective, and scalable pathway to market. By proactively anticipating and addressing challenges early on, we help our customers mitigate added costs and delays in the long run. In addition, our significant technology transfer (TT) expertise enables us to streamline the transfer process and maximise critical continuity.

As our customers prepare for phase I clinical trials, we help them select an appropriate regulatory starting material (RSM) and discern when it makes sense to utilise GMP and non-GMP processes throughout the project. We support them to quickly develop an appropriate amount of product for trials and generate the necessary regulatory data to enhance their chance of success. Through thorough impurity assessments and other quality-centred approaches, we work to ensure the delivery of pure, high-quality products.

After a product moves through phase I, we continue to accelerate the development of materials for clinical trials, generate critical regulatory data, and seek new ways to enhance efficiency as the product scales up. Process optimisation remains a chief focus of our scientific and engineering teams as we help our clients prepare for phase III, and we continue to evaluate and mitigate impurities and other challenges that may arise.

As many drugs in the pipeline fail to progress past phase II trials, phase III is a significant milestone for our customers and their products. In this critical phase, we work to finalise data generation and process validation, and to prepare in earnest for full commercial manufacture. Scale, efficiency, quality control, integrity, and compliance are all top priorities as we navigate the last phase prior to commercial launch.

After a product is approved for commercial manufacture, we help our customers continually find new ways to enhance efficiency and save costs; ensuring the competitiveness and quality of their product from initial market entry through patent expiry. Our team is committed to optimising processes wherever possible to enhance commercial success. We also provide the required data associated with any process changes to ensure continued regulatory adherence.