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Pharmaceutical Technology interview with Paul Quigley, Head of Production, Drug Substance on timeline acceleration with drug substance and drug product

Rapidly Accelerate Development Timelines: The Integration of Drug Substance & Drug Product Development

Featured Contributor: Paul Quigley, Head of Production, Drug Substance

From preclinical through clinical development to commercial products, no other pharmaceutical drug development company offers it all at one organization. Paul Quigley, Head of Drug Substance at Quotient Sciences, says that the Company's fully integrated drug substance, drug product and clinical testing capabilities have been proven to dramatically reduce a new substance’s time to market.

Q: How long have you been in the drug substance space?

A: Paul Quigley: I have been in the pharmaceutical industry, for over 20 years, working for pharmaceutical and contract services organisations. In 2016, I was the second hire into Arcinova, a UK-based drug substance and drug product services provider which was acquired by Quotient Sciences in February 2021. In this role, I led the expansion of the radiosynthesis and drug substance development and manufacturing teams.

Q: What do you see as the primary challenges facing drug developers today when it comes to drug substance & drug product development?

A: In today’s climate, drug developers are faced with tight timelines for complex projects involving high risk. There is a need for organisations that can manage both drug substance and drug product in parallel, developing manufacturing processes that are controllable, robust and scalable. The scale component is especially important as de-risking this ensures that when a product is developed and supplied to clients, there is no need for re-running studies as they move downstream through successive clinical stages. This saves drug developers time, money and ensures significant value to the ultimate product.

Q: What Contract Development and Manufacturing Organisation (CDMO) services does Quotient Sciences provide that help customers overcome drug development hurdles and expedite timelines?

A: Quotient is a fully integrated pharmaceutical development and manufacturing organisation that is involved from the preclinical phase through to commercial launch. At the front end, we are experts in candidate development, designing synthetic routes for radiolabelled and non-radiolabelled drug substances, with a team that has hundreds of years of combined experience.

We have extensive preclinical, solid-state characterization, formulation development and clinical trial manufacturing services and have the ability to run these services in parallel with our drug substance process research and development and scale-up operations – helping sponsors to transition from preclinical grade materials through to GMP (Good Manufacturing Practice) drug substance and drug product for clinical use and then onward to commercial drug product manufacturing.

Our team brings extensive scientific and project management firepower, coupled with a simplified supply chain, ensuring rapid delivery of materials and data packs, all from a single organization.

The tight integration of drug substance, drug product development and clinical testing services, breaks down traditional industry silos, enabling chemists, biopharmaceutics experts and formulators to work together to efficiently optimize the drug substance manufacturing process and in parallel, design and manufacture a dosage form suitable for each stage of development.

This integration under one organization allows for seamless coordination and knowledge sharing, ease of material transfer, and a reduction in overall project risk.

Some examples of how this integration demonstrates time savings include the overlapping of method development, where customers can be provided with a drug substance analytical method which can then be used as a basis for their drug product method.

For very early-stage programs, preformulation activities can begin quickly after the first few grams of non-clinical drug substance are produced. And when it comes to regulatory filings, we can begin to prepare documentation for sponsors while drug substance and drug product activities are ongoing, adding in data in real-time to their IMPD/IND (Investigational Medicinal Product Dossier/ Investigational New Drug Application).

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