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, says that Quotient’s fully integrated drug substance, drug product and clinical testing capabilities have been proven to dramatically reduce a new substance’s time to market

How long have you been in the drug substance space?

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.

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

Paul Quigley: 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.

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

Paul Quigley: 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).

What are the key levers in drug substance development and manufacture, which can impact drug product formulation and manufacture?

Paul Quigley: Our drug substance development focus is on process velocity and economy, product purity, process scalability and safety. At Quotient, drug substances can be scaled to multi-kilogram quantities to support direct client supply, or as part of a fully integrated in-house drug substance/drug product package using our Translational Pharmaceutics™ platform, to support clinical trial or full-scale drug product commercialisation programmes.

Success in drug substance and drug product development is aligned with the understanding and controlling of key impurities in the process and ultimate drug substance, from a form control, consistency, and clinical outcomes perspectives. We bring a strong legacy of analytical sciences, with extensive experience, state-of-the-art technologies & facilities and wide-ranging capabilities in analytical method development, bioanalysis, & microbiology.

Our full-cycle knowledge begins with the ability to assist with lead optimisation, providing a druggability assessment to ensure that the right compound is developed from the start – playing to our strengths in candidate selection, salt screening, polymorph screening and drug development enhancing the likelihood of clinical success.

Does Quotient Sciences have drug substance (API) production capability, or does it have to go to external sources?

Paul Quigley: We have extensive in-house drug substance synthesis and manufacturing capabilities, and are currently investing more than US $8m in a major expansion to support growing customer demand. By Q2, 2022 we will have a range of GMP batch and flow reactor capabilities running from 5- up to 150lt scale with typical batch sizes up to 15kg.

Are delays in Active Pharmaceutical Ingredient (API) supply a large factor in a CDMO’s development timeline?

Paul Quigley: At traditional, more siloed CDMOs, the lack of joined-up or integrated thinking can hamper the overall drug substance development and supply timeline. A major reason why drug product CDMO’s or clinical Contract Research Organisation’s (CROs) experienced delayed timelines is due to the late delivery of API from the sponsor or their 3rd party CMO (Contract Manufacturing Organization).

At Quotient, we can manage the drug substance and drug product supply chain in-house – being fully accountable to ensure the API is supplied on time – at the right quantity and quality. With many colleagues experienced in manufacturing at larger scales, we know what a process should look like for downstream success.

Small changes to a process later on in the clinic can have a major impact on the impurity profile, particle size and physical form (polymorph etc.), which can have an impact on and negate formulation development.

Our phased approach to drug substance manufacture reduces the risks in the scaleup process and feeds into polymorphism, salt selection, preformulation and tox studies. We control the end-to-end process from PR&D (product research and development) through to formulation development, to eliminate this risk.

Can you talk briefly about a successful and quick-to-market drug that Quotient Sciences has helped develop?

Paul Quigley: We recently worked with the US National Institute of Health (NIH) to support the development of a fully scalable drug substance manufacturing process, using new continuous manufacturing technologies.

This technology took out a major chunk of manufacturing cost, is fully scalable, and most importantly, took months out of the drug substance delivery schedule for our client at a critical time for them.

We also leveraged our comprehensive and integrated suite of oral and IV (Intravenous) formulation development and manufacturing solutions on this project, which ultimately enabled the NIH to achieve a successful IND in a reduced timeline.

What key benefits can clients expect when partnering with Quotient Sciences on a fully integrated Drug Substance and Drug Product Development and manufacturing projects?

Paul Quigley: Customers from small biotech firms to large multi-national pharmaceutical companies will experience many benefits from our fully integrated drug substance and drug product services. For biotech firms, leaner outsourcing models can provide them with clinical support packages that have been designed by people who know exactly what big pharma value and expect, making for a smoother transition and a higher value for the transaction.

For large pharma customers, having seamless integration of drug substance and drug product services under a single organization allows for ease in material transfer, reduces overall risk and ultimately shortens their time-to-clinic to know whether or not they have a successful formulation to move forward with.

Quotient has made significant investments over the years to support these integrated programs. Our heritage in drug development and the attention we pay to what our clients need mean that what we develop is perfectly aligned with what our clients want. And it goes without saying that agility and speed are key – our clients want us to move quickly to achieve their timelines – but also we are very aware that ultimately patients are waiting for new medicines.

We are focused on generating high-quality data packages as well as the delivery of materials, as we understand the need and value this brings to our clients. Both speed-to-patient and speed-to-market are vital for our clients, and our approach to running PR&D (Prototype Research and Development), analytical development and solid form studies in parallel, typically takes 3-6 months out of an overall drug substance timeline and can remove up to 18 months for a fully integrated drug substance to drug product programme.

The Quotient Sciences approach enables clients to take projects through preclinical phase and beyond with minimum risk. We are uniquely placed in being able to bridge the design processes for drug substance, drug product and clinical development of new chemical entities all at one organization.

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