Oncology
Accelerate the development of your oncology drug candidate
Supporting oncology drug development from candidate selection through to commercial manufacture and supply
Quotient Sciences understands the challenges associated with developing oncology drugs and has the expertise to successfully support biotech and pharmaceutical companies in accelerating development timelines from candidate selection through to commercial manufacture and supply.
Whitepaper
Accelerating the Development of Oncology Medicines
As a fully-integrated manufacturing organization, Quotient Sciences is positioned to address the challenges associated with developing small molecule oncology therapeutics, supporting biotech and pharmaceutical companies in accelerating drug development timelines from candidate selection through to commercial manufacture and supply. Learn more about our capabilities in our latest whitepaper.
Supporting you from pre-formulation through commercial manufacturing
Pre-formulation assessment & formulation development
With unparalleled biopharmaceutics experience, we factor in and anticipate clinical considerations as well as the in vitro performance of pharmaceutical formulations. Early laboratory prototyping is performed on bench scale equipment in order to de-risk process scale-up and development should the molecule achieve its early clinical endpoints.
Clinical development & accelerating to POC
There are compelling drivers for small batch sizes, such as conservation of API, and dose flexibility in order to meet individual subject needs and reduced stability needs. Our experts provide the full spectrum of manufacturing and supply paradigms, from traditional large batch manufacturing, through bright stock distribution and personalized manufacturing.
Formulation optimization and validation of product performance in humans
Using Quotient Sciences' Translational Pharmaceutics® platform, formulation flexibility in healthy volunteer trials can be used to develop "patient-ready" formulations for oncology molecules in less than half the time of the industry standard. The integration of real-time manufacturing and clinical testing cycles enables formulation decisions to be made based on emerging human data.
Process development, scale-up & clinical manufacturing for Phase II/III
Recognizing the need to move rapidly through clinical development, we have the capability to efficiently scale-up drug product manufacturing processes from Phase I to meet the demands of later clinical trial requirements and ensure a seamless transition to larger-scale manufacturing and drug product commercialization.
Commercial manufacturing & supply
We work with our customers to configure a robust manufacturing and supply chain to meet their needs. We can accelerate development programs through registration and process validation and our manufacturing facilities support batch sizes ranging from less than 1 kg to over 500 kg for solid oral dosage forms and up to 350 L for liquid formats.
Get started today
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences addresses the challenges associated with developing small molecule oncology therapeutics. We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform.
Connect with us today to learn how we can help support the development and manufacturing needs of your oncology drug program.
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Access our resources
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Scientific PostersESMO Immuno-Oncology Poster - Hubro Therapeutics QSC204718 (Vaccine Study)A Phase I Study of the Cancer-specific Vaccine FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response
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WhitepaperAccelerating the Development of Oncology MedicinesOncology drugs dominate today’s research focus with over >5500 molecules in development, representing over 35% of the total industry pipeline. 10 new oncology drugs were approved by FDA in 2019, of which half had an orphan indication and all had been granted priority review. Given the number of molecules in development, there is increasing pressure on development teams to identify successful drug candidates as quickly as possible, and accelerate patient access, particularly where no effective therapies are currently available.
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Scientific PostersAAPS 2019 Poster- Applications and Benefits of Healthy Volunteer Trials to Accelerate Oncology Drug DevelopmentPresented at AAPS 2019: Phase I drug development for oncology compounds is traditionally conducted directly in patient populations. Oncology molecules have historically been cytotoxic, meaning their safety and risk:benefit profile makes them unviable for dosing in healthy subjects. While this ensures reduced nonclinical requirements, rapid access to patient data and an earlier assessment of efficacious potential, it can also present challenges. For example, patients recruited in Phase I trials typically are at end of life care and will be taking multiple co-medications and have multiple co-morbidities (e.g. liver and kidney function may vary greatly among the recruited subjects). Practically, recruiting patients into Phase I studies can also be problematic, requiring multiple clinical sites and protracted recruitment times for what would traditionally be single site, quickly recruited healthy volunteer studies.
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Scientific PostersRapid Development and Clinical Assessment of New Rectal and Oral Formulations for Ulcerative Colitis Using Real-Time Adaptive GMP Manufacturing and SupplyTOP1288 is a non-systemic kinase inhibitor (NSKI) being developed as a treatment for patients with ulcerative colitis. As a novel, locally-acting candidate, TOP1288 has low systemic bioavailability and therefore a dual-pronged formulation strategy was adopted with rectal and oral formulations being developed.