Enhance your orphan drug development
Accelerating orphan drug development from candidate selection to commercial manufacture and supply
With over 300 million people worldwide living with identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of great interest in the pharmaceutical industry.
Despite improvements in regulatory support and commercial rewards for developing orphan drugs, difficulties remain for drug developers in bringing these medicines to market quickly; including limited R&D budgets, alongside an ever-evolving regulatory framework, challenging product development and clinical recruitment.
Download a copy of our whitepaper to learn more.
Integrated capabilities and expertise
At Quotient Sciences we have supported over 50 development programs for rare disease in the past 5 years. Our extensive formulation know-how, clinical pharmacology expertise, coupled with our agile and flexible approach to clinical and commercial manufacturing, makes us the ideal partner.
From pre-formulation and formulation development through clinical development and scale up for commercial manufacturing we provide an end-to-end solution for the development of orphan drug products. Our extensive expertise and capabilities for orphan drug development includes:
- Pre-formulation and API characterisation.
- Formulation and process development.
- First-in-human clinical testing and acceleration into POC trials.
- Bespoke clinical manufacturing and supply (Phase I-III) of drug products into patient trials.
- Rapid scale-up and commercial manufacturing of low-volume products.
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences addresses the challenges associated with developing programs for rare diseases and orphan drug development . 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 orphan drug program.
Related content
Learn more about orphan drug development
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WhitepaperAccelerating the Developing of Orphan Drugs for Rare DiseasesWorldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.
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WebinarStreamlining the Delivery of 14C Human ADME Data: An ADME Q&A RoundtableOn December 6, 2022, join Quotient Sciences and The Netherlands Organization for Applied Scientific Research (TNO) for an interactive, hour-long live Q&A webinar focused on streamlining human ADME studies.
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Scientific PostersAAPS 2022 Poster: Kilo Scale Synthesis in Daisy Chained Flow ReactorsQuotient Sciences AAPS 2022 Poster, "Kilo Scale Synthesis in Daisy Chained Flow Reactors." (2R, 6R) hydroxynorketamine is a pharmaceutical undergoing trials as an antidepressant. An atom efficient synthesis route with norketamine as an intermediate is known. A low throughput flow synthesis route to norketamine had previously been developed, 2 however a manufacturing scale method was required. The objective of this study is to conduct the entire synthesis of norketamine from 2 chlorophenylcyclopentyl ketone in daisy chained reactors, built mainly from readily available parts at a throughput of > 1 kg/day.
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Scientific PostersAAPS 2022 Poster: Formulation and Taste Assessments in First in Human StudiesQuotient Sciences AAPS 2022 Poster, "Formulation and Taste Assessments in First in Human Studies"
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