Orphan Drug Development
How can I enhance my orphan drug development?
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Accelerating orphan drug development from candidate selection to commercial manufacture and supply
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.
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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WebinarUpcoming Webinar: Strategies for Achieving Regulatory Milestones FasterSave your spot for our next webinar featuring a customer case study from Ensysce Biosciences on April 19, 2023. Dr. Vanessa Zann, Senior Drug Development Consultant, will be joined by Lynn Kirkpatrick, CEO of Ensysce Biosciences for this special presentation.
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WebinarUpcoming Webinar: Quotient Sciences and Charles River Collaboration WebinarJoin experts from Quotient Sciences & Charles River for a webinar taking place on 18 May, "Integrated Strategies for Accelerating from Discovery to IND and Beyond: Charles River & Quotient Sciences Collaboration."
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WebinarBioanalytical Strategies for Insulin Analogues & Other Large Peptides Using LC-MSLearn how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues from Michael Blackburn, Head of Bioanalytical Method Development and Labs.