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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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.
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Info SheetDrug-Drug Interaction (DDI) StudiesAssessing how your drug interacts with other drugs in vivo is a critical step in the drug development process and is essential in ensuring safe and efficacious drug delivery. This assessment is known as a drug-drug interaction (DDI) study and is a regulatory requirement for submissions of investigational new drugs (INDs). Learn more about Quotient Sciences' offering for DDI studies.