Orphan Drug Development

Product description

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.

- Integrated capabilities and expertise- 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
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