Developing process understanding for continuous manufacturing of Lamivudine (Epivir®) Stable Form I

Ojo, Ebenezer and Hosni, Zied and Onyemelukwe, Iyke and Ramakers, Lennart and Houson, Ian and Florence, Alastair (2019) Developing process understanding for continuous manufacturing of Lamivudine (Epivir®) Stable Form I. In: 50th Annual Conference of the British Association of Crystal Growth, 2019-07-09 - 2019-07-11.

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    Abstract

    Why the considerations for Lamivudine? * Increasing numbers of HIV/AIDS infections on yearly basis (2.1 million new cases in 2015, UNAIDS) * Hepatitis B infections (257 million cases globally, WHO) * Currently FDA-approved antiretroviral therapy for the prevention and treatment of both viral infections (FDA). Key research considerations and interests To the best of our knowledge, no publication yet exists on continuous manufacturing of stable Lamivudine form 1. The key research question here is: * Translate current batch crystallisation into a continuous process? * Improve the downstream process-ability by modifying the particle properties? * Develop miniaturise platforms for accelerated process development?