Allison Gillespie
VP Regulatory Affairs & Operations, all at Global Regulatory Affairs Solutions, Syneos Health, UK.
JournalEU MDR implementation – what is changing for the medical device industry?
This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. MDR (EU) 2017/745 came into force in May 2017 and became applicable in May 2020. After multiple amendments to the MDR, the ...
JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
JournalBiosimilars CMC development considerations from the sponsor perspective
Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.