Brenda Star Clemente
Director, Drug Product Process Development Arcturus Therapeutics
I am a seasoned leader in drug development with over 15 years of experience specializing in process development, scale-up, and technology transfer for complex biologics and RNA-based therapeutics. As Director and Head of Formulation and Drug Product Process Development, I drive the design and optimization of robust manufacturing processes, oversee process characterization studies, and ensures successful internal and external tech transfer across development stages.
My work spans a diverse portfolio of programs—including COVID-19, Influenza, Cystic Fibrosis, and OTC products—where I lead cross-functional efforts to advance products from preclinical through commercial readiness. I also play a key role in regulatory strategy, contributing to the compilation of CMC sections for global submissions.
I bring a deep technical expertise and strategic insight to the evolving landscape of mRNA-LNP therapeutics, with a focus on innovation, scalability, and regulatory alignment.
Seminars
- From Bench to Bedside: Optimizing LNP drug products through clinical phases to achieve scalable, regulatory compliant drug products
- Identifying differences in formulation priorities as the LNP program progresses towards later clinical development and commercialization
- Strategies for managing product comparability during process and formulation changes throughout development
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