The Analytical Journey Of A Biologic Drug: From Discovery Through Commercialization
In this webinar, SGS experts share their extensive knowledge of the testing required at each stage of biologic drug development, offering insights into overcoming common challenges and ensuring a seamless journey from pre-clinical development to commercial release.
The discussion explores critical steps in the pre-clinical early characterization phase, Phase 1 and 2 testing for various biologic modalities — including characterization, bioassays, and other complex assays — and the specialized testing and regulatory requirements necessary for commercial release.
By watching the webinar, you'll gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and strategies for addressing challenges associated with these approaches. Additionally, the webinar covers compliance strategies, best practices for meeting regulatory requirements, and essential considerations for documentation and reporting.
Don't miss this opportunity to deepen your understanding of biologic drug development and navigate the path to regulatory approval with confidence.
Featured Speakers:
Mahdi Roohnikan, Ph.D., PMP, Technical Client Manager, Biologics, SGS
Dr. Roohnikan serves as the Technical Client Manager for the Biologics division at SGS’s Mississauga, CA site, bringing over five years of biotech experience to support clients in defining and initiating their critical CMC testing needs. He also plays a key role in tech transfer projects, helping clients navigate regulatory filings for new and biosimilar modalities. His expertise spans gene therapy delivery, biologics characterization, protein purification, proteomics, and biodata analysis. Dr. Roohnikan holds a Master’s degree in Polymer Engineering from Amirkabir University and a Ph.D. in Chemical Engineering from McGill University.
Riya Binil, Ph.D., Scientific Manager, Biologics, SGS
Riya Binil is the Scientific Manager for Cell Biology at SGS’s Mississauga, CA site, where she leads a team focused on developing bioassays for biopharmaceutical products. With over seven years of industry experience, she specializes in cell-based assays for biosimilars, biologics, and cell and gene therapies. Binil collaborates closely with clients to address critical CMC testing needs, providing expert support in new method development, phase-appropriate validation, and quality control testing to ensure smooth regulatory submissions throughout drug development. Before transitioning to industry, she spent 12 years in academic research. She holds a Ph.D. in Cell Biology from the National Centre for Biological Sciences, India, and completed her postdoctoral research at the Ottawa Hospital Research Institute, Canada.