Advance Your Peptide Product Commercialization: CMC and Regulatory Considerations
Join us for thought provoking webinar series on the entire value chain of therapeutic peptides.
Register now and get an opportunity to learn about:
- Peptide manufacturing specifications
- Raw materials and intermediates
- USP general chapters and regulatory considerations
- Chromatographic strategies for optimizing peptide analysis and purification with reversed phase chromatography and suitable stationary phases
- End-to-end analytical to preparative workflow for synthetic peptides
Untold Control Strategies in Complex Peptide Manufacturing
- Dr. Vasanthakumar G. Ramu
Regulatory Considerations for Peptides Therapeutics
- Dr. Manoj Kumar Metta
Analysis and Purification of Synthetic Peptides
- Ms. Paramjeet Khandpur
Presenter: Dr. Vasanthakumar G. Ramu (Vice President – Head R&D, Peptides and Complex API’s, Alembic Pharmaceutical Ltd.)
Dr. Vasanthakumar Ramu, is one of the pragmatic scientists in the pharma industry working around complex API’s. He studied chemical biology from Bangalore University and Indian Institute of Science. In early 2007, hemoved to Max-Planck Institute of Molecular Physiology to work on peptide decorated supramolecular architectures as modulators to study cell protein interactions. Continued further studies as research scientist in Ruhr Universität Bochum, Germany, with the objective to work on backbone modified peptides of HIV protease inhibitors. In 2011 spring, moved to Spain, where he was working as Marie Curie Experienced Researcher to develop Kyotorphin derived peptides, antimicrobial peptides, and other small molecules for neurodegeneration. Returned to India in 2012 and led the startup company called Omgene Life Sciences Pvt. Ltd. Before joining Alembic, was heading peptide process development groups in Biocon Ltd., and Aurobindo Pharma Ltd., Transferred the technologies, successfully validated and filed various DMF’s and involved in commercialization of API’s.
His work was centered on developing diverse peptides and complex therapeutic API’s to treat T2D and various other health ailments. Published more than 30 peer reviewed scientific articles and 50+ patent applications filed/granted in various IP jurisdictions. Dr. Vasanthakumar’s efforts have been recognized through Marie Curie and Max Planck Institute fellowships. He is fellow of Chemical Research Society of India (CRSI) and Nuclear Magnetic Resonance Society of India (NMRS) and recently, he has been invited as Fellow of Royal Society of Chemistry, London in leadership category in recognition of his contributions in chemical sciences. Presently, heading R&D, and leading end to end development and technology transfer activities for various peptides and complex generic API’s.
Presenter: Dr. Manoj Kumar Metta (Team Lead, Senior Scientist II Global Biologics, United States Pharmacopeia (USP))
Dr. Manoj Metta is a renowned Biological Scientist with 21 years of experience in Biologics Quality assessment, and Regulatory sciences. He has rich hands-on experience in commercial development of protein, and peptide biopharmaceutical products with emphasis on developing analytical control strategies, physicochemical and functional characterization, analytical method development/validations and CMC review to support product licensure in global markets.
Dr. Manoj brings a wealth of experience and expertise to his role at the US Pharmacopeia (USP), where he has served for over 12 years in various scientific capacities. His contributions span across multiple areas, including the development of Monographs, Reference standards and General chapters in therapeutic proteins, monoclonal antibodies, synthetic peptides, and oligonucleotides. Dr. Manoj is a frequent speaker at national and international biopharmaceutical and regulatory scientific events.
Academically, he received Ph.D. degree in Biotechnology from Gandhi Institute of Technology and Management, on “Development of novel mammalian expression systems by using polyomaviral elements in CHO cell line” for monoclonal antibody production”.
Presenter: Ms. Paramjeet Khandpur (Biopharma Workflow Commercialization Lead. Agilent Techologies)
Paramjeet Khandpur, M.Tech., holds a bachelor’s degree in chemical engineering from VTU University and a Master's in Bioprocess Technology from the Institute of Chemical Technology, Mumbai. Paramjeet is currently the Biopharma Workflow Commercialization Lead at Agilent. In this role, she leverages her expertise to deliver comprehensive workflow solutions and offer support to customers, catering to their analytical requirements across the Biopharma value chain.
Previously, she worked as an Application Engineer at Agilent's Centre of Excellence Lab in Bangalore, specializing in various liquid chromatography platforms. She also collaborated with users in the Pharma and Biopharma industry for method development, troubleshooting, and method transfer.
