Advancing Your Oligonucleotide Product Commercialization

Join us for an insightful webinar delving into the intricate world of oligonucleotide therapeutics. Throughout this session, we will examine essential facets of manufacturing, the critical role of USP standards in guaranteeing quality, and optimized workflows designed for thorough quality assessment.

From innovative methodologies to scalability considerations, we will explore how adherence to USP standards ensures the integrity of oligonucleotide therapeutics. Additionally, we will reveal strategies for unlocking efficient and comprehensive quality assessment workflows tailored specifically for oligonucleotide therapeutics.

By participating in this webinar, attendees will have the opportunity to engage with industry experts, exchange knowledge, and learn:

• Oligonucleotide manufacturing specifications
• High level CMC points
• Challenges in analytical test methods
• Quality considerations for oligonucleotide product analysis
• USP quality standards on DNA and RNA Phosphoramidites
• LC/Q-TOF acquisition considerations for optimum oligonucleotide performance
• Data acquisition and processing techniques

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: Dr. Marc Lemaitre (Oligonucleotide Therapeutics CMC/Strategy Consultant, ML Consult LLC)

Marc Lemaitre holds a degree in Organic Chemistry and a PhD in Biochemistry from the University of Liège, Belgium. Since 1985 Marc’s professional interests has been focused on Nucleic Acids therapeutic as well as their diagnostic applications. After post-doc research including 2 years at the Pasteur institute in the team of Nobel Prize Luc Montagnier, Marc held positions of increasing seniority in R&D, operations, business development, and general management within CMO's, Pharma and Biotech companies.

Based in the USA since 2006 he worked for Glen Research [Sterling, VA], then as CEO of Girindus America [Cincinnati, OH], a CMO with a focus on the cGMP manufacture of oligonucleotides for therapeutic applications. Since 2013 Marc is working as independent consultant specialized in CMC and working with start-up and Pharma companies developing therapeutic oligonucleotides and some peptides.

He is, among other membership, member of the Oligonucleotide Therapeutics Society (OTS – Board member from 2015 to 2021), member of the US Pharmacopeia Expert Committee BIO1 [peptides and oligonucleotides]. He authored more than 50 peer-reviewed papers mostly on nucleotides and oligonucleotides.

Presenter: Dr. Ashish Pargaonkar (Biopharma Workflow Commercialization Lead, Agilent Technologies)

Dr. Ashish Pargaonkar is a Lead for Biopharma Workflow Commercialization team for India and also Manager for Centre of Excellences at Bangalore. A Microbiologist by education with a Ph.D, he holds more than 20 years of experience for Biopharma market applications on Hi Resolution Mass Spectrometry.

He has a long record of successful demonstrations and customer engagements on workflows for CQA’s, Intact mass, peptide mapping, HCP and Glycans using Agilent state-of-the art solutions. He has authored ASMS posters on media components and therapeutic peptides. Dr. Ashish has been invited speaker at several conferences and workshops at Biosimilar Congress, ADC 2018, IIT (Mumbai, Delhi), ICT (Mumbai), PSI events.