Examine Phase-Appropriate Regulatory, Technical and Quality Elements for Characterisation, Comparability, and Control Strategies
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Biological therapeutics and vaccine products require an array of analytical methods to characterise their biomolecular structure and biological functions. The CMC elements needed to support product safety and efficacy are defined in a diverse array of regional and global regulatory guidances. The molecular complexity of each biological product dictates the analytical technologies necessary for its characterisation, comparability, and control strategies. But all biological product modalities require similar types of CMC analytical studies and key analytical data sets during development.
This introduction to CMC analytics for biologics, cell & gene and biosimilars course will provide you with a comprehensive overview of the phase-appropriate analytical expectations for biological products of any type (novel or biosimilar protein therapeutics, well-characterised or classic vaccines, advanced cell or gene therapies). Once completed, you will understand which analytical studies are needed, why they are important, and where to find technical guidance for your specific product modality. You will learn the most common mistakes made in method lifecycle elements, reference standard management, stability programs and comparability studies, and how to avoid them, especially under highly accelerated CMC timelines.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.
This course provides a comprehensive overview of CGT. It is aimed at technical professionals who are either new to the industry or thinking about a career move into CGT. If you are a someone with experience in small molecules or biologics this course is will suit you.
These include:
Pre-course
Action Plan
Reinforcement Session
Introduction to CMC analytics for biologic, cell & gene, vaccine and biosimilar products
DD MMM 2023 | Session 1 |Â 120 mins | 13:00 PM UK
Current CMC regulatory requirements and hot-button issues for biological and cell & gene products
DD MMM 2023 | Session 2 |Â 120 mins | 3:15 PM UK
Phase-appropriate analytical method lifecycle expectations for biological and cell & gene products
DD MMM 2023 | Session 1 |Â 120 mins | 13:00 PM UK
Specifications, reference standards, and critical assay reagents
DD MMM 2023 | Session 2 | 120 mins | 13:00 PM UK
Phase-appropriate stability and comparability requirements for biological and cell & gene products
Nadine Ritter – CMC, Analytical Expert – Biologics & Advanced Therapies
Nadine M. Ritter, Ph.D., obtained her master’s and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years.
Dr. Ritter entered the biopharma industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer, and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for in vitro diagnostic product submissions, responded to FDA comments, contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of an R&D analytical lab.
Dr. Ritter then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements.
In 1999, she created the first public training class specifically focused on biological product stability programs, which later grew into an award-winning CMC analytical training course. She conducts in-depth training workshops on all aspects of CMC analytics for biologically-derived products, updating class materials and reference documents each month.
Since 2002, Dr. Ritter has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA).
In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. Through Global Biotech Experts, she can bring in affiliate support from elite consulting colleagues with extensive experience in process development and validation, manufacturing facility PAI and GMP inspections, and technical writing for R&D and GMP applications.
Throughout her career, Dr. Ritter has contributed to the success of over 120 international IND/IMPD and BLA/MAA filings and Post-Approval Change Protocols. She has engaged in numerous PAI readiness audits and due diligence inspections and has remediated analytical, regulatory and laboratory compliance problems around the world. She is on the CMC scientific advisory boards of several international biopharmaceutical companies.
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This product has multiple variants. The options may be chosen on the product page
