CURRENT AND EMERGING GLOBAL REGULATORY EXPECTATIONS FOR ANALYTICAL ELEMENTS OF BIOTECHNOLOGY/BIOSIMILAR PRODUCTS
August 18-19, 2014
Day 1: 1:00 – 5:15 | Day 2: 8:30 – 5:00
Instructor: Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC
This 1.5 day class will present the driving concepts that distinguish the regulatory approach to the production and testing of biologically-derived from chemical, small molecule pharmaceutical products. It provides a comprehensive overview of how analytical elements come together in global regulatory dossiers, which can (should!) be used to drive the nature and timing of key CMC studies. It also provides an overview of how regulatory dossier CMC sections in marketing authorizations (BLA/MAA) are linked to analytical expectations in regulatory pre-approval inspections. All attendees will be given a searchable USB drive containing over 200 current and draft global regulatory and quality guidance documents associated with the development and commercialization of biotech and biosimilar products.
- Why are regulations different for biopharmaceutical products vs. traditional chemical products?
- What are the multiple types of world-wide regulations that detail CMC analytical study requirements for biotechnology/biosimilar products?
- What are the 10 (or 11 if biosimilar) non-negotiable CMC characterization, comparability, release specification and stability data packages required for a biotechnology-based product?
- How can these required CMC analytical and stability studies be staged most efficiently during the product development lifecycle?
- Which of these elements have the most critical project planning considerations based on their time and material requirements for biotechnology/biosimilar products, and why?
- How do regulators and inspectors categorize analytical test methods?
- Why do biotech products require orthogonal methods for physiochemical characteristics as well as functional potency assays?
- What are the commonly used and currently expected analytical methods for various types of biotechnology products (eg Mabs, vaccines, GT vectors, ADCs, etc…)?
- What is the difference between methods used for characterization and comparability studies vs. release and stability testing?
- Which analytical test methods have to be validated, and by when?
- What is the difference between method validation and method ‘qualification’?
- What is required to qualify vs. validate methods that are claimed to be stability-indicating?
- What are the current expectations for generating and maintaining method lifecycle document packages?
- What are the current and emerging expectations for biotech/biosimilar product reference standards?
- What are the requirements for biotech product stability studies during development and post approval?
- Why can’t shelf life dates be extrapolated from accelerated stability data for biotech/biosimilar products?
- What are the current analytical challenges for global development of biosimilar products?
- What are some of the current CMC ‘hot buttons’ for biotechnology analytical and stability studies that may cause regulatory review problems due to deficiencies in product dossiers?
Nadine Ritter obtained her master 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 yrs. She entered the biopharm 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 diagnostic product submissions, responded to FDA comments, and contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of the R&D analytical lab.
She 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 course specifically focused on biotechnology stability programs, which later grew into an award-winning CMC analytical training course.
Since 2002, she has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently at 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. In 2003, she was one of six industry and two FDA founders of the CaSSS CMC Strategy Forum, which has led to the publication of major industry/regulatory white papers on CMC topics, and is now being held annually in North America, Europe, Asia and Latin America.