In this advanced course, Dr. Nadine Ritter will take a deep dive into the design and execution of the major analytical CMC studies applicable to different types of biological products, with special notes on biosimilars. Best practices in the validation of methods for relative purity, relative potency, and product stability will be presented. Key details in designing phase-appropriate analytical comparability studies will be discussed, with comparison to unique issues for analytical similarity studies. Strategies will be presented to overcome typical technical challenges in managing reference standard and critical assay reagents. Finally, emerging analytical expectations for HCPs, SVPs, and E&L data will be discussed.
What will you learn?
Learn best practices to address the most difficult validation parameters in critical analytical methods for relative purity, relative potency, and specific impurities and degradants with biological products.
Characterization and comparability
Discuss characterization and comparability studies for a wide variety of biologics including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, plasma products, and complex products (e.g. antibody drug conjugates); review unique challenges in analytical biosimilarity studies
Explore different types and uses of biotechnology reference standards and understand the nature of critical assay reagents. Discuss important details on lifecycle management of product reference standards and critical assay reagents
HCPs, SVPs, and E&Ls
Understand the background of regulatory concerns for HCPs, SVPs, and E&Ls in biological products, examine the analytical challenges and learn the current and emerging best practices for analytical characterization, comparability, and control of each of these types of process and product impurities.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
During these sessions students will learn through:
- Direct interaction with the trainer during live sessions
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact email@example.com.
Who is this course for?
This course would be useful for:
- QC release and stability analysts
- Stability program managers
- Product scientists and test method technical experts (R&D and QC)
- Process analytical chemists and process development scientists
- Quality assurance specialists
- GMP compliance auditors
- Regulatory affairs CMC authors or reviewers
- Analytical and stability laboratory managers (R&D through GMP)
- Project managers with CMC responsibilities
- Business managers with CMC responsibilities
- Key staff from biotech academic incubators and small start-ups
- Contract testing labs
The analytical side of CMC with course leader, Nadine Ritter
Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others
Meet the Course Leader
Dr. Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.
She 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.
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.