TS1 - Core Principles and Best Practices for Biotech Analytical Test Methods Across the Product Lifecycle

TUESDAY, MARCH 5 AND WEDNESDAY, MARCH 6
DAY 1: 1:30PM – 6:00PM | DAY 2: 8:30AM – 5:30PM

TS1:
Core Principles and Best Practices for Biotech Analytical Test Methods Across the Product Lifecycle

Instructor: Nadine Ritter, Ph.D., President & Senior Analytical Advisor, Global Biotech Experts, LLC.

Introduction/Objective of the Course:

Current GMP requirements for test method validation are quite clear: Methods used for GMP product testing must be validated to demonstrate they can produce accurate and reliable results. But FDA and EU guidances are less clear about method ‘validation’ during product development. One the one hand, they indicate method validation is an evolving process, but on the other they state that method validation data should be available upon request at phase 2 and phase 3. These guidances also indicate that test methods only need to be qualified for Phase 1 (except safety methods, which do require validation prior to Phase 1). Methods used only for product or process characterization, comparability or similarity also need to be qualified to demonstrate they are scientifically sound. Some of these methods will start out in non-GMP labs then transfer to GMP labs; others will only ever be used in non-GMP labs. But during development, even data generated in non-GMP studies are critical for making process and product decisions, and are reported in product dossiers as supportive information. Although there is guidance on lab data integrity in GMP labs, there are no current guidance documents on data integrity in non-GMP labs.

The items to be covered in this course are:

Overview of ICH, FDA and EU guidance documents associated with method validation and data integrity for in-house and contract testing labs
Outline of types of test methods typically used with biotech/biosimilar products for characterization, comparability, similarity, release and stability testing
Illustration of typical method lifecycle events for test methods (optimization, qualification, validation, method changes, method transfer, method replacement)
Differences in study designs between qualification, validation, verification, tech transfer and bridging for biotech/biosimilar products
Overview of data integrity expectations for GMP analytical testing labs
Risks to data from non-GMP R&D labs at each phase of development and for key CMC analytical studies
Illustration of best-practices for lab quality and data integrity for non-GMP R&D labs

Target audience:

Analysts from R&D and QC, or non-GMP and GMP, laboratories
Process development scientists conducting product design, QbD, PPQ and CPV studies
QA reviewers of analytical data from key CMC process and product studies
RA managers of CMC analytical and stability dossier sections and updates
CMC project managers for pre and post approval activities
Personnel involved with in-house testing and/or contract testing facilities

About the Instructor:

Ritter_Nadine 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 years. 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 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. 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.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.