Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered, and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.

THURSDAY, JANUARY 23 - FRIDAY, JANUARY 24

TS7C: Introduction to Analytical Characterization and Method Validation for Protein Therapeutic Drugs

Aqua 303

DAY 1: THURSDAY

8:10 am - 5:15 pm Seminar Sessions

12:30 - 1:10 pm Lunch Provided
Exhibit Hall Refreshment Breaks also provided.

DAY 2: FRIDAY

9:00 am - 12:30 pm Seminar Sessions

Instructor:

Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.

This training seminar will review analytical method development and validation in the context of IND regulatory filing of therapeutic proteins, including monoclonal antibodies and recombinant proteins. The curriculum will provide a broad overview of biologics analytical and characterization methods and is beneficial to individuals involved in biologics drug development, analytical development, quality control, quality assurance, regulatory affairs, project management, process development, formulation development or related functional areas. Attendees will learn the practical aspects of commonly used analytical panel not only for DS/DP release and stability but also for monitoring manufacturing process and facilitating formulation development: product purity and impurity analysis, product strength and potency assay, process-related impurities such as identification and quantitation of host cell proteins. The characterization panel specifically emphasizes structure elucidation by mass spectroscopy, post-translational modification, biophysical characterization of higher order structure (HOS), and protein aggregates. New real-world case studies and common pitfalls will be presented during the presentation.

What You Will Learn:

• Protein as therapeutics: big molecule structure, PTM and instability (degradations)
• Updated regulatory guidance for IND filing (CTD)
• Role of analytical in biologics manufacturing process
• Systematic approach to method development (QbD/DoE), method writing, qualification report, and method transfer
• Product purity methods for IND: capillary electrophoresis (CE-SDS NR/R, cIEF) and chromatography (IEX, RP, SEC-UPLC)
• Bioactivity method for IND (enzymatic activity, binding ELISA and potency assay)
• Role of forced degradation in DS/DP stability program and formulation development
• Compendial methods (clarity, color, visible particles, osmolality, pH, OD280) and the criticality of matrix verification of process impurities (HCP, DNA, leachable ligand, bioburden, endotoxin and sterility) for in-process control and DS/DP release assay
• Structure elucidation by mass spectroscopy (peptide mapping, disulfide mapping, intact MW, reduced and deglycosylated “intact” MW), sequencing, AAA, glycan profile, sialic acid content, and biophysical characterizations (CD, fluorescence, DSC) for RS characterization and comparability study
• Protein aggregates and subvisible particles (SEC-MALS, DLS, SV, HIAC, MFI) to address immunogenicity concern (monitoring and control)
• Role of analytical and characterization in IND regulatory filing

Benefits of Attending this Seminar:

The training course is primarily an introduction to protein analytical procedures. However, the presentation includes in-depth discussion. Therefore, both analytical newcomers and experts in academia and industry will benefit from this training course. From this training seminar, attendees will

• Learn all the analytical procedure and characterization pertinent to protein therapeutics for regulatory filing
• Learn the best practice of developing analytical procedures and validate protein analytical methods
• Understand critical quality attributes (CQAs) of protein therapeutics and implement analytical control strategy (ACS)
• Understand how to design comparability study during protein drug development lifecycle

Instructor:

Kevin Zen, PhD, Executive Director, Analytical Characterization, Formulation Development and Biologics Manufacturing, AnaptysBio Inc.

Kevin has over 25 years of experience in biologics drug development. In his current role, Dr. Zen is responsible for overseeing analytical development, method validation, extended characterization, bioassay, comparability, formulation, manufacture and stability of vial and PFS for early clinical and commercialization of various biologics drug products. Prior to joining AnaptysBio, he held various positions in biologics CMC disciplines at Allergan, AstraZeneca, BD, and Catalent. His experience includes preparing and reviewing multiple INDs submitted to CBER or CDER.

WHAT IS A TRAINING SEMINAR?

Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.