Short Courses* 

Tuesday, March 15, 5:45 – 8:45pm

SC1: SVPs, Aggregates and Impurities: Measurement, Characterization and Impact

Instructors:
Dean Ripple, Ph.D., Supervisory Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Srivalli Telikepalli, Ph.D., Research Chemist, Biomolecular Measurement, National Institute of Standards and Technology

Maryam Mazaheri, M.S., PMP, CMC Project Manager, Pipeline Management, Medimmune

Instructor Bios

Course agenda:

1. Introduction to SVPs, Aggregates and Impurities

• Current regulatory expectations
• Mechanisms behind formation of soluble aggregates and SVPs
• Potential biological impacts

2. Overview of Aggregates

• Causes of aggregation
• Characterization
• Current concerns in the context of immunogenicity with examples
• Elimination of aggregates through protein refolding and high pressure dissociation and other methods

3. Technologies and Tools for Identification and Characterization

• Aggregates (Size exclusion SEC, AUC, FFF, etc.)
• Sub-visible (Microflow imaging, light obscuration, etc.)
• Comparisons between technologies regarding limits of detection
• Open discussion on which approaches can be regarded as FDA compliant

4. Recent Experiences and Case Studies

5. Discussion with Q&A

Tuesday, March 15, 5:45 – 8:45pm

SC2: Glycobiology of Antibodies

Instructor:
T. Shantha Raju, Ph.D., Scientific Director, Biologics Research, Janssen Research & Development, LLC

Instructor Bios

Course agenda:

• Introduction to Protein Glycosylation
• Fc Glycan Heterogeneity
• Methods to Analyze Fc Glycans
• Glycoengineering Methods
• Role of Fc Glycans on Antibody Effector Functions
• Impact of Fc Glycans on Antibody Stability
• Discussion with Q&A

Thursday March 17, 6:00 – 9:00pm

SC3: New Analytical Approaches & Strategies for Comparability and Biosimilarity

Instructor:
Hans-Martin Mueller, Ph.D., Director, BioProcess Development, MSD Merck

David Wylie, Ph.D., Principal Scientist, Sterile Process and Analytical Development, Merck

Instructor Bios

Providing convincing comparability studies is a key success factor for the filing of novel biologics. This is even more important for the steadily growing new field of biosimilars and biobetters. In this case, comparability studies are combined with demonstrating similarity. For a proper planning of novel or biosimilar development programs, it is important to understand the development costs, timelines and the authoring of CMC regulatory sections. The analytical characterization of comparability and similarity studies will form the cornerstone for each successful marketing authorization application of these products. This short course will be about analytical development and its challenges, technical hurdles, BLA authoring, timelines and costs. Participants will be introduced to state-of-the art analytical comparability and similarity strategies, leading to a smooth and efficient IND/BLA application and approval.

Course Outline:

• Cost and Resource Management
• Strategic Use of the Analytical Database
• Optimal Application of Modern Analytical Tools (e.g., Forced Degradation)
• Preparation of Strong and Convincing Files