Short Courses* 

Tuesday, March 10 | 6:00 – 9:00 pm

Speaker Biographies 

SC2: Sub-Visible Particles, Aggregates and Impurities: Measurement, Characterization and Impact - Detailed Agenda 

Instructors:

Patricia W. Cash, Ph.D., Senior Director, Analytical Biotechnology, Biopharmaceutical Development, MedImmune, Inc.

Dean Ripple, Ph.D., Group Leader, Bioprocess Measurement Group, National Institute of Standards and Technology

Srivalli Telikepalli, Ph.D., Research Chemist, Molecular Measurement Division, National Institute for Standards and Technology 

Agenda outline:

Introduction to SVPs, Aggregates and Impurities

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

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

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

Recent Experiences and Case Studies Discussion with Q&A 

SC3: Glycobiology of Antibodies - Detailed Agenda  

Instructor:

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

Agenda outline:

• 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 12 | 6:00 – 9:00 pm

SC4: Assessing Biopharmaceutical Comparability via Biophysical Characterization - Detailed Agenda 

Instructor:

Steven A. Berkowitz, Ph.D., Consultant

In this short course, we will focus our attention on discussions concerning the integral role that biophysical characterization plays in supporting comparability studies in developing biopharmaceuticals. Much of the activities centered in this area are concerned with the task of building and utilizing a biopharmaceutical’s biophysical fingerprint. This fingerprint is a key element in assessing the higher-order structure (HOS) information on a biopharmaceutical, which is then employed as the master comparator for detecting differences in the biopharmaceutical during its development. Since no one biophysical tool can adequately provide this complete fingerprint, a battery of biophysical tools will be required.

Agenda outline:

• Setting the stage as to what the needs and goals are in conducting biophysical characterization
• Building the biophysical fingerprint
• Part I: Low resolution biophysical characterization tools
• Part II: Assessing biophysical properties
• Part III: The challenges of high-resolution biophysical characterization tools
• The H/DX-MS &NMR story
• Discussing the unique problems and challenges in biophysically characterizing biopharmaceuticals at high concentration

SC5: Comparability and Biosimilarity: - Detailed Agenda 
Principles and Case Studies

Instructors:

Christopher Holloway, Ph.D., Group Director, Regulatory Affairs & CSO, ERA Consulting Group

Marjorie Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies/OBP/OPS, CDER, FDA

The focus of this short course is on CMC issues around comparability and (bio)similarity, on the one hand covering expectations for an analytical comparability exercise accompanying process changes during development as well as post-marketing changes of a biologic and, on the other hand, addressing the analytical and functional tests used to establish (bio)similarity between a biosimilar product and the reference product. The course will offer both the US FDA and the EU perspectives and experiences on these subjects. The impact of the implementation of a design space and continual process verification on post-marketing comparability will also be discussed. Apart from the principles of comparability and (bio)similarity, practical advice on frequently asked questions, such as “how many batches?” will be discussed in detail, in the context of the attributes of the respective analytical methods, their variability, and the consistency of the datasets. Where possible, case studies will be presented, to highlight the potential pitfalls that have been encountered with comparability and (bio)similarity exercises. The particular problems arising from process changes during development of a biosimilar product will be discussed, as this adds the complication of a comparability exercise alongside the demonstration of (bio)similarity.

Topics will include:

• Principles and practice of a comparability exercise according to ICH Q5E
• Case studies in comparability accompanying process changes, during development and post-approval, what is required when?
• Comparability protocols (US) and change management protocols (EU)
• Comparability versus (bio)similarity exercises, definitions
• Demonstrating (bio)similarity between a biosimilar and reference product at various stages of development
• Experiences to date with biosimilar products, successes and failures
• The complication of process changes during clinical development of a biosimilar product

Dinner will be served during the short courses

*Separate Registration Required.