Midwest Regional Forum Reference Standards, Critical Reagents and Assay Controls

Midwest Regional Forum

Reference Standards, Critical Reagents and Assay Controls – How to Manage and Case Studies

Wednesday, November 6, 2019

Eli Lilly and Company Indianapolis, IN

Meeting Co-chairs: Qin Sheng, Eli Lilly and Company Amy St. Charles, Pfizer, Inc.

Acknowledgements

Special thanks to the program committee who developed this program.

Program Committee: Sergey Arzhantsev, CDER, FDA Leslie Bloom, Pfizer, Inc. Michael Boyne, COUR Pharmaceuticals Development Company Holly Cargill, Pfizer, Inc. James Carroll, Pfizer, Inc. Sarah Demmon, Eli Lilly and Company J.R. Dobbins, Eli Lilly and Company Will Hatcher, Catalent Biologics Julie Heflin, AbbVie Inc. Michelle Lytle, Eli Lilly and Company Khalid Mahmood, Eli Lilly and Company Lisa McDermott, MilliporeSigma Ed Moore, University of Illinois Ned Mozier, Pfizer, Inc. Lesley Redfern, AbbVie Inc. Robert Seevers, Pearl Pathways Qin (Chin) Sheng, Eli Lilly and Company Amy St. Charles, Pfizer, Inc. Jason Starkey, Pfizer, Inc.

CASSS Staff: Karen A. Bertani, CMP, Director, Global Community and Knowledge Sharing Rose Bueno, Member Relations Coordinator Alissa Doyle, Program Planning Coordinator Stephanie L. Flores, CAE, Executive Director Julie Harris, CMP, Program Manager Isolde Honoré, Exhibitor Relations and Technology Coordinator Renee Olson, Senior Program and Marketing Manager Anne Ornelas, Senior Operations Manager Catherine Stewart, Director of Finance

The program committee gratefully acknowledges the following program partners and exhibitors for their generous support of the CASSS Midwest Regional Forum:

Strategic Gold Program Partners

Eli Lilly and Company

Pfizer, Inc.

Scientific Program Summary

Wednesday, November 6, 2019

8:00 - 9:00 Registration & Coffee/Continental Breakfast

9:00 - 9:10 CASSS Introduction JR Dobbins, Eli Lilly and Company, Indianapolis, IN, USA

9:10 - 9:20 MWRF Meeting Introduction Qin Sheng, Eli Lilly and Company, Indianapolis, IN, USA

Morning Session Session Chair: Qin Sheng, Eli Lilly and Company, Indianapolis, IN, USA

9:20 - 10:05 Biotech Analytical Standards, Controls and Reagents: The Good, The Bad and The Ugly (Not Necessarily in That Order) Nadine Ritter, Global Biotech Experts, LLC, Germantown, MD, USA

10:05 - 10:15 Break

10:15 - 11:00 Setting the Bar: An Industry Perspective on Reference Standard Characterization and Specifications Sarah Kiehna, AbbVie Inc., Chicago, IL, USA

11:00 - 11:40 Reference Standard Life Cycle Management – An Industry Perspective Lisa Spurlock Brouwer, Eli Lilly and Company, Indianapolis, IN, USA

11:40 - 12:10 Stability Studies at MilliporeSigma: Taking a Contract Manufacturing Organization Approach Matt Lippold, MilliporeSigma, St. Louis, MO, USA

12:10 - 13:10 Lunch

Afternoon Session Session Chair: Amy St. Charles, Pfizer, Inc., St. Louis, MO, USA

13:10 - 13:40 Apples to Apples Equivalency? A Bioassay Reference Material Bridging Approach for Method Lifecycle Management Raleigh Tenney, Pfizer Inc., St. Louis, MO, USA

13:40 - 14:10 Critical Reagent Manufacture and Impact on Bioassay Jodi Pegg, Pfizer Inc., St. Louis, MO, USA

14:10 - 14:30 PCA Technology for Critical Reagent Characterization and Management Xing Wang, Array Bridge Inc., St. Louis, MO, USA

14:30 - 14:40 Break

14:40 - 15:15 PANEL DISCUSSION – Questions and Answers Nadine Ritter, Global Biotech Experts, LLC, Germantown, MD, USA Sarah Kiehna, AbbVie Inc., Chicago, IL, USA Lisa Spurlock-Brouwer, Eli Lilly and Company, Indianapolis, IN, USA Matt Lippold, Millipore Sigma, St. Louis, MO, USA Raleigh Tenney, Pfizer Inc., St. Louis, MO, USA Jodi Pegg, Pfizer Inc., St. Louis, MO, USA Xing Wang, Array Bridge Inc., St. Louis, MO, USA

15:15 - 15:30 Closing Remarks Amy St. Charles, Pfizer, Inc., St. Louis, MO, USA 15:30 Adjourn

Program Abstract

Reference Standards, Critical Reagents and Assay Controls – How to Manage and Case Studies

Reference standards, critical reagents and assay controls play critical roles in calibrating and confirming the suitability of analytical methods used to assess quality attributes of biologics during characterization, comparability, lot release, and confirmation of stability. In this session, we will explore strategies used to manufacture, characterize, control, and maintain reference standards, critical reagents and assay controls throughout a product’s life cycle.

The learning objectives for this forum are: 1. How to characterize reference standards and establish phase appropriate specifications 2. Potency assignment and bio-equivalence between batches 3. Stability monitoring and overall life-cycle management strategies 4. Novel technology in characterization of critical reagents (tentative bonus topic)

NOTES:

Biotech Analytical Standards, Controls and Reagents: The Good, The Bad and The Ugly (Not Necessarily in That Order)

Nadine Ritter, Global Biotech Experts, LLC, Germantown, MD, USA

Analysis of pharmaceutical products required test method procedures that yield accurate and reliable results. Because of their molecular complexities and mechanisms of action, biologically- derived products utilize a plethora of physical and functional technologies for their characterization and control. In some of them, product-specific reference materials are required to generate the reported test result. In others, reference materials and controls are used to confirm test results are valid. This presentation will describe different categories of biotech product standards, assay controls and critical analytical reagents and materials. It will highlight current issues in establishing reference standards, and emerging issues with standards for biosimilar and cell/gene therapy products. Also, since the accuracy and reliability of biotech methods can be substantially affected by the quality and consistency of components used in the procedure, this presentation will illustrate personal (painful) experiences in identifying and controlling critical analytical reagents for a wide array of test method technologies.

Notes:

Setting the Bar: An Industry Perspective on Reference Standard Characterization and Specifications

Sarah Kiehna, AbbVie, North Chicago, IL, USA

A well-defined reference standard strategy is critical for ensuring quality during drug development. Different types of standards can be employed for different purposes during development, with a fit-for-purpose characterization approach. In the case of product reference standards, a progressive approach using phase-appropriate specifications along with primary and secondary standards can protect against a drift in product quality. This talk will provide an overview of the different standards with recommendations for characterization and specifications throughout development.

Reference Standard Life Cycle Management – An Industry Perspective

Lisa Spurlock Brouwer, Eli Lilly and Company, Indianapolis, IN, USA

Reference standards are the basis for assuring the quality of medicines for patients during cGMP testing and release activities. Reference standards are developed as part of the analytical control strategy for each drug substance and product. As the basis for patient dose and product identity, it is critical to ensure that reference standard materials and information are appropriate for the current stage of drug development. This talk will present an industry perspective on when to establish different types of reference standards during the drug development process, what information is needed to establish a reference standard and what documentation should accompany the material to make it usable in a lab setting. Details will also be provided on demonstrating that the reference standard material continues to be suitable for use.

Notes:

Stability Studies at MilliporeSigma: Taking a Contract Manufacturing Organization Approach

Matt Lippold, MilliporeSigma, St. Louis, MO, USA

Stability studies play a critical role in evaluating and confirming the shelf life and quality of biologic products. This presentation will demonstrate stability program design strategies for biologics in contract manufacturing.

Key objectives for this presentation are:  Stability program design  Individual stability study design  Lessons learned

PCA Technology for Critical Reagent Characterization and Management

Xing Wang, Array Bridge Inc., St. Louis, MO, USA

Critical Reagents play important role in drug discovery and development, among the critical reagents, a significant portion are antibodies. Protein Conformational Array (PCA) technology is an antibody-based analysis that can provide fingerprint-like information on the target proteins. It has been shown that PCA can detect conformational changes of antibodies from human, mouse and rabbit origin with high sensitivity, covering both polyclonal and monoclonal antibodies. This presentation will provide studies on using the PCA technology to analyze conformational changes of different species of antibodies under different storage conditions and situations mimic the most often encountered conditions in a drug development setting, demonstrating the value of PCA technology in the monitoring and characterization of critical reagents.

Notes: