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CMC Strategy Forum January 2020
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The Impact of Excipients and HCPs on the Formation of Particles in Biologics
Forum Co-chairs:
     
Taro Fujimori, AbbVie Bioresearch Center
      Ewa Marszal, CBER, FDA 
      Rachel Novak, CDER, FDA  
      Jason Starkey, Pfizer, Inc.   
Scientific Organizing Committee: 
      Kristopher Barnthouse, Janssen Pharmaceutical R&D, LLC 
      Fiona Cornel, Health Canada 
      Vincent Corvari, Eli Lilly and Company 
      Jennifer Sexton, Genentech, a Member of the Roche Group 
      Joey Studts, Boehringer Ingelheim Pharma GmbH & Co. KG


Excipients unquestionably play an essential role in the stabilization and formulation of biologics and vaccines.  However, evolving evidence has indicated that degradation of excipient components can occur during storage.  One outcome of excipient degradation is the possible formation of particles (visible and subvisible) in biologic formulations, which presents a concern from a product quality perspective.  Through recent advances in analytical technologies, our capability to detect and measure low level or trace impurities has strengthened our capacity to observe and better understand excipient degradation.  In particular, many recent research papers and presentations have focused on the presence of certain HCPs and their impact on particle formation through degradation of polysorbates.  With heightened awareness of these possibilities, companies are better prepared to address particle formation as part of the control strategy. 

In this session, we intend to discuss various case studies describing mechanisms and/or pathways for particle formation resulting from excipient degradation.  The analytical sciences used to interrogate and quantify particles, HCPs, and the chemical analysis of complex excipient components will be presented.   Finally, expectations from regulators will be discussed as it pertains to the development and control strategies for biotherapeutics.  

 

Leveraging Stability Studies to Support Product Licensure and Lifecycle Management  
Forum Co-chairs:
     Barry Cherney, Amgen Inc. 
     Chana Fuchs, CDER, FDA  
     Timothy Schofield, CMC Sciences, LLC  
     Dean Smith, Health Canada 
Scientific Organizing Committee: 
     Natalie Ciaccio, BioMarin Pharmaceutical Inc. 
     Darrin Cowley, AstraZeneca 
     Juliana Kretsinger, Eli Lilly and Company 
     Brian K. Nunnally, Seqirus, a CSL Company  
        

The stability of biologicals is a key aspect of product licensure and lifecycle management. ICH Q5C Stability Testing of Biotechnological/Biological Products outlines the specific requirements for these classes of products, with emphasis on conditions which can impact potency and purity throughout a product’s shelf life. ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process provides further guidance on real time/real temperature, accelerated and stress stability studies performed to support comparability after a process change.

While ICH Q5C provides guidance on the design and analysis of core stability studies under recommended storage conditions, interpretation of the results and the potential use of supportive stability data (pre-clinical and pre-pivotal) in establishing commercial expiry and temperature excursions is not described. The latter issue frequently results in primary stability studies impacting the filing timelines and patient accessibility.  Furthermore, ICH Q5E lacks any detail on the design and analysis of accelerated and stress stability studies to support changes to a manufacturing process and creates considerable uncertainty on the design and acceptably of the results and conclusions from the comparability studies performed.

This CMC Strategy Forum will examine some of these challenges from both a scientific and regulatory point of view and identification of best practices that are likely to meet regulatory expectations. Topics which will be covered are:

Design and analysis of stability studies supporting process changes throughout a product’s lifecycle;
Uses of supporting stability studies in addition to primary data in defining the product shelf life; and
Appropriate interpretation of stability data to ensure clinical performance is not affected. 

Presentations on these topics will be followed by panel discussion where all participants can further examine appropriate technical and regulatory pathways towards resolution.
     


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