This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
CMC Strategy Forum January 2020
Share |

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

This Forum will: 

     ~Discuss approaches and best practices on the assessment of visible particles;
     - Discuss testing and control strategies;
     - Discuss why there are increased numbers of visible particles detected with the use of "new" compendial" methods; and 
     ~Discuss overall control around excipient surfactants from raw material, manufacturing controls to final product release and stability testing. 

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.

 To visit the WCBP 2020 meeting homepage, click here

 Want more information? Check out the "More in this Section" dropdown box at the top of the page!
Or contact CASSS at 510-428-0740 or


To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

Membership Software Powered by YourMembership  ::  Legal