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CMC Forum January 2019: Scientific Program
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To view the scientific program for the Continuous Manufacturing Forum, click here

To view the scientific program for the Commercial Specifications Forum, click here.



Impact of Government Shutdown on CMC and WCBP 2019

We expect you are aware of the partial shutdown of the US government, including non-essential activities of the FDA.  Unfortunately,  we have been informed that, due to the prolonged and uncertain nature of the situation, the FDA leadership regretfully made the decision to withdraw participation from the conferences. 

Anticipating that this could be a possibility, we had already begun working with the conference co-chairs to re-configure the program.  Updates, as they become available, will be reflected on the Scientific Program pages.


Continuous Manufacturing for Biologics 

Joslyn Brunelle, CDER, FDA
Andrew Chang, Novo Nordisk Inc.
Manon Dubé, Health Canada
Rick Lu, AstraZeneca 

Lindsay Arnold, MedImmune, A member of the AstraZeneca Group
Celia Cruz, CDER, FDA
Thomas Garcia, Pfizer, Inc.
Alexey Khrenov, CBER, FDA
Arne Staby, Novo Nordisk A/S
T.G. Venkateshawaran, Merck & Co., Inc.
Veena Warikoo, Roche Diagnostics GmbH
James Weidner, Amgen Inc.
Min Zhu, Boehringer Ingelheim

Continuous manufacturing has the potential to improve agility, flexibility, and robustness in manufacture of pharmaceuticals. ICH has recently decided to form an expert working group to generate a technical and scientific guideline on continuous manufacturing for global implementation. This emerging technology, however, has not been reflected in a wide adoption for manufacture of biologics, especially for the downstream manufacturing processes. This CMC Strategy Forum provides for a timely opportunity to discuss the opportunities, gaps/limitations and regulatory landscape across academics, technology innovators, biopharmaceutical companies and the regulators. The outcome of this CMC Strategy Forum will help establish expectations to facilitate implementation and improvement of continuous manufacturing for biologics.

Questions to be addressed:

What are the business opportunities for introducing continuous manufacturing for biologics?
What are current gaps and hurdles for implementing continuous manufacturing for biologics?
What levels of automation in biopharmaceuticals is needed for continuous manufacturing?
What novel analytical technologies are needed for continuous manufacturing?
Are there any different regulatory expectations between small molecule drugs and biologics for implementing continuous manufacturing?  

The Development of Patient-focused Commercial Specifications through Understanding of Clinical Relevance and Criticality of Quality Attributes

Maria Teresa Gutierrez-Lugo, CDER, FDA
Anthony Mire-Sluis, AstraZeneca
Jason Starkey, Pfizer, Inc.

Fiona Cornel, Health Canada
JR Dobbins, Eli Lilly and Company
William Egan, GSK Vaccines
Neha Frantz, Biogen
Taro Fujimori, AbbVie Bioresearch Center, Inc.
Kavita Mistry, Genentech, a Member of the Roche Group

This CMC Forum will include topics covering the definition, identification, control and management of patient focused attributes throughout the lifecycle of biological products including vaccines. The Forum will investigate how, along the product development lifecycle to approval, to differentiate what attributes are ‘clinically meaningful’ from those that might be applied for manufacturing capability and/or process consistency. It will explore what attributes have been identified as CQAs, those that have been shown not to have clinical relevance and how it was done, plus develop a lifecycle approach to clinically meaningful specification development. Approaches to establishing CQAs through the use of modelling (e.g. molecular, immunogenicity), prior knowledge, nonclinical and clinical experience will be discussed. CQAs that require specifications - for example, bioburden, sterility (for aseptic products), content/potency etc. versus more product- specific attributes that have been shown to be clinically relevant CQAs will be explored. The forum will not only describe clinically meaningful attributes, but also explore how to set associated acceptance criteria or limits.

Some questions to be answered are as follows:

  Are ‘Clinical Relevance’ and ‘Clinical Exposure’ fundamentally different?
  Based on existing knowledge, are there are some product attributes (modality specific) that can be generally accepted as ‘not clinically relevant’? (e.g., C-terminal lysines for mAbs,) and what level of knowledge is needed to justify?
  Can different approaches be used for specification setting based upon known clinical relevance, or lack thereof? 
  What are some considerations related to clinical experience and determining acceptance criteria: multiple batches, number of studies, number of patients, is exposure more than pivotal clinical studies, can PK/PD studies be used?  
  How to leverage prior knowledge in establishing CQAs and the associated control strategy 

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