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CE Pharm 2016: Roundtable Discussion Notes
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Table 1: CE-SDS: Briding Between Different Kits. Reduced vs. Non-reduced - When to Focus on One?
Facilitator: Sarah Kennett, CDER, FDA 
Scribe: David Michels, Genentech, a Member of the Roche Group

To view notes from this discussion, click here 

 


 

Table 2: CE-SDS: Peak Identification
Facilitator: Christian Neusüß, Aalen University 
Scribe 
Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG

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Table 3: What are Opportunities and Challenges for Further Implementation of CE-MS in Development of Biologics? 
Facilitator
: Michael Knierman, Eli Lilly and Company
Scribe: Nathan Lacher, Pfizer, Inc.

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Table 4: Chip Based Separations vs Classical CE Separations
Facilitator: Friederike Winkhaus, Roche Diagnostics GmbH
Scribe: 
SungAe Suhr Park, Amgen Inc.

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Table 5: Glycan Analysis by HILIC-LC or CE. Are you Doing One or Both?
Facilitator: Sherry Guo, Genentech, a Member of the Roche Group
Scribe: 
Mark Lies, SCIEX

 To view notes from this discussion, click here

 


 

Table 6: CE's Role for Challenging Analytical Problems: New Therapeutic Protein Formats like Fusion Proteins, ADCs, Subvisible Particles, etc.
Facilitator: Lars Geurink, Janssen Infectious Diseases and Vaccines 
Scribe: Cari Sänger - van de Griend, Kantisto BV 

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Table 7: With Minimal Manufacturing Experience, What are Some Strategies for Setting Quantitative Specifications for Charge Variants and Size Variants?
Facilitator: Richard Rustandi, Merck & Co., Inc.
Scribe: Hermann Wätzig, TU Braunschweig 

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Table 8: Affinity Capillary Electrophoresis
Facilitator: 
Kathir Muthusamy, Regeneron Pharmaceuticals, Inc.
Scribe: Mona Mozafari, TU Braunschweig

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Table 9: What are the Common Strategies for Introducing New Instruments (i.e. Lab Chip, Maurice etc.) into the a GMP Testing Environment?
Facilitator: Xin Jiang, ProteinSimple 
Scribe: Zoran Sosic, Biogen

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Table 10: Do people Rely on Release Methods for Late Phase Process Characterization or Have High Throughput Workflows in Place to Support Such Activities?  How Similar do the Product Quality have to be Between the Release and the High Throughput Method?
Facilitator: Nomalie Jaya, Seattle Genetics, Inc.
Scribe: Mei Han, Amgen Inc. 

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Table 11: QbD and DoE in CE: Nice-to-have or Need-to-have?
Facilitator: Peter Bryngelson, Biogen
Scribe: Joel Welch, CDER, FDA 

To view notes from this discussion, click here.

 


 

Table 12: Adsorption and Capillary Conditioning: Bare fs vs. Capillary Coating(s)
Facilitator: Ewoud van Tricht, Janssen Infectious Diseases and Vaccines 
Scribe: Gordon Freckleton, Eli Lilly and Company

To view notes from this discussion, click here    

 

 

Table 13: Instrument Quality, Reliability and Failure Rate
Notes from this table are unavailable at this time.

 


 

 

 

 

 

 

 

 

 


 

more Calendar

12/4/2017 » 12/5/2017
CMC Strategy Forum Japan 2017

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