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WCBP 2015: Round Table Notes
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Below you will find links to notes taken during the Round Table session at WCBP 2015.  

If you have questions regarding the links, please contact Project Coordinator Anna Lingel (



Table 1 - Subvisible Particle Methods Click Here 
Table 2 - Clinical Support of CMC Decision  Click Here
Table 3 - In-vitro Replacements for In-vivo Assays and New Technologies for Vaccine Characterization  Click Here
Table 4 - Analytical Methods - Is the Method Design Robust & "Suitable for Intended Purpose?"
             Use of DOE in Method Development
Click Here 
Table 5 - Protein Aggregation Click Here
Table 6 - Bioassays Click Here
Table 7 - Immunogenicity Assays Click Here 
Table 8 - Residual Impurities Other than HCP Click Here
Table 9 -  Method Transfer Click Here
Table 10 - Hot Topics in Pre-approved Inspections Click Here 
Table 11 - Hot Topics in GMP Inspections  Click Here
Table 12 - Due Diligence Assessments Click Here
Table 13 - Outsourcing to CMO's and CTO's Click Here
Table 14 - Extractable / Leachable Risk Assessment  Click Here
Table 15 - Product Specified Monographs  Click Here
Table 16 - Breakthrough Products and Accelerated Development Click Here 
Table 17 - Forced Degradation and Accelerated Stability Studies  Click Here
Table 18 - Global Excipient Testing Requirements Click Here
Table 19 - Analytical Considerations for Comparators Used in Clinical Studies  Click Here
Table 20 - Biosimilars #1 Click Here 
Table 21 - Biosimilars #2 Click Here 
Table 22 - CMC Statistics  Click Here
Table 23 - Drug Product Comparability Assessments  Click Here
Table 24 - Clonality of Cell Lines Click Here
Table 25 - The Future of WCBP Click Here 
Table 26 - Oligonucleotide Therapeutics and mRNA Click Here 
Table 27 - Control Strategies for Personalized Medicines  Click Here


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