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2015

Invalid Rates Workshop

Workshop Report Kennett Watzig Sänger-van de Griend 2015
Detecting Reversible Concentration-Dependent Self-Association in a Monoclonal Antibody and a Preliminary Investigation to Eliminate It

Case Study Wei et al. 2015
Higher Order Structure Characterization During Protein Therapeutic Candidate Screening

Case Study Jiang et al. 2015
Utilization of Differential Scanning Calorimetry to Elucidate Critical Protein Structural Changes Resulting from Oxidation

Case Study Arthuer Dinh Gabrielson 2015
Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry

Case Study Weiss et al. 2015
Troubleshooting Report - CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks

Troubleshooting CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost …
Summary of 2015 CMC Strategy Forum Japan

CMC Summary Paper: CMC Strategy Forum Japan 2015
Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification: Technical and Regulatory Considerations

CMC Summary Paper: CMC Strategy Forum North America Summer 2015
More Structured, Interactive Process to Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia

CMC Summary Paper: CMC Strategy Forum Latin America 2015

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For 2021 meetings, content will be available for one year after the program. For 2022 and beyond, content will be available for three months.