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Cambridge Healthtech Institute’s 6th Annual

Detection and Characterization of Particulates and Impurities

January 21-22, 2020

Part of the Analytics & Impurities pipeline

 

Cambridge Healthtech Institute’s 6th Annual Detection and Characterization of Particulates and Impurities conference will bring together leading researchers to discuss hot topics, case studies, new technologies, and strategies to carry out risk assessment and mitigation for impurities arising from products, excipients, processes and packaging. Through new presentations, informative panel discussions, high-level poster presentations, and interactive discussions, top scientists will share new insights into detection, characterization and control of various impurities. Some of the hot topics for this year will be new and novel technologies contaminant detection, host cell proteins, lipases and enzymatic degradation, particles and aggregates, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings. We are looking for cutting edge tools, research findings and unpublished data to be featured at this forum.

 

Coverage will include, but is not limited to:

  • Regulatory requirements and guidance on particles and impurities
    • Risk of immunogenicity posed by aggregates and impurities
    • Analytical tools: biophysical and imaging based methods, advanced mass spectrometry, multiple attribute analysis for identification and impurity profile
  • Virus and pathogens
  • Novel tools and strategies for detection, characterization and control of process-related impurities
    • Host cell proteins, host cell DNA
    • Inducers, antibiotics, media components
    • Reagents or metals which can enhance oxidation or clipping reactions
    • Leachables from single use systems
    • Understanding mechanism of interaction between E&L and proteins and its impact on stability, potency and immunogenicity of drug substance and drug product
  • New tools and strategies for detection, characterization and control of product-related impurities
    • Molecular variants, precursors, degradation products, aggregates, high molecular weight species (HMW), deamidation products, clipped species
    • Detergents and surfactants characterization
    • Removal/control of lipase or other enzymatic impurities which impact surfactant stability/degradation
    • Formulation components, raw materials control and excipient related impurities    

 

* The program is subject to change without notice, due to unforeseen reason.







2020 Conferences & Training Seminars