Cambridge Healthtech Institute’s 7th Annual

Detection and Characterization of Particulates and Impurities

January 19-20, 2021


Cambridge Healthtech Institute’s 7th Annual Detection and Characterization of Particulates and Impurities conference will bring together leading researchers to discuss hot topics, case studies, new technologies to carry out risk assessment and mitigation for impurities arising from products, excipients, processes and packaging. Some of the hot topics for this year will be new and novel technologies, impurities and contaminant detection in cell and gene therapy products and in biotherapeutics, 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 We are looking for cutting-edge tools, research findings and unpublished data to be featured at this forum.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 aggregate and impurities
    • Analytical tools: biophysical and imaging-based methods, advanced mass spectrometry, multiple attribute analysis for identification and impurity profile
    • Virus and pathogens
    • Impurities in cell and gene therapy products
  • 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


If you would like to submit a proposal to give a presentation at this meeting, please click here.


The deadline for priority consideration is July 24, 2020.


All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.


If you are selected as a speaker for this virtual event, we request that you pre-record your presentation and be available during the “live” portion January 19-20 for interactive Q&A and panel discussions.  


For more details on the conference, please contact:

Nandini Kashyap, MPharm

Conference Director

Cambridge Healthtech Institute

Phone: (+1) 781-972-5406 Email:


For partnering and sponsorship information, please contact:

Companies A-K

Jason Gerardi

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-5452 Email:


Companies L-Z

Ashley Parsons

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-1340 Email: