Cambridge Healthtech Institute’s 3rd Annual

Detection, Characterization and Control of Impurities in Biologics

Hot Topics, Emerging Contaminants and Impurities, Case Studies and New Technologies

August 27-28, 2020

 

CHI's conference on Detection, Characterization and Control of Impurities in Biologics conference will bring together leading experts to discuss hot topics, emerging contaminants, and impurities and new characterization tools for impurities that may come from various sources and stages of product development. Through new presentations, high-level poster presentations, and interactive breakout discussions, top scientists will share new insights into characterization and control of various impurities. Some of the hot topics for this year will be impurities in cell and gene therapy products, new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachables, and chemistry and manufacturing controls (CMC) strategy for regulatory filings.

 

Coverage will include, but is not limited to:

 

Novel tools and strategies for detection, characterization, and control of pathogenic impurities (viruses, TSE, trions, mycoplasma, bacteria, endotoxins, etc.):

  • The FDAs studies on innate immune response modulating impurities (IIRMI)
  • Next-Gen sequencing, nano-filtration, and alternative techniques for virus detection and removal
  • New filters and QBP design space approach for viral safety
  • Raw material control strategies for bioprocesses

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

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
  • Raw material control and screening strategies for bioformulations

 

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





Premier Sponsors:

NanotemperTechnologies

Vironova