Cambridge Healthtech Institute’s Inaugural

Detection, Characterization and Control of Impurities in Biologics

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

August 16-17, 2018


Cambridge Healthtech Institute’s Inaugural Detection, Characterization and Control of Impurities in Biologics conference will bring together leading scientists from biopharmaceutical industry, academia and government 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 and manufacturing. Through new presentations, informative panel discussions, 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 new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings.

Topics covered will include, but are not limited to:

  • Novel tools and strategies for detection, characterization and control of pathogenic impurities (viruses, TSE, trions, mycoplasma, bacteria, endotoxins etc.)
  • The FDA’s studies on innate immune response modulating impurities (IIRMI)
  • Next-Gen Sequencing, nano-filtration and alternative techniques for virus detection and removal
  • New filters and QbD 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 bioformulation

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

The deadline for priority consideration is February 2, 2018.

All proposals are subject to review by session chairmen 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.

For more details on the conference, please contact:
Nandini Kashyap

Conference Director

Cambridge Healthtech Institute

Phone: 781-972-5406

Email: nkashyap@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z

Carolyn Benton

Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-5412
Email: cbenton@healthtech.com