Cambridge Healthtech Institute’s 4th Annual

Detection, Characterization and Control of Impurities in Biologics

August 18-19, 2021

Cambridge Healthtech Institute’s 4th Annual Detection, Characterization and Control of Impurities in Biologics conference will bring together leading scientists from biopharmaceutical industry, academia and government 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.

Coverage will include, but is not limited to:

Regulatory requirements and guidance impurities in novel biotherapeutics, vaccines
Analytical tools
Biophysical and imaging based methods, advanced mass spectrometry, multiple attribute analysis for identification and impurity profile
Virus and pathogens
Impurities in vaccines
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 impurities
Leachables
Process analytical tools

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 January 29, 2021.

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.

For more details on the conference, please contact:

Nandini Kashyap

Conference Director

Cambridge Healthtech Institute

Phone: (+1) 914-471-0598

Email: nkashyap@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-1359