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Immunogenicity & Bioassay Summit

The 18th Annual Immunogenicity & Bioassay Summit, hosted by CHI | Cambridge HealthTech Institute, takes place October 19-22, 2026 in Alexandria, VA, with a virtual attendance option. The program covers immunogenicity risk assessment, bioassay development, ADA/NAb strategies, bioanalytical validation, clinical strategies, and regulatory expectations, featuring FDA CDER/CBER speakers and industry presenters.

Dates
October 19, 2026 — October 22, 2026
Hours
9:00 AM – 6:00 PM Unverified
Frequency
annual

Please double-check the dates and location on the organizer website before attending.

Immunogenicity & Bioassay Summit (18th Annual)

Hosted by CHI | Cambridge HealthTech Institute, the 18th Annual Immunogenicity & Bioassay Summit runs October 19-22, 2026 in Alexandria, VA, with a virtual attendance option.

Focus

The event centres on immunogenicity risk assessment, bioassay development, clinical strategies, and regulatory expectations. Key themes include immunogenicity prediction, mitigation and control; ADA / NAb (anti-drug antibody / neutralizing antibody) strategies; bioanalytical method development and validation; statistical methods for ligand binding and cell-based bioassays; and emerging therapeutic modalities.

Program

The schedule is organised into two parallel streams - Immunogenicity and Bioassays - combining symposiums, training seminars, short courses, and a poster hall across the four days.

Speakers

Eight confirmed FDA speakers from CDER and CBER present alongside industry experts from Regeneron, Novartis, GSK, Merck, AstraZeneca, Eli Lilly, and Epivax.

Organizer

CHI | Cambridge HealthTech Institute, 250 First Avenue, Suite 300, Needham, MA 02494 (a division of the Cambridge Innovation Institute).

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