INITS at ESGCT 2026
Oct 27–30, 2026 Hamburg, Germany ~2.5k attendees Website
INITS brings 3 presentations to ESGCT 2026 in Hamburg. Its contributions centre on the regulatory and quality side of advanced therapies, including a risk framework covering nitrosamines, extractables, leachables and elemental impurities. It also sets out a shared manufacturing model and the designation pathways open in Europe and the United States.
| Organization | ESGCT 2026 Attendance |
|---|---|
INITS Mauguio, France | |
Offers CMC, regulatory and quality consulting and runs a shared GMP manufacturing facility where biotechs produce their own clinical batches of biologics and advanced therapies. | Poster Wed Oct 28 1:30pm–3:30pm Comprehensive Risk Assessment Framework for Cell and Gene Therapy Products toward registration: Addressing Nitrosamines, Extractables/Leachables, Elemental Impurities, and Emerging Contaminants for Regulatory Compliance Poster Wed Oct 28 1:30pm–3:30pm The Shared Manufacturing Organization (SMO) model: a multi-technology platform offering flexible and cost-effective alternative for bioproduction Poster Thu Oct 29 2:00pm–4:00pm Strategic Regulatory Designations for Innovative Medicines: An Overview of Existing Pathways in the European Union and the United States, and Opportunities for Cross-Program Compatibility |
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