Virtual Europe Discussion Group
The Virtual Europe Discussion Group provides opportunities for the broader community of industry, academic, and regulatory professionals to meet and share ideas and experiences. The group will discuss scientific challenges in the field of biopharmaceutical development and regulation with a focus on Europe.
The Virtual Europe Discussion Group goals include:
- Share learning across industry, academia, and health authorities across Europe, with a focus on speakers from across the region.
- Generate new scientific and technical insights and solutions for developing biopharmaceutical products in the future.
- Contribute to the expansion of CASSS’ mission, vision, influence, and community in Europe.
Click on the sections below for detailed information:
Navigating the Stricter Protein Content Requirement for Therapeutic Biologics | 11 December 14:00 CET | Virtual
Join us virtually from anywhere in the world on 11 December at the Virtual Europe Discussion Group (VEDG) for a discussion on "Navigating the Stricter Protein Content Requirement for Therapeutic Biologics". Network with local and international CASSS members. Registration for this free opportunity closes 9 December.
Attendance and Substitution Policy
CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.
Navigating the Stricter Protein Content Requirement for Therapeutic Biologics | 11 December 14:00 CET | Virtual
Protein content is a critical quality attribute for therapeutic biologics and is controlled throughout drug substance (DS) and drug product (DP) manufacturing. Recent regulatory discussion around the maximum acceptable variability of active substance content in the European Union has renewed attention on whether a generic ±5% criterion is appropriate for recombinant therapeutic proteins, including monoclonal antibodies. Across industry, a ±10% range around the target protein content has been widely applied and accepted, while manufacturing processes and analytical procedures are controlled through substantially tighter internal limits. This discussion forum examines the tighter limits being requested for therapeutic biologics by the EMA and the impact this has to manufacture and specification setting. The discussion forum will look at case studies where implementation of the tighter limit has been challenging to achieve, and whether setting these tighter specifications for biologics is meaningful.
2026 Speaker Presentations
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If you have any questions about this media kit, please reach out to Renee Olson.
Register Now
Save your spot for the Virtual Europe Discussion Group on 11 December 2026. Registration for this free opportunity by 9 December 2026.
CASSS On Demand
Access approved content from past meetings in the CASSS On Demand platform. CASSS members have access to all available presentation recordings. Visit ondemand.casss.org, login to your account, and select from the list of meetings to begin.