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Exploring the Cutting Edge: Insights from the E&L and Toxicology Event



We had the pleasure of being able to attend Extractables & Leachables (E&L) Europe in Amsterdam this month which provided a deep dive into the scientific, technical, and regulatory landscapes shaping these crucial sectors. Hosted by leading experts, the event unveiled critical learnings, debated industry shifts, and shed light on upcoming regulatory changes.

Scientific and Regulatory Insights

The discussions reverberated with talks on Biologics & Cell and Gene Therapies (C&GT), emphasizing the imminent need for distinct guidelines, especially with USP 665's impending arrival in 2026. The intricacies of the manufacturing process for these entities, involving storage, single-use systems, and bioreactors, highlight elevated risks at every phase. Amid debates over risk assessment versus economic feasibility, consensus leaned towards scrutinizing high-risk leachables, especially within storage bags and filters.

While Artificial Intelligence (AI) surfaced in discussions, a pessimistic aura loomed regarding its industry dominance. However, its potential in summarizing extensive datasets and identifying compounds with unknown toxicity data emerged as a silver lining amidst concerns about misleading references.

Insights into potential Pressurised Metered Dose Inhaler (pMDI) propellants—1234ze & 152a—fostered discussions on their suitability from an E&L perspective, promising advancements in this domain with the need to find alternative propellants with lower global warming potential (GWP).

A compelling talk spotlighted leachables stemming from unforeseen sources in plastic packaging, including glue and tape, raising eyebrows on previously unconsidered aspects in their extractables studies.

Toxicology and Analytical Chemistry Focus

Toxicology discussions delved into the "read-across methodology" and the introduction of ISO 10993-17 amendment, emphasizing toxicological screening limits (TSLs) as cumulative exposure doses over specified periods without inducing significant health effects.

Analytical chemistry sessions showcased case studies on polysorbate degradants and the combined use of CAD and MS/MS, unveiling novel pathways for analysis.

Community Insights and Networking Opportunities

Beyond the scientific rigors, the event fostered a tightly-knit community atmosphere, offering ample networking chances, averaging about four interactions daily during coffee breaks. The gathering served as a rendezvous for E&L and toxicology aficionados to exchange industry insights rather than merely scouting for suppliers.

Final Thoughts

Reflecting on this insightful event, it emerges as a must-attend for industry insiders seeking knowledge and networking, active participation promises invaluable discussions and networking opportunities. For small to medium-sized enterprises (SMEs) with confident networking skills, this symposium stands as a treasure trove of insights and potential collaborations.

The symposium's fusion of scientific depth, regulatory discourse, and a closely-knit community vibe solidified its position as an indispensable event in the E&L and toxicology landscape.