Agenda

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Speakers

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  • Theresa Ahern
Tue, 13 May
1345 – 1415

Challenges and Opportunities in Multi-Product Facilities

Good Engineering Practice - Investment Management
Theresa Ahern, Eli Lilly
Caroline Meenan, BioPhorum
This presentation will, outlines the challenges and opportunities associated with multi-product resin re-use (MRR) in biopharmaceutical manufacturing. It focuses on the benefits of MRR, such as sustainability, cost savings, and faster product turnaround, while acknowledging challenges like cross-contamination and regulatory acceptance. The presentation explores current MRR practices, particularly in early clinical phases, and suggests an analogous approach to multi-product equipment use. Key considerations for implementing MRR will be discussed, including product degradation studies, cleaning cycle optimisation, product carryover analyses, and monitoring resin performance. The Presentation will highlight a risk-based approach to MRR implementation and regulatory considerations, including strategies for incorporating MRR into regulatory dossiers. The overall goal is to provide a framework for routine MRR implementation in clinical and commercial manufacturing through collaboration and discussions with Health Authorities.
Theresa Ahern
Director Technical Services / Manufacturing Science
Eli Lilly
Caroline Meenan
Account Manager & Global Change Facilitator
BioPhorum

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.