The European Biomanufacturing Summit was held on May 31 and June 1, 2023, and was attended by industry leaders from multinational biotech and biologics companies, largely from Europe.

The agenda on the first day of the conference included topics related to modernization and digitization of the pharmaceutical industry.  The presenters talked about challenges in transforming quality systems in the wake of rapid digitization in the industry.  Other topics included challenges and solutions for transferring biologics drug production to a CDMO, post‑market requirements for combination products, and the importance of embedding quality culture throughout an organization.  There was an active discussion among the panelists in a roundtable of quality industry leaders focusing on evolving manufacturing and quality approaches for the next wave of therapeutics.

Day 2 of the summit had many interesting presentations.  One of the highlights was a presentation by Dr. Martine Zimmerman from Ipsen that focused on navigating regulatory challenges for bio‑manufacturing companies and how to overcome them.  She skillfully presented different expectations from regulatory agencies around the world, their similarities and differences, and how to navigate them.  She also spoke about how ”expedited pathways” are handled by various regulatory agencies and provided comparisons of them.

Other topics included strategic transformation in manufacturing quality and the supply chain, manufacturing excellence in cell therapy, and ensuring high standards of quality, safety, and performance in preclinical settings, and their alignment with clinical and commercial quality.

There were several lunch-and-learn topics discussed on Day 2 and Lachman Consultants were fortunate to participate in one of them.  This session, on effective quality oversight of CMOs/CDMOs, was moderated by Antoine Maupu from Moderna.  Participants shared their experiences and learned from one another during this lively discourse.  One takeaway from the conversation: The COVID‑19 vaccine’s scale-up speed can be a model for other accelerated‑timeline biologic drugs.

The topics presented and discussed at the summit clearly highlighted current advancements in the biomanufacturing industry, the need and challenges of adapting automation and digitization, challenges for multinational companies dealing with different regulatory frameworks, and finally the importance of establishing and maintaining robust quality culture throughout organizations.