Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics

In this presentation, the evolving landscape of aseptic manufacturing for advanced modalities including mRNA therapeutics, and Antibody-Drug Conjugates (ADCs) will be explored. The session will emphasize phase-appropriate process validation strategies tailored to the unique challenges of early-stage development. Drawing from recent regulatory guidance and practical experience, the talk will dissect the scientific and risk-based approaches to validation, including:

Aseptic Process Simulation (APS) as a cornerstone of sterility assurance

Bracketing and matrixing strategies for batch validation under constrained development timelines

Validation expectations for ATMPs and investigational biologics, referencing EMA and PIC/S

Annex 13 principles

Attendees will gain insights into:

How to balance regulatory expectations with development agility.

The role of risk assessments in defining validation scope.

Strategies to ensure robust sterility assurance while enabling innovation in formulation and delivery technologies.

This session is designed for professionals involved in quality assurance , regulatory affairs, and technical operations, offering a pragmatic framework for navigating aseptic validation in the dynamic field of biopharmaceutical development.

Presented by Francesco Cicirello, Senior Director, Global Quality Compliance – BioNTainer at BioNTech

Francesco Cicirello currently serves as Senior Director, Global Quality Compliance – BioNTainer at BioNTech, where he leads global quality and compliance strategy supporting modular, aseptic manufacturing platforms for advanced biologics. His responsibilities span contamination control strategy (CCS), validation, aseptic process governance, inspection readiness, and the implementation of risk‑based quality systems across multi‑site and international manufacturing networks. Prior to joining BioNTech, Francesco held senior quality leadership roles in both the United States and Europe, including Senior Director of Quality Assurance at Evelo Biosciences in Cambridge, Massachusetts, and Site Quality Head at Adaptimmune in the United Kingdom, supporting development and manufacture of advanced therapeutic products from clinical through commercial stages. Earlier in his career, Francesco served as an Expert Inspector with the Therapeutic Goods Administration (TGA) in Australia, where he was directly involved in GMP inspections and regulatory oversight. He has played a role in regulatory harmonization through elected positions within the Pharmaceutical Inspection Co‑operation Scheme (PIC/S), including Chair of the Working Group responsible for revising PIC/S Annex 2 and PIC/S representative to the EMA Inspectors Working Group. Francesco is an author of PIC/S Annex 2A and 2B and a frequent industry speaker.

Followed by a live question and answer session