Day One (13th May 2025)Tuesday, 13 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

The first translation of a research process into GMP is always critical. This presentation covers the case of MUVON Therapeutics, how they managed this first translation, touches on hurdles and presents first results of their clinical trials.

• Early-stage process development & optimization is crucial

• Case studies: Successful optimization strategies & their impact

• QbD & other tools for efficient process development

• Unique challenges of scaling up CGT manufacturing and how real time analytics can be used to aid in scale up

• Implementing PAT (Process Analytical Technology) and other real-time monitoring tools

• Using data to identify and address process deviations proactively
• Building a robust data infrastructure for ATMP manufacturing

• Importance of tech transfer:

• How to approach this

• Best practices

• How automation can be implemented for increased throughput, fewer errors, better control

• Examples of successful automation in CGT manufacturing

• Case study: what was used, done, and the results

• Challenges & considerations

• Approaching questions surrounding equipment & software choice
• Validating new tech into existing processes

• Overview of ATMP regulatory requirements & challenges

• Benefits of early & proactive engagement with regulators

• Best practices for effective communication & collaboration

• How can the industry and regulatory bodies "grow up" together, learning and evolving in tandem.

• Understanding regional differences:

• EMA vs MHRA vs FDA
• Difference in identity testing requirements between regions

• Importance of understanding and complying with updated regulations (e.g. Annex 1)