Pre-Con Workshop Day (27th April 2026)Monday, 27 April 2026 - CET/CEST (Cent Europe Summer, GMT+2)

• "Starting with the End in Mind": Defining the Target Product Profile (TPP), Quality Target Product Profile (QTPP) and CQAs for an early-phase CGT.
• What "Phase-Appropriate GMP" really means for your process and documentation.
• Building the "Knowledge Package": What data is essential? What can wait? (Process description, raw material specs, in-process controls).

• The Analytical Method Transfer "Nightmare": Strategies for transferring and qualifying complex, variable assays (e.g., potency, infectivity, vector copy number).
• Process Transfer: Risk assessments, process mapping, and establishing a "sending" and "receiving" team.
• Data & Digital Transfer: Moving data, electronic lab notebooks, and batch records. How to ensure data integrity from day one.

Breaking down departmental silos with cross-functional dialogue to answer:

• The ICH Q13 Reality: how is the new guidance practically impacting process development, validation strategies, and regulatory filings?

• Is the "digital twin" a practical tool for today or an expensive dream for tomorrow?

• What is the first, most valuable step a company can take to leverage predictive modelling for continuous or intensified processes?

• What is the single biggest organizational or cultural change required to successfully adopt continuous manufacturing?

• How do we build and train the workforce of the future?

• Beyond monoclonals, what will be the killer application for continuous processing in the next 5 years – Cell & Gene Therapies, vaccines, or other novel modalities?

• Device Integration: Connecting formulation science with patient-centric delivery systems. How do you design a formulation for an auto-injector from day one?

• Aseptic Processing: How to approach and maintain aseptic conditions throughout final fill-finish stages to enhance safety?

• Make vs. Buy: A strategic framework for navigating the fill-finish CDMO landscape. When should you build capacity, and how do you select the right partner?  

• The Regulatory Horizon: Preparing for future expectations in aseptic processing, data integrity, and the use of AI in manufacturing.  

• Sustainability: Addressing the growing need for sustainable and PFAS-free consumables in fill-finish operations.  

• "Scale-Out" vs. "Scale-Up": Choosing the right manufacturing strategy for autologous vs. allogeneic therapies.
• The Comparability Conundrum: Designing a robust comparability protocol before you move. What are the regulatory expectations?
• Automation & Closing the System: When and how to move from manual, open processes (flasks, tubes) to closed, automated systems (bioreactors, fill-finish systems).

• The CDMO Partnership: Best practices for selecting, qualifying, and managing a CDMO for a complex CGT.
• Managing the "Human Factor": Training, knowledge management, and fostering a collaborative culture between the sending and receiving sites.
• The Regulatory Playbook: What do the EMA and FDA really want to see in your tech transfer submission?