AGENDA AT A GLANCE
8:00
Registration & Coffee
8:50
Chairman’s Welcome Address
Commercialising Cell & Gene Therapies: Scaling for Global Success
9:00
Scaling Viral Vector & Cell Therapy Manufacturing for Commercial Readiness
- Overcoming scale-up bottlenecks in viral vector production (lentiviral, AAV)
- Managing process consistency from development to GMP manufacturing
- Engineering runs, validation, and commercial-scale constraints
- Bridging the gap between small-scale development and industrial production
9:30
Reserved for Service Provider
10:00
Panel Discussion: Building Sustainable CGT Business Models: From Clinical Supply to Commercial Viability
- Impact of funding constraints and milestone-driven investment
- Cost of goods and manufacturing scalability challenges
- Ensuring long-term operational and commercial sustainability
- Aligning manufacturing strategy with market access and growth
10:30
Networking Break
Scaling Cell Therapy Manufacturing
11:10
From Process Development to GMP: Closing the Scale-Up Gap in Cell Therapy Manufacturing
- Translating small-scale processes into reproducible GMP manufacturing
- Managing variability during scale-up and tech transfer
- Engineering runs, validation challenges, and manufacturing constraints
- Improving process consistency across development and commercial sites
11:40
Reserved for Service Provider
12:10
Industrialising Cell Therapy Manufacturing: Automation, Closed Systems & Scalable Platforms
- Streamlining pre-GMP workflows for viral vector–based personalised vaccines
- Automation strategies to reduce complexity and manual intervention
- Building scalable foundations for downstream GMP manufacturing
13:00
Lunch Break
Overcoming Bottlenecks in Viral Vector Manufacturing
14:00
Scaling Viral Vector Manufacturing: From Development to GMP Production
- Addressing scale-up challenges in lentiviral and AAV production
- Managing process variability between R&D and GMP environments
- Bridging development processes with commercial manufacturing requirements
- Reducing risk during tech transfer and engineering runs
14:30
Reserved for Service Provider
15:00
Improving Yield, Consistency & Cost Efficiency in Viral Vector Production
- Enhancing process robustness and reproducibility at scale
- Tackling low yields in complex vector manufacturing processes
- Optimising upstream and downstream performance for efficiency gains
- Balancing cost pressures with clinical and commercial demand
15:30
Networking Break
16:00
Roundtable Discussions
- Can CGTs Become Truly Commercially Viable?
- Fixing the Scale-Up & Tech Transfer Gap in CGT
- What Does “GMP” Really Mean for Early-Phase ATMPs?
- Industrialising CGT: Automation vs Practical Reality
- Building Scalable CGT Manufacturing Models for the Next Decade
17:00
Cocktail Reception
17:15
End of Day 1
8:50
Chairman’s Welcome Address
Quality, GMP & Regulatory Control in CGT Manufacturing
9:00
Rethinking QA in CGT — From End-Point Release to Continuous Quality Control
- Shift from traditional end-point QC to in-process quality monitoring
- Real-time process data to prevent deviations instead of reacting via CAPA
- High variability in CGT driving increased deviation and investigation burden
- Balancing speed-to-patient with GMP compliance requirements
9:30
Reserved for Service Provider
10:00
Navigating GMP & Regulatory Complexity in Cell & Gene Therapy
- Non-harmonised expectations across EMA vs FDA and global regulators
- Evolving GMP expectations for early-phase vs commercial CGT manufacturing
- Assay validation, comparability, and starting material scrutiny challenges
- Regulatory uncertainty during tech transfer from academic to GMP environments
10:30
Networking Break
Bridging the CGT Scale-Up & Tech Transfer Gap
11:10
Why CGT Tech Transfer Fails — From R&D to GMP Reality
- Fundamental mismatch between lab-scale and GMP manufacturing environments
- Limited opportunity for full-scale optimisation due to cost and material constraints
- Environmental and operational differences between development and production sites
- Hidden failure points emerging only during GMP execution
11:40
Reserved for Service Provider
12:10
Scaling Non-Linear Biology — Managing Process Transfer in Living Therapies
- Non-linear scale-up behaviour in cell and gene therapies
- Why “platform processes” still require product-specific adaptation
- Bridging variability between sites, teams, and manufacturing systems
- Building realistic expectations for scale-up success rates
13:00
Lunch Break
Novel Biosafety & Contamination
14:00
Panel Discussion: How can CGT manufacturers strengthen biosafety controls without slowing development?
- Managing contamination risk across donor material, starting materials, viral vectors, and open processing steps
- Balancing rapid methods, assay sensitivity, and GMP/regulatory expectations
- Strengthening investigation and decision-making pathways when atypical results arise
- Building scalable contamination-control strategies as programmes move from early clinical to commercial supply
14:30
Reserved for Service Provider
15:00
Building a Phase-Appropriate Biosafety Strategy for Cell and Gene Therapy Manufacturing
- Defining biosafety-testing needs according to modality, process risk, and clinical stage
- Integrating cell-bank, raw-material, in-process, and product testing into one coherent control strategy
- Reducing turnaround-time risk while maintaining confidence in product safety and quality
- Preparing biosafety methods and controls for tech transfer, scale-up, and commercial readiness
15:30
Networking Break
Supply Chain, Logistics & Commercial Readiness
16:00
Managing Critical Material Shortages in CGT Manufacturing
- Viral vectors, plasmids and raw material bottlenecks
- Long lead times and limited supplier base
- Impact of material constraints on GMP production timelines
- Practical mitigation strategies used by manufacturers today
16:30
What Breaks When CGTs Move from Clinical to Commercial Supply?
- Tech transfer failures impacting supply continuity
- Scaling manufacturing networks under GMP constraints
- Misalignment between development timelines and manufacturing reality
- Operational challenges in sustaining commercial supply
17:00
Chairman’s Closing Remarks
17:15
END OF CONFERENCE
