Day 1
AGENDA
07.35 – 08.20
Registration
08.20 – 08.30
Welcome & Chairperson’s Opening
Remarks for Day One
Digitalization, modeling, and machine learning: Pillars for development of next generation bioprocesses
- 1. The talk will describe how MSD is strategizing the use of digitalization, modeling, and machine learning tools for development of next generation bioprocesses.
- 2. The discussion would include the applicability and suitability of various tools relevant to data aggregation, modelling and simulation, as well as machine/deep learning.
- 3. Relevant case studies in different areas of development and manufacturing (upstream and downstream) would be shared.
- 4. Finally, Examples will be provided how the aforementioned techniques are being integrated with high throughput setups and PAT applications for speedy development and enhanced process understanding.
Insights on industrial manufacturing of allogeneic cell therapies
- 2D cultivation of allogeneic cell therapies
- Scale up technologies for 2D cultures
- Challenges of industrial scale manufacturing in 2D
- Next gen processes to overcome scale limitations
Case Studies with the NEW Planova™ Virus Removal Filters: “FG1 – a rapid-flux filter” and “S20N – a filter for challenging solutions
This presentation includes detailed case studies, highlighting the filters reliability and suitability for multi-specific antibody processing.
- Planova S20N offers high flux and stable virus filtration, ideal for hydrophobic and multi-specific antibodies, even under low pressure and extended use.
- Planova FG1 delivers rapid filtration with >1,000 LMH initial flux, high throughput, and robust virus removal.
Downstream Development
11.30 –13.00
One to One Meetings & Investment Areas
- Cell Culture
- Upstream Processing
- Contamination Control Technologies (Cleaning, Sterilization and Disinfection)
- 2D & 3D Models
- Cell Therapy
- Gene Editing
- Stem Cell Derived Therapies
- Gene Therapy
- Viral Vectors Manufacturing & Testing
- CMC Development
- ATMP Development
- CAR T Cell Manufacturing
- CAR T Analytical Testing
- Automation
- Digitalisation/Industry 4.0
- Quality
- MSAT
- Contract Manufacturing
- Cell and Gene Therapy Reagents
- PAT/Real Time Monitoring
- Analytical Development
Upstream Sciences
11.30 – 12.00
Optimizing mRNA Therapeutic Purification: A Case Study Using
Seplife® Oligo dT(20) Affinity Resin
- A scalable affinity chromatography solution designed to meet the growing global demand for high-purity mRNA used in vaccines and therapeutic applications.
- Importance of resin stability, ligand density, and batch consistency for downstream capture of mRNA at clinical and commercial scale.
- Case Study – Purification of mRNA transcripts up to 5,000 nucleotides using Seplife® Oligo dT(20), achieving >90% recovery, 98% purity, and 4.7 mg/mL binding capacity.
- Resin designed for alkaline stability and reproducibility, offering a robust platform for RNA-based therapeutics in large-scale biomanufacturing.
12.00 – 12.30
Exploration of Analytical Methods to Optimize Gene Therapy Manufacturing: A Comparative Case Study
- The importance of analytics in gene therapy manufacturing
- The existing analytical challenges of gene therapies
- Case study: Exploration of analytical methods to optimize gene therapy manufacturing
- Case study findings and discussion
12.30 – 13.20
13.20 –14.10
Roundtable Discussions:
For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice
1. Automating CART-T Cell Manufacturing process to speed up production – are we there yet? . What does the industry need to increase manufacturing capacity of Allogenic Cell Therapies.
2. Taking Control of Your Manufacturing: Streamlining Workflows with Comprehensive Partnership – Integrated view on how to scale up and scale up efficiently
3. Best practices for successful tech transfer based on lessons learned, elements of comparability, addressing skills gaps and the pitfalls
4. Overcoming Gene Therapy Development Barriers with Enhanced Transfection and Lower Production Costs.
5. Strategies in CDMO Partner Selection and Manufacturing Scale-Up for a Commercial Cell & Gene Therapy
14.10 – 14.40
Immuno-STATs™: a novel class of T cell engagers for depleting B cells in autoimmune diseases
- Immuno-STATs are a new class of TCR-selective engagers for selective modulation of disease-relevant T cells
- CUE-100 series Immuno-STATs have been clinically validated in oncology, and have demonstrated significant increase in efficacy (ORR and mPFS) vs SoC
- This presentation will focus on a new series of Immuno-STATs, CUE-500, that are designed for re-directing the protective virus-specific T cells (VSTs) to deplete B cells
- The MoA of CUE-500 series provides unprecedented selectivity for exploiting the killing potential of VSTs for B cell depletion, and positions this class of biologics as an attractive alternative for CAR-T approaches
14.40 – 15.10
Supply Chain Resilience & Decentralized Manufacturing: Ensuring Commercial-Ready CGT Delivery
- Building redundancy strategies for critical raw and ancillary materials
- Enabling end-to-end traceability and chain-of-identity across distributed manufacturing networks
- Managing quality risk in point-of-care and decentralized production models
- Strengthening cold-chain logistics, stability planning, and global supplier qualification
- Decision frameworks to balance speed, cost, and reliability in commercial supply deployment
15.10 – 15.55
One to One Meetings & Investment Areas
- Cell Culture
- Upstream Processing
- Contamination Control Technologies (Cleaning, Sterilization and Disinfection)
- 2D & 3D Models
- Cell Therapy
- Gene Editing
- Stem Cell Derived Therapies
- Gene Therapy
- Viral Vectors Manufacturing & Testing
- CMC Development
- ATMP Development
- CAR T Cell Manufacturing
- CAR T Analytical Testing
- Automation
- Digitalisation/Industry 4.0
- Quality
- MSAT
- Contract Manufacturing
- Cell and Gene Therapy Reagents
- PAT/Real Time Monitoring
- Analytical Development
Workshops
15.55 – 16.25
Development of a Robust and Scalable AAV8 Production Platform: Enhancing Vector Yield and Purity through Optimized Bioprocessing Techniques
- Adeno-associated virus (AAV) vectors are pivotal in gene therapy, but production faces significant challenges, including scalability, low recovery rates, and the need for effective separation of empty and full capsids
- Study presented will include a comprehensive AAV8 production platform developed with CDMO Matica Biotechnology
- Study addressed industry pain points through innovative upstream and downstream processes
- Downstream process incorporates various Sartorius products that enhance virus recovery and purity
- The combination of data analytics and screening tools allowed for optimization of process parameters in small scale, results could be translated to a 50L scale
- Platform meets current industry demands, and provides a foundation for future advancements in gene therapy vector production
16.25 – 16.55
What BioPharma Needs from IT: Data Harmonization
- The pace of innovation in cell-gene therapy is moving faster than the progress in data architectures for the BioPharma space.
- That’s because the 100+ instruments used in drug production don’t share a common data format.
- The lack of harmonized data is the single biggest risk to data integrity – because it requires significant human intervention.
- IT architectures have evolved: client-server, web, cloud, mobile, but not far enough for today’s biopharma innovators.
- To keep pace and prepare for the era of AI, BioPharma needs software-defined data architecture, not today’s hardware-defined architectures.
- A software-defined architecture harmonizes data from any instrument by design for lab information and management systems.
- IT needs to catch up with Biopharma innovators.
16.55 – 17.25
Reducing Product Loss in the Biomanufacturing Cold Chain: The Critical Nature of a Durable Primary Packaging Solution
- As more and more therapies require temperatures down to and below -80 degrees Celsius, the need for primary containers that can maintain integrity throughout the cold chain has become more critical than ever. Testing and data will be presented that demonstrates that primary containers have a range of failure modes even when protective secondary packaging is utilized.
- Understanding these failure modes and ensuring primary packaging is validated for cold chain application (such as Frozen Impact Durability, Freeze/Thaw cycle, Long-Term Frozen Storage and shipping and distribution testing) allows end users to minimize the potential for integrity problems during high volume production.
Progresses and challenges of CAR-T Cell Therapy Manufacturing Development
- Background and significance of autologous CAR-T cell therapy
- Key CMC considerations to CAR-T product success
- Challenges and current solutions to autologous CAR-T manufacturing
- Emerging platforms for potentially revolutionizing the CAR-T status quo
Please Note: Workshop, Agenda, Speakers and Participants can be subject to change
