Q1. Could you start by giving us a brief overview of your professional background, particularly focusing on your expertise in the industry?

With 15+ years in biopharma R&D and CDMO strategy, I’ve led cell line development, viral vector manufacturing, and mRNA platform projects across Lonza, Pfizer, and Syngene. I advise clients on technology adoption, CDMO selection, and commercialization strategy. 

Q2. What is the projected growth of the global cell line development market through 2034? Which regions are leading in the adoption of cell line development services?

The global cell line development market is expected to grow at ~ a 10%-12 % CAGR, reaching over $14B by 2034, driven by biosimilars, mAbs, and gene therapies. 

North America and China are leading adoption, with the EU following closely. 

Q3. How are AI-driven platforms like CYTENA’s C. STATION transforming cell line development?

AI-powered systems like C. STATION accelerate high-throughput single-cell cloning and predictive analytics for high-producing clones, reducing timelines and variability. They improve traceability and reduce manual interventions. 

Q4. What impact will the anticipated surge in autologous and allogeneic cell and gene therapies have on viral vector batch production models?

The CGT boom is straining viral vector capacity, shifting the model from batch to modular, closed, and continuous systems. Allogeneic platforms, in particular, demand large-scale, consistent production. 

Q5. What are the regulatory challenges associated with mRNA therapeutics?

Key hurdles include platform-specific CMC guidance, raw material traceability (e.g., capping enzymes, modified nucleotides), and analytical standardization. EMA and FDA are converging, but gaps remain. 

Q6. What is the projected growth of the personalized medicine market? What technological advancements are facilitating personalized medicine?

The market is projected to surpass $800B by 2030, driven by AI-enabled diagnostics, single-cell omics, and CRISPR-based interventions. Liquid biopsies and real-time sequencing (e.g., ONT) accelerate precision therapy.

Q7. If you were an investor looking at companies within the space, what critical question would you pose to their senior management?

Some questions I would like to ask are: 

• How are you derisking your platform through tech differentiation, manufacturing readiness, and regulatory foresight?
• What’s your long-term moat—IP, talent, or partnerships? 
• Are they prepared for both pipeline attrition and rapid scale-up if a product hits? 
• Are you leveraging companion diagnostics or omics-driven stratification in your pipeline?
• How do you plan to differentiate in a crowded biologics pipeline?
• Are your current CLD workflows optimized for speed, scalability, and regulatory transparency? 
• Are your vector manufacturing partners prepared for parallelized production and GMP-compliant scalability? 
• How robust is your regulatory strategy for evolving mRNA QC and release testing requirements?