Living Medicines: Can Manufacturing Infrastructure Keep Pace with Progress?
Day 1 Next-Gen Bio Stage
06/10/2026 15:45 - 16:10pm
Contributors
Christian Roghi : Founder & Principal Advisor - Bridgyz
Luca Dobetti : Senior Consultant - PMT Italia srl
Living medicines represent a manufacturing challenge fundamentally different from traditional biologics. From microbiome therapeutics to phage therapy and engineered bacteria, these products require continuous viability maintenance, specialised GMP protocols for live organisms, and unbroken cold chain logistics, creating systematic bottlenecks that only a handful of companies can navigate.
Two critical tensions are reshaping commercialisation strategy. First, manufacturing constraints threaten to create a two-tier system where only well, capitalised players with early CDMO partnerships or in-house capacity can compete. Second, the cold chain infrastructure these therapies demand directly conflicts with payer expectations for broad market access and cost-effectiveness. With CDMO capacity scarce and regulatory pathways still evolving, success will belong to companies that solve manufacturing and commercialisation simultaneously, not sequentially.
Key Discussion Points
- Manufacturing paradigm breaks: Living products demand real-time viability monitoring and AI-driven quality control as necessities, not optimisations—creating a CDMO capacity bottleneck that determines which companies can commercialise within realistic timeframes.
- The commercialisation paradox: Unbroken cold chain requirements limit geographic reach and increase costs, directly conflicting with payer demands for cost-effectiveness and broad access—risking a system where living medicines remain niche therapies for privileged populations.
- Strategic positioning: Partnership decisions (in-house vs. CDMO vs. hybrid models) made today will separate market winners from clinical-stage assets trapped in manufacturing feasibility limbo for 3-5 years.