Bio-production of critical compound

Bio-production of critical compounds is essential because, once a diagnostic test is CE-IVDR marked, the design, including all reagents and critical materials, cannot be modified without triggering a new regulatory submission. This means that any dependency on external suppliers creates a long-term vulnerability: if a third party changes a formulation, stops production, raises prices, or becomes unavailable, the certified assay can no longer be manufactured without major regulatory consequences. By internalizing the production of key reagents, companies secure supply continuity, maintain strict lot-to-lot consistency, and protect themselves from unpredictable supply-chain fluctuations.

In the current international geopolitical context—marked by rising instability, export restrictions, and fragile global supply chains—such independence is even more critical. Internal bio-production ensures resilience, regulatory security, and long-term viability of the diagnostic product.