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Introduction Cell and Gene therapies represent one of the most transformative areas of modern medicine. However, despite their clinical promise, the manufacturing and operational model remains fundamentally artisanal. Production processes are frequently characterized by manual handling, fragmented workflows, and limited automation, making scale-up difficult and costly. Maturity of most supply chains frameworks and integrated business…

Is EMA Opening the Door to Industrial Standards in CGT Manufacturing? Over the past decade, cell and gene therapy (CGT) manufacturing has evolved under a largely bespoke paradigm. Each asset has tended to drive its own process, its own cleanroom configuration, its own raw materials, and often its own exceptions. That paradigm is now under…

The European Commission’s newly announced Critical Medicines Act (CMA) marks a decisive step in the EU’s broader ambition to strengthen pharmaceuticals and biotech supply-chain resilience, reduce critical material dependencies, and safeguard availability and competitiveness. The Biotech and Cell & Gene Therapy (CGT) ecosystem—a sector already defined by fragile supply chains, specialised inputs, and tight coupling…

In the traditional world of clinical trials, a CRO manages the study while a CDMO handles the manufacturing. This model works — until you apply it to Cell & Gene Therapy (CGT). And then, it breaks. Unlike conventional pharma, CGT trials don’t just test a product — they orchestrate a complex, patient-specific supply chain. Every…

CGT manufacturing is breaking out of the cleanroom and moving closer to the patient. What does this mean for healthcare professionals, CDMOs—and biotech strategy itself? From hybrid networks to digital-first production and bedside co-manufacturing, the rules are being rewritten. We’re standing at the edge of a manufacturing revolution in Cell and Gene Therapy (CGT). An…