Unlock the Operational Value Chain of your CGT Operations
Empowering CGT innovators with actionable operational and business insights to streamline supply chains, enhance efficiency, achieve and run commercial scale operations for their therapies effectively.
Latest Blog Posts
Stay informed and inspired with our latest industry blog posts and technology reviews. Discover insights, tips, and trends across various topics.
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From Regulatory Signal to Operational Design Principle:
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…
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EU Critical Medicines Act. Biotech Operational Implications.
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…
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Beyond the CRO: Why CGT Trials Need a New Operational Model.
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…
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The Future of CGT Manufacturing: Localised, Intelligent, and Radically Collaborative
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…
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Navigating the Evolving Challenges of Cell and Gene Therapy Supply Chains: Trends, Integration, and Future Directions
Cell and gene therapies represent a revolutionary leap in medicine, offering the potential to treat previously untreatable diseases and transform patient outcomes. However, their complex nature presents significant challenges across the entire biotech industry. As these therapies transition from the research phase to commercial scale, the associated supply chain and manufacturing hurdles have become critical…
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How Automation Is Revolutionising CGT Manufacturing
The rise of cell and gene therapies (CGT) has introduced groundbreaking treatments, but scaling their manufacturing has proven to be a major hurdle. Traditional production methods have struggled to meet the rising demand for these complex therapies. Enter automation—ushering in a new era where speed, precision, and efficiency redefine the manufacturing process. With robotic systems,…
