Nucleus Biologics has introduced the Krakatoa® K500, a bioreactor-scale, pod-based, on-demand media and buffer manufacturing system aimed at transforming how sterile bioprocessing liquids are produced and used at the point-of-use in advanced therapy workflows. The system produces 35–500 liters of sterile media or buffers on demand, reducing cost, complexity, and lead times by enabling co-location of media and buffer manufacturing with bioproduction and eliminating reliance on centralized preparation, extensive validation, complex supply chains, cold-chain transport, and associated refrigerated storage. Combining pre-formulated powder-filled pods, a closed single-use workflow, and fully automated execution with integrated analytics, QR-code-driven operation, and automated digital batch record generation, the Krakatoa® K500 supports GMP-compliant, consistent and reproducible performance with minimal hands-on time and full traceability. Designed for bioreactor-scale workflows, it offers flexibility through two pod sizes (35–100 L and 175–500 L) and produces up to 500 liters in under three hours, while reducing supply chain risk, labor, and acquisition costs and accelerating manufacturing timelines.
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“Krakatoa is regarded as the loudest sound heard on earth. We believe this product can shift the cost model and create a new paradigm for how bioprocessing liquids are delivered to the bioreactor,” said David Sheehan, Founder, President, and CEO of Nucleus Biologics. “This product is the result of 6 years of development, and I am proud of what our team has created. We listened to our customers’ frustrations with the complex process of centralized GMP liquid media manufacturing. With the Krakatoa® K500, we begin a journey to co-locate both media and buffer bioproduction and ultimately intelligence-based improvement of bioprocessing liquids to achieve better yields. As an industry, we must question established norms and lean-out and cost-reduce processes if we want to increase patient access.” The launch underscores the company’s broader commitment to reducing cost and complexity in advanced therapy development, aligning with its digital ecosystem of custom formulation development, optimization, and GMP manufacturing expertise to help customers move from formulation design to point-of-use manufacturing with greater speed and confidence.