Nucleus Biologics launched the Krakatoa® K500, which the company says is the first bioreactor-scale, pod-based media and buffer manufacturing system designed to deliver sterile solutions on demand and at point-of-use. The system enables the co-location of cell culture media and buffer manufacturing and bioproduction.
The Krakatoa K500 supports biologics manufacturers to produce sterile, validated media or buffers in a single automated run, according to a company spokesperson, who added that this eliminates reliance on centralized media preparation, extensive validation processes, complex supply chains with expensive consumables, and cold-chain transport that yields limited shelf-life liquids.
By combining preformulated powder-filled pods, a closed single-use workflow, and fully automated execution, the system simplifies operations while delivering consistent, reproducible performance with every batch, explained David Sheehan, founder, president, and CEO of the company.
![Krakatoa K500. 1) Insert and Connect Pod. Single-use pod is equipped with aseptic connectors and QR identification. 2) Automated Mixing. Inner bag expands and media or buffer is mixed to full volume per encoded parameter. 3) In-process Analytics. Continuous inline monitoring of pH, conductivity, and turbidity. 4) Sterile Filtration. Aseptically connected 0.2 μm filtration directly to surge pump. 5) Sample Verification. Draw analytical samples from surge bag. 6) Bioreactor. Pump sterile solution directly from surge bag into the bioreactor. [Nucleus Biologics]](https://www.genengnews.com/wp-content/uploads/2026/02/Ecosystem2-300x169.jpg)
“We believe this product can shift the cost model and create a new paradigm for how bioprocessing liquids are delivered to the bioreactor,” continued Sheehan. “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.”
Designed specifically for bioreactor-scale workflows, the system reportedly requires less than 15 minutes of hands-on time and produces up to 500 liters in less than three hours. Two standard pod sizes, 35–100 liters and 175–500 liters, provide flexibility to align production volumes with specific process needs, noted Sheehan.
He pointed out that each run is initiated through a QR-code-driven workflow that integrates automated processing, standardized formulations, continuous inline monitoring, and automated digital batch record generation. The closed, single-use system supports consistent performance, real-time analytics, and full traceability, enabling GMP-compliant operation with audit-ready documentation, said Sheehan.
By eliminating cold-chain transport, refrigerated storage, and excess infrastructure requirements, the Krakatoa K500 reduces supply chain risk, labor, and overall media and buffer acquisition costs while accelerating manufacturing timelines, according to the company.
