Nucleus Biologics Launches Krakatoa® K500: A Pod-Based, On-Demand Media and Buffer Manufacturing System Transforming Scale Bioproduction

• Produces 35–500 liters of sterile media and buffers on demand at point-of-use, reducing cost, complexity, and lead times
• Pod-based, closed single-use system with integrated analytics, QR-code-driven execution, and automated digital batch records to support GMP-compliant manufacturing

SAN DIEGO–(BUSINESS WIRE)–#bioprocess—Nucleus Biologics, a leading provider of custom cell culture solutions and manufacturing technologies for advanced therapies, today announced the launch of Krakatoa® K500, 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.

Media and buffers affect cell therapy potency and yield. These bioprocessing solutions are foundational to every therapy development process, yet they remain a major source of cost, time, and operational complexity. The Krakatoa® K500 supports biologics manufacturers to produce sterile, validated media or buffers in a single automated run. 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.

“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.”

Designed specifically for bioreactor-scale workflows, the Krakatoa® K500 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.

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. This closed, single-use system supports consistent performance, real-time analytics, and full traceability, enabling GMP-compliant operation with audit-ready documentation.

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.

At a glance, Krakatoa® K500 enables:

• On-demand production of 35–500 liters of sterile media or buffers
• Elimination of cold-chain transport and refrigerated storage
• Fully automated, step-away operation with minimal hands-on time
• Pod-based, closed single-use system to reduce contamination risk
• Continuous inline pH, conductivity, and turbidity monitoring
• QR-code-driven formulation execution
• Automated digital batch record generation supports quality compliance

The launch of the Krakatoa® K500 reflects Nucleus Biologics’ broader commitment to reducing the cost and complexity of advanced therapy development. As part of an integrated ecosystem, the Krakatoa® K500 pairs seamlessly with Nucleus Biologics’ custom formulation development, optimization, and GMP manufacturing expertise, enabling customers to move from formulation design to point-of-use manufacturing with greater speed, consistency, and confidence.

The Krakatoa® K500 is available now.

For more information, visit https://nucleusbiologics.com/krakatoa/k-500/.

About Nucleus Biologics

Nucleus Biologics is the leading provider of custom cell-growth media and buffer solutions, tools, and technologies for cell and gene therapy. Its mission is to speed the time from scientific discovery to cure by delivering innovative, transparent, and GMP/Excipient GMP products and services. From design to delivery, we offer an entire digital ecosystem of cell culture solutions that seamlessly interface with one another, facilitating easy formulation, configuration, ordering, and electronic batch record enabled manufacture of media and buffers, while addressing the environmental impacts of cell culture fulfillment.

Contacts

Media Contact:
David Sheehan
Founder, President, and CEO
(858)735-7555
[email protected]