The Future of Media and Buffer Manufacturing Begins Now

Enable co-location of cell culture media and buffer manufacturing and bioproduction with Krakatoa K500, the first bioreactor-scale pod-based manufacturing system. Produce up to 500 liters of sterile solutions on-demand in less than 3 hours.

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Pod Loading Bay

Insert pre-formulated pod to solubilize and dispense up to 500 liters of media

Integrated Sensors

Real-time and continuous Inline monitoring (temperature, pH, conductivity)

Mixing System

Mixing bag is expanded and hydration occurs. Mixing is performed with a magnetic Impeller

Single-Use Tubing

Tubing path from K500 to surge bag

Inline Filter

Aseptically connected 0.2 μm filtration reduces contamination risk and ensures every batch meets the highest quality

Intuitive Touchscreen

Fully automated solubilization process and navigation for pod runs

Transform Your Media and Buffers for Bioproduction

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Lower Acquisition Cost
Powder-filled, single-use pods and on-demand production reduces the number of consumables required, eliminates cold-chain transport, and significantly reduces incoming QC.
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Streamline Operations
Automated, closed, single-use workflows with integrated sterile filtration, inline monitoring, and digital batch records remove the need for prep tanks, refrigerated storage, cleaning, and manual documentation.
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Shorten Lead Times

Produce 35–500 liters of sterile media or buffers in as little as 3 hours on-site and on-demand, eliminating procurement, shipping, and on-site storage.

Step Into the Future of Bioproduction

Despite advances in upstream and downstream processing, cell culture media and buffer manufacturing has remained largely unchanged relying on manual media and buffer preparation, liquid suppliers, and complex logistics. Krakatoa K500 ushers in a new era: bioreactor-scale sterile media and buffer manufacturing on-demand and at point-of-use within 3 hours.

Proven Functionality

Amino Acid Profile Confirms Solubilization Consistency

Consistency of your cell media product is critical to the success of your development. Our protocols for pod filling and solubilization ensure media with equivalent quality and solubilized ingredient specifications as off-the-shelf media. In a direct comparison of Krakatoa mixed media and off-the-shelf media (DMEM/F-12 supplemented with 10% FBS), both media showed equivalent levels of amino acids when compared to a control specification.

Krakatoa Media Performs Equivalently to Off-the-Shelf Media

Producing media sustainably is our goal to cure the planet, but producing quality media is a necessity to cure patients. Krakatoa media performs comparably to off-the-shelf media when analyzing cell proliferation and population doubling. In a comparison of off-the-shelf DMEM/F-12 supplemented with 10% FBS vs Krakatoa DMEM/F12 supplemented with 10% FBS on MSCs, our data shows equivalent cell confluence % from Day 0 through Day 6.

Krakatoa Can Manufacture Complete Media with Large Proteins

Krakatoa was evaluated for its capability in mixing media supplemented with large proteins. In our study, we manufactured CMRL media, a complex media formulation supplemented with insulin and transferrin. Media was tested for protein content after filtration and it showed comparable levels to the specification, proving that Krakatoa is capable of mixing, dispensing, and filtering advanced media.

Krakatoa K500 process analytics

Integrated Analytics and Digital Systems 

Controlled workflows, inline QC sensors for pH, conductivity, and turbidity monitoring, and automatic digital batch record generation ensure the delivery of consistent, reproducible solutions with audit-ready documentation to support GMP-compliant manufacturing for every batch.

Press and Play Automation

Designed to produce sterile GMP cell culture media and buffers on demand, Krakatoa K500 is an easy-to-use, fully closed, single-use manufacturing system that delivers cell culture solutions directly into a surge bag.

Krakatoa K500 pod loading

STEP 1

Load the Pod and Tubing

Click “Create”. Krakatoa K500 will prompt you to load the preformulated powder pod and connect the single-use tubing.

Krakatoa K500 automated solubilization screen

STEP 2

Automated Solubilization

The Krakatoa K500 reads the QR code on the pod to execute the workflow (hydration, mixing) according to the encoded parameters.

Krakatoa K500 solutions going through filter

STEP 3

Solution is Dispensed

Liquid media or buffer is extracted through the inline 0.2-micron filter and into a surge bag, where samples can be collected for further testing prior to pumping into the bioreactor.

krakatoa k500 ecosystem

STEP 1

Insert and Connect Pod

Insert single-use pod into pod loading bay. Pod is equipped with aseptic connectors and QR identification.

STEP 2

Automated Mixing
Inner bag expands and media or buffer is mixed to full volume per encoded parameters.

STEP 3

In-process Analytics
Continuous inline monitoring of pH, conductivity, and turbidity.

STEP 4

Sterile Filtration

Aseptically connected 0.2 μm filtration directly to surge bag.

STEP 5

Sample Verification

Draw analytical samples from surge bag.

STEP 6

Bioreactor
Pump sterile solution directly from surge bag into the bioreactor.

Cell culture media and buffers can account for up to 25–30% of your therapy’s total COGS.

By shifting to powder-based, on-demand manufacturing, the Krakatoa K500 substantially lowers media- and buffer-related costs and shortens lead time, while also helping to make therapies become more accessible to patients.

Built for Modern Biomanufacturing Organizations

The Krakatoa K500 transforms media and buffers from a supply-chain and cost liability into an on-demand manufacturing capability. By decentralizing production and embedding automation, quality, and traceability at the point of use, the Krakatoa K500 enables faster timelines, lower risk, and greater operational efficiency.

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Reduce Labor and Variability

Automation replaces manual preparation, mixing, and documentation. With minimal hands-on time and standardized execution, the Krakatoa K500 reduces labor costs, variability, and the risk of costly batch deviations.

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Eliminate Supply Chain Bottlenecks

Powder-based pods reduce the number of consumables required and eliminate cold-chain transport and storage. On-demand production removes supplier lead times and reduces incoming QC, storage, and management.

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Streamline Quality Compliance

Integrated batch records, inline monitoring (pH, conductivity, turbidity), sterile filtration, and closed, single-use workflows reduce manual documentation and deviations. This helps control the downstream cost of quality compliance, enables traceability and confidence in batch quality, and provides immediate audit-ready documentation.

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Reduce Environmental Footprint

By eliminating cold-chain shipping and long-term refrigerated storage, the Krakatoa K500 significantly reduces energy consumption and emissions, supporting both sustainability goals and long-term cost efficiency.

The Power of the Pod

Krakatoa K500 single-use pod

Media and buffer formulations are prepackaged and delivered ready-to-use in standardized pods designed for flexibility and scale. Two pod sizes support any production volume from 35–100 liters or 175–500 liters. QR-code-driven execution enables seamless operation with full digital batch traceability, simplifying workflows while ensuring consistency and control.

Process development

Unlock Your Manufacturing Potential

Research and development

Custom Media and Buffer Development Services

Documents and Downloads

Take a closer look at our helpful product information to learn how our cell culture media products and services can support and accelerate your groundbreaking research.

Krakatoa® K500 Product Note

Review the technical details, features, and benefits of the Krakatoa K500 manufacturing system.

FAQs

Have a question? We’re here to help. If you don’t see your question, visit our FAQs page or contact us.

What is the Krakatoa® K500?
The Krakatoa K500 is a fully automated, free-standing media and buffer production system that yields up to 500 liters of sterile, ready-to-use solutions on demand using proprietary powder-based pods.

Krakatoa is manufactured by our sister company, Stoic Bio , and is distributed by Nucleus Biologics. Cell culture media and reagents for the Krakatoa media maker are manufactured by Nucleus Biologics.

What is the Krakatoa® K500 designed to produce?
The Krakatoa K500 is designed to manufacture sterile cell culture media and buffers at the point of use, supporting batch volumes up to 500 liters.
What production volumes does the Krakatoa® K500 support?

The Krakatoa K500 system supports batch sizes ranging from 35 to 500 liters, depending on process requirements.

How long does it take to produce media or buffers using the Krakatoa® K500?

Typical runs produce up to 500 liters in under three hours, with less than 15 minutes of hands-on setup time.

Is the Krakatoa® K500 suitable for GMP manufacturing?

Yes. The Krakatoa K500 is designed for use within validated GMP processes. It supports GMP manufacturing with closed, single-use workflows, integrated sterile filtration, real-time monitoring, and automated digital batch records. Nucleus Biologics provides a comprehensive validation package (e.g., IQ/OQ/PQ) to assist customers with process qualification; however, final GMP compliance and validation of the end product remain the responsibility of the user.

Is the Krakatoa® K500 a closed system?
Yes. The Krakatoa K500 uses a fully enclosed, single-use workflow designed to reduce contamination risk, operator exposure, and process variability.
Can I use my existing media or buffer formulations?
Many existing formulations can be adapted for use on the Krakatoa K500. Nucleus Biologics’ formulation services can help evaluate, optimize, and configure formulations for powder-based manufacturing.
How does the Krakatoa® K500 support documentation and traceability?
The Krakatoa K500 generates automated digital batch records and captures process data during each run to support traceability, review, and audit readiness.
Does the Krakatoa® K500 require a dedicated media prep room?
No. The Krakatoa K500 is designed for point-of-use operation, eliminating the need for centralized media prep rooms and associated infrastructure.
Once I start a pod run, do I need to be by the Krakatoa® K500 during production?
No. After initial setup and run initiation, the Krakatoa K500 operates automatically. Operators can monitor progress through the system interface while focusing on other tasks.
Does the Krakatoa® K500 require cleaning?
The Krakatoa K500 uses closed, single-use fluid paths, eliminating the need for cleaning and cleaning validation between runs.
How does the Krakatoa® K500 help reduce media and buffer costs?

Powder-filled, single-use pods and on-demand production reduces the number of consumables required, eliminates cold-chain transport, and significantly reduces incoming QC.

What type of warranty does the Krakatoa® K500 come with?
The Krakatoa K500 includes a standard manufacturer warranty.
How is the Krakatoa® K500 different from traditional media prep systems?
Traditional systems rely on fixed tanks and advance preparation. The Krakatoa K500 delivers automated, point-of-use media and buffer manufacturing at bioreactor scale, without the infrastructure or lead times.