• NB-Lux™ AI connects formulation through GMP manufacturing in a single AI-enabled ecosystem, accelerating timelines and improving transparency from R&D through Excipient GMP.
• Built off NB-Lux™, the industry’s first digital platform for media and buffer pricing and ordering, NB-Lux™ AI enables delivery of custom solutions in 4-6 weeks.

Nucleus Biologics, a leading provider of custom cell culture solutions and manufacturing technologies for advanced therapies, today announced the launch of NB-Lux™ AI, a next-generation digital ecosystem designed to streamline media and buffer manufacturing and management.

NB-Lux™, launched in 2020, was the first cloud-based ordering portal. NB-Lux™ AI builds upon that foundation, evolving into a fully integrated, AI-enabled ecosystem that eliminates manual processes and fragmented systems. This new system connects formulation design, feasibility analysis, quoting, ordering, approvals, manufacturing, and documentation into a single continuous workflow.

“Imagine an Amazon-like user experience for ordering and tracking your critical media and buffers,” said David Sheehan, Founder, President, and CEO at Nucleus Biologics. “With NB-Lux™ AI, we’ve embedded intelligence and automation across the entire process, enabling our therapy developer colleagues to receive GMP media in 4 weeks and have access to a document repository of all their lots and documents for regulatory filings.”

A Fully Digital, End-to-End Workflow

NB-Lux™ AI introduces advanced capabilities that reduce manual steps and enable faster decision-making and therapeutic development. New features include:

• Formulation upload
• AI-driven feasibility analysis (solubility, stability, hazardous material assessment, predicted specifications)
• Automated quoting and specification generation
• Integrated PO upload and eSignature workflow for specification approval
• Real-time order tracking and project status visibility
• Automated BOM generation and inventory depletion
• Digital batch record initiation
• The “Vault” (secure centralized document repository) for COAs, formulations, specifications, order history, and regulatory documentation

By digitizing the entire process, from formula to GMP release, NB-Lux™ AI enables:

• Faster development timelines (4-6 weeks GMP TAT)
• Reduced operational risk and human error
• Simplified regulatory filings with single source of documents
• Seamless scale from R&D to Excipient GMP manufacturing
• Direct integration with Krakatoa® manufacturing systems

Redefining Media and Buffer Sourcing

NB-Lux™ AI represents a fundamental shift in how the industry approaches media and buffer manufacturing and management, transforming a traditionally manual, fragmented process into a fully digital, connected ecosystem. With NB-Lux™ AI, developers can:

• Order media and buffer solutions
• Easily customize formulations, packaging, and quality requirements
• Maintain complete ownership and visibility of their media and buffer formulation
• Seamlessly scale up from R&D to Excipient GMP manufacturing
• Instant access to all order details and product-related documentation

“NB-Lux™ AI is the digital backbone for modern media and buffer manufacturing,” added David Sheehan. “With today’s large language models, any scientist can get a formulation for any cell type with specific CQA’s. The next hurdle to solve is rapid GMP manufacturing. NB-Lux™ AI gets you to the clinic faster.”

For more information about NB-Lux™ AI, visit nucleusbiologics.com/nb-lux

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.

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“NB-Lux™ AI is the digital backbone for modern media and buffer manufacturing."