Nucleus Biologics, a leading provider of custom cell culture solutions and manufacturing technologies for advanced therapies, 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.”