Nucleus Biologics has launched the Krakatoa K500, a pod-based media and buffer manufacturing system for bioreactor-scale production. The system produces up to 500 litres of sterile solutions in under three hours with less than 15 minutes of hands-on time. The automated system uses preformulated powder-filled pods and a closed single-use workflow to eliminate cold-chain transport, refrigerated storage and centralised media preparation. It features QR-code-driven operation, continuous inline monitoring and automated digital batch record generation for GMP compliance. The San Diego-based company developed the product over six years to reduce costs and complexity in advanced therapy development. Founder David Sheehan said the system aims to create a new paradigm for delivering bioprocessing liquids to bioreactors whilst improving patient access through cost reduction.

Nucleus Biologics launches Krakatoa(R) K500: A pod-based, on-demand media and buffer manufacturing system transforming scale bioproduction. February 10, 2026 SDBN news, syndication comments off on Nucleus Biologics launches Krakatoa(R) K500: A pod-based, on-demand media and buffer manufacturing system transforming scale bioproduction. SAN DIEGO - (BUSINESS WIRE) - #bioprocess - Nucleus Biologics launched the Krakatoa(R) K500, a pod-based, on-demand manufacturing system that produces 35 - 500L of media and buffers at point of use. Click here to view original post

SAN DIEGO, Jan. 9, 2025 /PRNewswire/ - Nucleus Biologics, a leader in precision cell culture media development, is proud to announce that it has achieved an industry-leading quality milestone. It has received EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification from SGS. This Excipient GMP certification will better support the cell culture media, buffers, reagents, and supplements needs for our cell and gene therapy customers. This certification, in addition to our ISO 13485 certification, underscores Nucleus Biologics' commitment to delivering the highest quality products that meet the most stringent safety, consistency, and compliance requirements of the biopharmaceutical industry.EXCiPACT is an internationally recognized certification standard specifically designed for excipient manufacturers. It ensures that facilities adhere to the highest standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)