What is an Organofab?

An Industry-Enabling Framework

An Organofab™ is a comprehensive system for manufacturing living human organs, tissues, and cellular products. The hardware consists of a hermetic, modular environment with robust automation that interconnects different types of state-of-the-art manufacturing equipment. This equipment can include both industry-standard tooling, as well as a customer’s newly developed (or still-developing) tools. The system’s software includes not only user interfaces and controls but also an integration to medical imaging data that allows for patient-specific medical innovations and treatments, and a record-keeping and compliance management platform.

A Point-of-Care Solution for Tissue and Cell Manufacturing

We are bringing the Organofab to the world at a time when bio-manufacturing materials, equipment, science, and use-cases are experiencing a period of rapid technological advancement, and hospitals around the world are beginning to implement Point-of-Care manufacturing programs.

The Organofab's scaleable design allows a fully-functional unit to fit the needs and form-factor of a desired hospital application inside the hospital itself, rather than in a separated lab. Hermeticity/sterility, automation, and modular aspects of the Organofab design allow a hospital to integrate different industry-standard bio-manufacturing equipment, to deliver a medical product directly into the operating room, or wherever it's needed. Its customizable interface will meet all the needs of the space it is housed within.

Comprehensive software behind the Organofab system analyzes and adapts patient scans and data into models that match each individual's existing anatomy, to be produced with patient-specific cells for seamless implantation. The platform also provides all the tracking, analysis, and record keeping tools required to stay compliant with the FDA, cGMP, ISO, and others.

The Organofab provides a platform in which all of these future-trends can come together within a single safe, robust, and highly flexible system.

An Evolvable, Serviceable Solution for R&D

The Organofab provides an integrated, customizable, plug and play environment for iterative bio-engineering R&D.

An Organofab environment can be used to produce the substrate surfaces, growth medium, and the tooling components that are in intimate contact with tissues. Peripheral access to tools in the system provides significant benefits regarding the ability to add, service, or change any tools as needed. The Organofab's "cleanspace" and "toolPod®" technologies allow for easy installation/removal of tools, without disrupting the hermeticity and active work-flow of the system or other currently-installed tools. Various internet connected controls, sensors, and tooling/equipment feedback systems are inherently designed into an Organofab. Visual sensors such as cameras and microscopes provide real-time monitoring functions as well as remote management capabilities. The storage of this data can be critically important to understanding effectiveness of processing strategies and tissue engineering outcomes.

The Organofab's toolPod can be customized to fit all the needs of a developing bio-engineering application. Tools are removed or inserted through an intuitive chassis interface that accepts the tool and then loads it into the Organofab, connecting it to the cleanspace and any feedstocks/consumables. The toolPod's interface to an existing or developing tool it houses (as well as the Organofab's interface as a whole), is fully scalable and customizable, to meet the still-developing and ever-changing needs of R&D in this industry.

The Organofab provides a robust framework for development, ready to enable the realization of novel, game-changing bio-engineering technologies.