Cascia’s stem cell therapeutics were engineered to overcome the two main barriers to adoption by the medical community:

• Speed – stem cells are most effective when they can be administered to the patient within the first 24 hours following a major event such as stroke, heart attack, or severe trauma.  Many competing cell products rely on ex vivo expansion of cells, which must be accomplished in a clean room production facility, a process than typically takes at least two weeks.  This limits the usefulness of the therapies for many patients.
• Cost – Clean room production most often occurs at a remote pharmaceutical production facility, and the substantial costs associated with building and operating such facilities must be recovered in the price of the treatment.

Cascia was created to provide hospital-based stem cell treatments engineered to be available within a few hours, with production costs that are a fraction of the alternatives.  Our Vivolux system enables us to achieve this vision.

Integrated Solution

Vivolux is designed to link all production instrumentation, record keeping, quality control, procurement, financial, and other reporting systems.  This ensures that every batch of cells is monitored from the moment of bone marrow aspiration to the final implantation into the patient, while providing a level of quality control and traceability comparable to that of a typical pharmaceutical plant as each step is recorded by both instrumentation and video.  The batch records, information about materials on hand, status reports from instrumentation provided with IoT (Internet of things) features, and video can all be accessed remotely for continual quality review.

Production of stem cell therapeutics is a complex process that is extremely difficult for humans to accomplish without significant time and cost.  Integrating readily available information systems and features incorporated in modern instrumentation allow us to managed complexity, maintain control of the process, and produce high quality therapeutics so that our medical scientists can focus their efforts on delivering the best treatment for our patients.

Technology Driven

Cascia's approach to automation relies on major software platforms such as Microsoft Dynamics and laboratory information systems from instrument providers such as ThermoFisher.  This drastically reduces development time and expense, and allows our scientists and information technology professionals to focus on value-added tasks rather than recreating simple process flows that are available in commercial software.  By building on Microsoft platforms that are available in more than 40 languages, any technology we develop is ready to implement in any market, and every application is already integrated with the business analysis tools in the Microsoft suite of software.

Use of standard interfaces also lets our platform interact with systems of the hospital and other commercial partners.  Our bioprinting robot can import spatial information from diagnostic imaging tools such as MRI and CT scanners, convert that information to .SLT files, and use the resulting information to design custom implants.

Our photomodulation options can be used to cure photosensitive materials and, in some cases, hydrogels containing selected components can be exposed to a variety of wavelengths that will determine the amount of cross-linking which in turn affects the tensile strength and degradation rate of the implant.  Using a femtosecond pulsed Nd-YAG laser to drive an optical parametric oscillator, the laser can output light from 200 nM (the far UV‑C range) to 2,500 nM (the mid IR‑B range), all of which can be programmed and controlled from the bioprinting station.

Various components of Vivolux provide reactive artificial intelligence capabilities, these include:

• An expert system to customize formulations based on each patient’s laboratory values, clinical status, and desired outcome ›
• DNA testing to identify specific genes and relevant biologic pathways
• Image recognition of cell products for improved quality control and to identify rare phenotypes
• Biometrics and voice recognition to enable use of computer tools by our medical scientists in surgery without compromising sterility
• Robotics to prepare implants impregnated with stem cells
• Phototuning of light-sensitive materials
• Diagnostic imaging from MRI/CT scans to design custom sized implants

The batch records accumulated from each procedure form a data warehouse that can be used to train even more capable AI components in the future as these technologies continue to develop.