OH-Alive Innovator Platform: A Process and Manufacturing Platform for Cell Therapy
Cellular Therapy has evolved greatly over the past decade. It has shown immense promise as a therapeutic for a number of diseases. With enormous needs for derivation of pure and mature human cells of various types and multiple significant entry barriers to cell-therapy, OH-Alive was formed to offer solutions to investigators at the pre-clinical phase through early stage clinical trials.
OH-Alive is a one-stop Stem Cell Innovator Platform that will enable for-profit entities, clinicians and academic researchers to better understand cell-culture protocols so that when they advance their cutting-edge therapies from the bench to the bedside they can report to the FDA their manufacturing tolerances and sound scientific rationale for the methods they use in preparing their cell products.
Our goals are:
- To transform medical therapy through the use of cells rather than drugs to heal tissues and organs.
- To create the commercial and academic infrastructure in Ohio to establish a self-sufficient, vibrant biotechnology industry and support services that will attract cell-therapy-institutions across the US.
OH-Alive merges developmental biology and stem cell biology with cutting-edge, hardware instrument technology, and computerized experimental design and analysis to perform process-specific parameter optimization for customers seeking to develop cell therapies. Implementing Quality by Design (QbD) principles, cell-culture optimization uses Design of Experiment (DoE) theory combined with Multivariate Data Analysis (MVDA) allowing OH-Alive to:
- Generate mathematical models of the biological system
- Understand the effector-response relationship in cell-culture
- Provide a systems biology analysis of the differentiation space
Through the Case Western Reserve University Technology Transfer Office, OH-Alive has dedicated support for managing and protecting new intellectual property (IP). OH-Alive's clients will receive the exclusive ability to benefit from commercialization outcomes emanating from utilization of the facility. Also, OH-Alive will assign ownership of any/all IP that is created as part of its fee-based service to its clients. Collaborative agreements to reduce fee-for-service costs will be negotiated on a case-by-case basis but royalty stream or milestone payments will be added to this co-development situation.
Customers will also get access to NCRM's existing competency in executing new cell therapies. OH-Alive staff will collaborate on grant applications, especially SBIR/STTR mechanisms. Together this will lead to the commercialization of new cell therapies, resulting in the creation of new IP for cell-culture manufacturing and innovative cell-based treatments for diseases.