Trailhead Biosystems has developed a platform of technologies and services that will make it a leader in the cell therapy field. We are a contract research organization that develops cell culture recipes, products and services for the cell therapy industry.
There are significant barriers in cell therapy including, but not limited to:
- How can cells be expanded and differentiated using animal-origin-free and non-serum components?
- How do these components effect the biology of the cells?
- What are the manufacturing tolerances for these components to achieve the same product?
- Are these recipes scalable?
- Will these methods be sufficient for FDA approval for potency and clinical release?
All of these questions can create impediments to rapid growth, and increase complexity, time and expenses.
One of our goals is to develop cost-effective industry-standard assays that will be used to qualify cell therapies for clinical studies, and, downstream, to qualify every batch for commercial therapeutic use. We work for cell therapy companies and academic labs who are entering clinical studies to develop cell culture media and recipes using our proprietary software systems and expert knowledge. For those academic researchers who don’t have a commercial outlet, we will serve as a ‘development house’ to partner with and create subsidiary companies under our umbrella.