The Commercial Manufacturing Checklist for Cell Therapy Developers
To determine whether your patient-specific cell therapy product is ready for commercially viable manufacturing, our team has put together a checklist of items meant to provide you with a rough idea of where your process stands and your commercial readiness.
A Place for NK Cells in the Journey Towards the Next Generation of Adoptive Immunotherapies
In this brief overview, our experts discuss several ways in which Natural Killer (NK) cells can offer us a path forward as a deliver platform for engineered cell (and ex vivo gene) therapy. Here, we focus on four different aspects of cytotoxic cell therapy and provide some contrasts where we feel NK cells can offer promise: Durability, Control, Manufacturing, and Toxicity.
Impact of Apheresis Collection Quality on Manufacturing of Cell Therapeutics
With cell therapy pipelines growing rapidly each year, the need for optimized apheresis collections, a critical first step in the manufacture of many cell therapy products, is evident. Highly variable or poor quality starting apheresis collections present a significant engineering and manufacturing development challenge.
The Cold Truth: Cryopreservation of Final Product in Cell Therapy Manufacturing
While using “fresh” final products in cell therapy manufacturing is perfectly acceptable for proof of concept of the cell therapy, as development into late-stage and then commercial production becomes the goal, different constraints arise. This is where cryopreservation of the final product becomes an option and, in some cases, even a necessity.
Minaris Regenerative Medicine is a global contract and manufacturing organization (CDMO) for cell and gene therapies. We offer our clients high value clinical and commercial manufacturing service, development solutions, and technologies. We are pioneers in the field with more than 20 years' experience providing outstanding quality and reliability.