If you’re a hematologist or oncologist and need to transplant cells in your patients to keep them alive, you may need a service for graft processing that your hospital can’t provide often. Of course, some hospitals have so-called “bone marrow processing lab”, with some devices that allow to deplete red blood cells and platelets. But what if you need to customize your graft or create a new one, playing with different cell populations in sterile clinical-grade conditions?
I’d like to overview some companies which provide service for cell therapy – cell processing and manufacturing. They are not selling cell products, but they are providing a service.
These companies can provide you with solutions to start up your business in regenerative medicine, develop your own unique cell product and bring it from bench to market.
All of the companies are USA-based and use a set of standards – GMP/GTP/GLP.
let’s look what kind of services you can get today:
Company provides number of services:
– cGMP manufacturing
– preclinical and clinical product development expertise
– cell product assay development (in vitro and in vivo tests and analysis of quality of the product)
– stem cell services – customized Production of: Human mesenchymal stem cells derived from adipose tissue, Human mesenchymal stromal / stem cells derived from bone marrow, Adipose-derived stem cells, bone marrow stromal cells, and fibroblast control cells from a variety of animal species
– commercialization of cell-based products consulting –
regulatory service and support (preparing IND according FDA requirements), process development (cost-effective solution for product development and clinical phase planning)
Besides contract manufacturing, consulting and stem cell banking and transport, Progenitor Cell Therapy has some unique cGTP services:
– Cryopreservation and storage
– CD34 cell selection
– T cell depletion
– Red blood cell depletion
– Plasma depletion
– Donor leukocyte preparation
– Umbilical cord blood processing
– Bone marrow & peripheral blood progenitor cell processing
– Flow cytometric analyses
– Polymerase Chain Reaction
– Microbial assays
– Blood typing
– Infectious disease testing
– Functional assays (colony assay, cytolitic T-cells, cytonike production)
Lonza works with Organ and Tissue Procurement Organizations, hospitals and private physicians in the U.S. to collect tissues within the framework of the AATB standards and FDA regulations for manufacturing processes for clinical use.
What type of cells have you worked with?
Fibroblasts, keratinocytes, renal cells, umbilical cord cells, vascular endothelial cells, dendritic cells, myoblasts and mesenchymal stem cells are among the cell types with which we’ve worked.
finally, one more company, provided GMP/GTP/GLP contract cell product manufacturing around US – AppTec
I hope this information will be useful for you and help to develop your cell therapy business or customize a graft for your patients.
picture credit: Lonza corp.