APPLICATION OF CELLTOOL
On-Site Quality Control
ON-SITE QUALITY CONTROL
Efficient on-site quality control of cell-based products
In this century, development of Advanced Therapy Medicinal Products (ATMP), including gene therapeutics and human cell therapeutics, has been envisioned as ‘the’ beneficial breakthrough, capable of significantly advancing human health in the near future. This innovative medical approach bears the potential of curing a braod spetrum of human diseases, ranging from cancer to heart disease and immunological disorders.
Cell therapy manufacturing processes comprise consistent procedures of culture, expansion, genetic manipulation, stimulation, and in case of treatments of multiple patients, cell banking. Therefore, manufacturing procedures as well as analytics of human cell therapeutics need to be adapted to this broad range of complex manufacturing processes ensuring adequate safety, purity and potency of the final products.
You are looking for a method to monitor each step of production and to control quality of your cell-based products, but ...
you can‘t get the right antibody?
you don‘t want to loose too much valuable material?
you want to reduce quality assurance costs?
you need immediate results for your decisions?
BioRam® is an all-in-one device that allows reliable screening of each step during production and efficient validation of the completed cell-based products.
Raman spectra provide even more detailed information about intermediates and finalized therapeutics as compared to antibody dependent FACS analysis or immune fluorescence. For quality survey with BioRam® no labels or antibodies are required and only a few 100 cells are sufficient. Taken altogether BioRam® warrants fast amortization.
BioRam® saves time and money with each quality assurance measurement!
1. BioRam® saves costs and shortens hospitalization:
a: Quality assurance of autologous skin grafts
b: Survey of successful transfection with anti VEGF-vector to treat exudative macula degenerata (wet-form)
2. BioRam® saves life and money:
a: Quality control of blood products prior to transplantation
b: “Fitness” test of frozen cells after thawing
3. Raman Spectroscopy:
A noninvasive analysis tool for the discrimination of human skin cells
4. Raman spectroscopy as a tool for quality and sterility analysis for tissue engineering applications like cartilage transplants
For further information, please contact CellTool Customer Service.
1. BioRam® saves costs and shortens hospitalization.
No labeling with markers, colors, antibodies or beads needed
No modification of cell surfaces or activity state
No physical stress through shear forces or non-physiological conditions
No destruction of biological material