Our technology for manufacturing MSC-based medicinal products for veterinary use utilises the therapeutic potential of safe allografts (one donor – many recipients).
This approach allows the pharmaceutical to be batch-produced, without the need to collect the patient’s biological material each time. This is in contrast to treatments based on autologous transplants, wherein the MSCs are administered back to the patient after isolation and necessary processing.
Allogeneic cells can be made available off the shelf at the veterinary clinic, which increases treatment comfort and simplifies the procedure.
Proper donor qualification is the critical step in producing biopharmaceuticals based on allogeneic stem cells, as it eliminates the risk of infectious agent transmission. At Bioceltix, the starting material used for the production of the batch is subjected to rigorous quality control testing in certified analytical laboratories, accredited by the Polish Centre for Accreditation. We want ensure the safety of our medicines – that is why our quality control panel is established in accordance with the guidelines of the European Medicines Agency.
|TECHNOLOGICAL ADVANTAGE||CLINICAL ADVANTAGE|
|One donor – many recipients||
Greater treatment comfort for patients, owners and physicians
No age limits
|Purification through in vitro culture||Safe allografts with no risk of rejection|
|Cryopreservation of the finished product||Extended validity period, off-the-shelf availability|
|Batch production and process repeatability||Product quality and safety|
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