[HemaCare] GMPrime™ Bone Marrow Aspirate

[HemaCare] GMPrime™ Bone Marrow Aspirate

 

:

Bone Marrow

Healthy

Storage Conditions:

Use bone marrow aspirate immediately upon receipt.

 

Testing: Donors are tested for HBV, HCV, HIV, HTLV, WNV, Trypanosoma cruzi, and Syphilis.

 

Bone marrow is a rich source of stem and progenitor cells. Under appropriate growth conditions and stimuli, hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC) are capable of differentiation into a number of specialized cellular subsets. Due to the pluripotent nature of these cell types, there is a great deal of promise for development of treatments for an array of debilitating and difficult to treat diseases and thus are a major area of investigation and clinical development.

Bone marrow aspiration is performed at HemaCare’s FDA-registered collection center by our qualified clinicians from IRB-consented healthy human donors. Bone marrow aspirate is drawn from the posterior iliac crest (top ridge of the back of a hipbone).

HemaCare’s GMP-compliant qualification requires implementation of SOPs and formal quality systems that result in reduced variability and risk. Specifically, our GMP-compliant products require comprehensive employee training, competency assessments, and documentation of training as well as stringent material traceability and equipment logs. Additional quality performance testing and monitoring of quality indicators ensure industry-leading quality and stability. Each GMPrime bone marrow aspirate is subjected to an extensive quality review and is provided with supporting documentation during batch release.