GMPrime™ Bone Marrow Aspirate

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Source:

Bone Marrow

Status:

Healthy

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100 mL BM008F-GMP
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Description

Product Overview:

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.

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Storage Conditions:

Use bone marrow aspirate immediately upon receipt.

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

Figure 1. Representative bone marrow aspirate samples were assessed for white blood cell (WBC) yield and viability. As with other raw materials, yield (teal bars) was variable and ranged from a max of 3.29E+09 to a min of 1.38E+09 (avg. 2.39E+09). Viability (blue line) was relatively consistent throughout all samples assessed ranging from a max of 96.21% to a min of 93.37%. (avg. 94.94%).

Figure 2. Representative bone marrow aspirate samples were assessed for CD34+ hematopoietic stem cell (HSC) yield and viability. As anticipated,  CD34+ HSC yield (teal bars) was variable within this sampling and ranged from a max of 4.60E+07 cells to a min of 1.30E+07 million cells (avg. 3.15E+07). Viability (blue line) remained high throughout all samples assessed and ranged from a max of 98.32% to a min of 93.31% (avg. 95.77%).

Certificate of Analysis is customized to meet the specific requirements of the customer.