GMPrime™ Bone Marrow Aspirate
Streamlining the Development of Cell and Gene Therapies With GMP-Compliant Bone Marrow Aspirate
Bone marrow is a rich source of stem and progenitor cells, including hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC). HSCs and MSCs are capable of differentiation into a number of different cell types, therefore they are a major area of investigation in regenerative medicine for the treatment of a diverse group of diseases.
The process of bringing a cell therapy to clinical adoption can be daunting due to the stringent requirements imposed by regulating agencies. In order to meet the regulatory guidelines for safety and efficacy validation for clinical trial and commercial use, all cell therapies ultimately need to transition to GMP-compliant starting materials for their product development process. Trust HemaCare to provide you with the top-quality, GMP cells and regulatory documentation required to navigate the complex path from benchtop to commercialization.
Seamlessly Transition Your Discovery From Research to Commercialization
GMP-compliance adds an extensive level of quality review and documentation that serves to standardize raw materials and processes, eliminating most external sources of variability with the exception of those associated with the donor. The transition to GMP-compliant materials is a necessary step in the development of cell therapies to satisfy regulatory guidelines and ensure the safety of recipients of these therapies. The success of cellular therapeutics will greatly benefit from the early adoption of stringent quality management systems and consistent, high-quality materials.
Our GMPrime bone marrow aspirate, and its research use only (RUO) counterpart HemaPrime™ bone marrow aspirate, are collected following consistent collection procedures and processes. Thus, partnering with HemaCare for RUO and GMP-compliant raw materials during the early stages of development can simplify and streamline your journey to commercialization.
High-Quality, Consistent Cells
Figure 1. Representative bone marrow aspirate samples were assessed for white blood cell (WBC) yield and viability. As with other raw materials, WBC yield (teal bars) was variable and ranged from a max of 3.29E+09 to a min of 1.38E+09. Viability (blue line) was relatively consistent throughout all samples ranging from a max of 96.21% to a min of 93.37%.
|Mean||2.39 x 109||94.94%|
|Median||2.45 x 109||95.08%|
|+/- SD||7.20 x 108||1.24 %|
Chart 1. Statistical analysis of samples reveals an average WBC yield of 2.39E+09. As previously highlighted, high viability was observed with all samples and averaged 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 (1.52% of WBCs) to a min of 1.30E+07 cells (0.90% of WBCs). Viability (blue line) remained high from a max of 98.32% to a min of 93.31%.
|Mean||3.15 x 107||95.77%|
|Median||3.35 x 107||95.73%|
|+/- SD||1.23 x 107||2.17%|
Chart 2. Statistical analysis of samples reveals an average CD34+ cell yield of 3.15E+07. As previously highlighted, high viability was observed with all samples and averaged 95.77%.
Starting material quality and consistency have a direct impact on the quality and efficacy of the final therapeutic product. Furthermore, the quality and consistency of starting material relies heavily on the technical expertise of the staff performing the procedure.
Bone marrow aspiration, in particular, requires a sharp eye and strong technical knowledge. With over 20 years of experience, our staff expertly performs bone marrow aspiration to maximize collection of desired cellular components.
The bone marrow aspiration is performed at HemaCare’s FDA-registered collection center by our qualified clinicians from IRB-consented healthy human donors. The aspirate is drawn from the posterior iliac crest (top ridge of the back of a hip bone) using a syringe attached to the needle containing anticoagulant.
Rigorous operational controls and standardized processes ensure customers receive reproducible and consistent high-quality starting material, eliminating variability.