GMP Fresh Whole Bone Marrow
AllCells’ Clinical Grade Fresh Whole Bone Marrow is a rich source of adult stem cells such as CD34+ hematopoietic stem and progenitor cells. These cells are capable of differentiating into all of the mature blood cell types. Mesenchymal stromal/stem cells are also found in bone marrow and have been shown to have therapeutic potential in several cardiovascular, autoimmune, and immune-based diseases. A Certificate of Analysis (CoA) and a comprehensive summary of record documents are provided with every order. Clinical Grade Fresh Whole Bone Marrow is only available through consultation with an AllCells Made-to-Order representative.
- Diverse Donor Pool and Extensive Donor Screening
- High viability and stability leukopaks
- GMP qualification of SOPs and stringent quality systems
- Integrated Project Management approach to meet your specific criteria
AllCells can manufacture the following bone marrow products:
Whole – Whole bone marrow aspirate.
MNC – Mononuclear cells isolated from bone marrow aspirate.
(CUL) MSC – Cultured mesenchymal stem cells derived from adherent nucleated cells from the bone marrow.
(HSC) CD34+ PS – Isolated cells positive for CD34. Phenotypically characteristic hematopoietic stem cells. Isolation by magnetic microbead positive selection.
MNC | CD34 dep – Mononuclear cells that are depleted of CD34 positive cells.
Bone Marrow products are collected by qualified clinicians from the posterior iliac crest of a healthy donor. Aspirate (50mL) is drawn from each hip from a maximum of 2 sites using multiple syringes. The aspirate is filtered to remove clots, bone chips, spicules, and then pooled to normalize cell concentration between draws. Whole Tissue, CD34 Hematopoietic Stem and Progenitor Cells (HSPCs), Mononuclear Cells (PBMCs), Mesenchymal Stromal Cells
*Cell type, cell selection method, and unit size (by volume or cell count) vary depending on format.
BMMC
Bone Marrow Made-to-order
AllCells' on-site GMP collection facility and GMP cleanroom enables us to offer the highest quality, made-to-order (MTO) custom products that will meet your specific needs – from specific donor attributes to cell isolation methods. The AllCells GMP team will partner with you, bringing project management expertise to define, design and deliver your donor program and product, all with regulatory oversight and following FDA guidelines.
We provide custom services at every level:
- Donor Management Services
- Cell Processing and Product Development
- Research-specific Isolation Protocols & Technology Transfers
GMP Bone Marrow Products are a rich source of CD34+ cells, Mesenchymal Stem Cells (MSCs) and other leukocytes. Our products are quality controlled for cell count and viability using a validated AO/PI protocol and pass a Sterility Test in accordance with USP71 guidelines using compendial testing.
- Anti-coagulant: Heparin
- Volume: 100mL
- Viability: NLT 90%
- TNC Concentration (x106 cells/mL): NLT 8
- Sterility Test (USP71): No Growth
At AllCells, we believe that your success is our success. We believe that sharing our knowledge and expertise is more than a business practice, it’s a responsibility. And we believe that collaboration leads to better outcomes. Below is a collection of relevant links to Bone Marrow resouces including blog posts, webinars and useful protocols to help you become more efficient and more effective. Have technical questions about Bone Marrow products? Our Customer Success Team is standing by.
WEBINARS
BLOG POSTS
- Navigating the complex world of regulations: How AllCells is changing cell therapy and protecting against product-ending events
- The Key to Developing Good Manufacturing Practice (GMP) Biomaterials for Cell and Gene Therapy Development
- The Therapeutic Potential of HSC-based Gene Therapies
- Why You Should Start Clinical Grade Cell Supply Discussions Early in Cell and Gene Therapy Development
- What You Need to Know About Regenerative Medicine in 2022: Industry and Tech Trends
- A Donor-Centric Approach to Cell and Gene Therapy