ALAMEDA, Calif.--(BUSINESS WIRE)--AllCells, LLC, (the “company”) today announced registration of its Alameda, CA facilities with the US-FDA enabling the company to immediately provide clinical grade products to customers developing cell therapies for regenerative medicine and immunotherapy. AllCells CliniCells™ Product Line features standard pack sizes of Clinical Grade Fresh Whole Bone Marrow. In the coming months, AllCells will offer standard pack sizes of Clinical Grade Fresh Leuko Pak products. Customization of these products will be possible depending upon the customer’s specific requirements such as donor profile, screening, qualification, and processing criteria.
AllCells CliniCells™ products are suitable for therapeutic applications and intended for further processing into allogeneic cell therapies. These clinical grade products serve as a rich source of adult human bone marrow stem cells such as CD34+ hematopoietic stem and progenitor cells (HSPCs) capable of differentiating into various mature blood cell types, and mesenchymal stem cells (MSCs) found in bone marrow which are capable of differentiating into different tissues such as cartilage, bone, or fat. Clinical Grade Fresh Leuko Pak products are highly enriched leukapheresis derived products which contain high concentrations of HSPCs, B cells, NK cells, Monocytes, and T-cells for possible immunotherapy applications.
According to ClinicalTrials.gov there are >33,000 cell therapy studies registered, including >3,600 studies involving MSC cell therapy, and >3,600 involving T-Cell therapy. The company’s President & CEO, Jay Tong, M.D. commented on the company’s introduction of clinical grade products: “AllCells’ made a major commitment of resources enabling regulatory compliance so the company could advance into this important emerging area of cell therapy product and services. I am proud and pleased AllCells’ is first to market for these breakthrough products and has been able to leverage its strengths in hematology and immunology in ways that can make a greater impact toward improving patient health. By providing a consistently high quality, readily available commercial source of stem cell-rich hematologic products that comply with US-FDA good tissue practice (GTP) regulations for cellular & tissue therapy, we will help customers accelerate their manufacturing scale-up efforts and development timelines. Moreover, we specialize in handling customized hematologic tissue procurement which is made possible through LeukoLab - a clinical division of AllCells, in cases where our customers have distinct tissue collection criteria deemed critical for bioprocess requirements and/or product efficacy.”
The company’s quality system complies with US-FDA 21 CFR 1271 regulations. Additionally, AllCells maintains Biologics and Tissue Bank licenses from California Dept. of Public Health. LeukoLab holds a clinical laboratory license. Human tissue collection protocols are approved by the company’s Medical Director and Independent Review Board (IRB) in accordance with federal law. AllCells is prepared to host customer qualification audits which can be arranged at the convenience of the customer.
AllCells will be premiering these new products at the upcoming International Society for Cellular Therapy Annual Meeting taking place May 25-28 in Singapore. The company will be sponsoring the Exhibitor Open House and Welcome Reception in addition to hosting a panel discussion on "STANDARDIZATION AND CATEGORIZATION OF STARTING MATERIAL FOR CELLULAR THERAPIES" featuring leading scientists. The ISCT Annual Meeting draws over 1,000 cellular therapy industry professionals, clinicians, and researchers from around the world.
AllCells maintains a sizeable database of human donors, and this repository is constantly increasing. For more information about the availability of clinical grade products, contact us at 1-888-535-3444, or 1-510-521-2600, and email@example.com.
About AllCells, LLC
AllCells is a biotechnology company dedicated to providing researchers and biomanufacturing organizations with high quality primary cells that enable drug discovery, preclinical development, and manufacturing of cell therapies. Leveraging its expertise in hematology and immunology cell isolations together with on-site hematologic tissue clinical collection operations, AllCells maintains a large repository of donor profiles that can be qualified for various biomedical applications. Freshly collected tissue is immediately processed in contiguous manufacturing facilities to produce purified cell types having unparalleled quality and consistency. Cells are shipped worldwide, or fresh cells can be immediately utilized in fee-for-service cell-based assays (“Bioservices”) custom designed according to customer criteria. For more information, please visit clinical.allcells.com.