South Texas Blood & Tissue provides a wide range of research grade and cGMP starting materials for further manufacture into Advanced Therapies.
The organization has experience in providing customized solutions for donor qualification (demographics, infectious disease testing, medical social history), collection procedures, documentation, and post-collection processing in accordance with 21 CFR 1271.
Services and collections can be customized to meet the unique project needs of therapeutic developers.
cGMP starting materials for further manufacturing and research are collected in accordance with 21 CFR 1271 at South Texas Blood & Tissue collection facilities. All living donors are collected under IRB-approved protocols and research informed consent. Donor screening is compliant with FDA and international regulatory requirements.
The organization has the capability to meet the unique project needs of therapeutic developer clients by providing a dedicated program manager, licensed healthcare professionals, customized donor qualification and research protocols, access to our large, research donor registry and our ISO 9001:2015 compliant integrated global quality management system. The team also provides global logistical support.
Leukopaks | Mononuclear Cells (PBMCs/MNCs) |
|---|---|
Birth Tissue | Umbilical Cord and Placenta |
Umbilical Cord Blood | Fresh and Cryopreserved, with Specified Volumes and Cell Counts |
Blood Products | Whole Blood, Blood Components, Buffy Coats and Isolated PBMCs |
Deceased Donor Tissue | Musculoskeletal, Bone, Skin, Vascular Tissue, Adipose |
