Assureimmune LLC

AssureImmune is a leading biotechnology company specializing in comprehensive cellular therapy solutions, ranging from early concept development to product launch. Comprised of a dedicated team of scientists, technicians, and account managers, the company leverages decades of expertise in the cellular therapy industry, particularly in cord blood and adult stem cell banking. Their core mission is to partner with clients to navigate complex federal rules and regulations, ultimately aiming to improve patient outcomes and quality of life.

The company offers a comprehensive suite of services including storage solutions for cord blood and adult stem cells, and a variety of service solutions. These encompass peripheral blood mononuclear cell (PBMC) isolation, regulatory affairs consulting for IND/IRB submissions, quality assurance, cGMP facility design consulting, and clinical trial monitoring (CRO). AssureImmune provides end-to-end project management and contract manufacturing for clinical and pre-clinical projects, ensuring compliance with cGMP, GTP, and GLP guidelines.

Beyond services, AssureImmune also provides high-quality research-grade and clinical-grade cell and tissue products. Their product portfolio includes human bone marrow, whole blood, PBMCs, BMMNC, frozen cord blood, various types of mesenchymal stem cells (BM-MSCs, Umbilical Cord MSCs, Adipose MSCs), and human amniotic fluid. All clinical-grade products adhere to stringent government regulations, including FDA-approved INDs, IRB protocols, and comprehensive quality assurance programs, reflecting their commitment to strict HIPAA and CFR 1271 compliance.