FAQ
Partner with the Leader in Quality Products
for Regenerative Medicine.
PRODUCT INFORMATION
Celle provides the following cryopreserved biologic/tissue-derived products for provider use:
• CD34+ Cell Isolates
• Other Cell Isolates as requested
• Fresh and Cryopreserved Cord Blood (both research and clinical grade)
Our fresh and cryopreserved cord blood products are available for approved clinical uses and clinical trials.
CELLE provides researchers with reliable, extensively characterized cell isolates, manufactured under cGMP conditions to ensure consistency and full traceability.
COMPLIANCE, ACCREDITATION, AND SAFETY
Our donor and sourcing protocols are designed for maximum safety and ethical compliance:
• Donated cell sources are procured under an IRB-approved protocol and consent process.
• Each donor is screened via a detailed medical history and undergoes a full panel of infectious disease testing.
Yes. We are cGMP/cGTP compliant. Our facility is FDA-registered, and we manufacture PHS361 products (autologous/family use), PHS351 products (allogeneic/unrelated use), and an FDA 510k-cleared reagent used in cord blood processing. Documentation confirming our FDA registration and tissue establishment status is provided to all qualified practices.
Our products are manufactured at Cryo-Cell International, a facility that is accredited by both the Foundation for the Accreditation of Cellular Therapy (FACT) and the Association for the Advancement of Blood & Biotherapies (AABB). These accreditations represent the gold standard for excellence in cellular therapy.
Quality is verified through extensive testing and documentation:
• Viability Analysis: We test viability on a lot-to-lot basis and provide a post-thaw viability analysis report for your review before shipment. Our historic post-thaw viabilities are greater than 90%.
• Sterility: We test sterility on a lot-to-lot basis and provide an analysis report for your review before shipment.
• Certificate of Analysis (COA): Every vial is accompanied by a COA with the product characteristics.
ORDERING & HANDLING
Once your account is established, you can place orders by contacting your dedicated account representative via phone or email.
Depending on the product, our products can be shipped via LN2 vapor shipper, dry ice, or wet ice as required. All cryopreserved shipments are sent in a validated shipper and accompanied by a data logger to record temperatures during transit. We will provide all storage and handling requirements upon ordering.