CTS STEMPRO HSC EXPANSION MED KIT，A4222301，Applied Biosystems

CTS StemPro HSC Expansion Medium was designed to help meet regulatory compliance requirements for ancillary materials and provides more functional cells for cell therapy applications. This xeno-free, serum-free medium is manufactured in accordance with cGMP for medical devices (ISO13485 guidelines). The phenotypes of the hematopoietic stem cells (HSCs) targeted for expansion are the total CD34+ cell population with an emphasis on enrichment of the CD34+CD90+CD45RA- cell subset. CTS StemPro HSC Expansion Medium can be used to study hematopoietic cells from human mobilized peripheral blood, bone marrow, or cord blood.

CTS StemPro HSC Expansion Medium consists of a liquid basal medium and a frozen supplement that is added to the basal medium at the time of use. Growth factors or cytokines are not included.

Features of CTS StemPro Expansion Medium include:
• Manufactured following cGMP for medical devices and designed to help meet regulatory requirements for ancillary materials used in cell and gene therapy manufacturing
• Superior expansion of total CD34+ cell population and enrichment of CD34+CD90+CD45RA- subset
• Maintenance of in vivo functionality as demonstrated in animal engraftment models

Designed to help meet regulatory requirements
CTS StemPro HSC Expansion Medium is manufactured in accordance with cGMP for medical devices and supported by a drug master file (DMF) and regulatory support file (RSF) to assist in global regulatory filings and approvals. The formulation is serum-free and xeno-free, and USP/EP grade components are preferentially chosen where possible. In addition, each lot undergoes quality control testing to ensure safety and performance for cell and gene therapy applications.

Superior expansion
CD34+ cells and the CD34+CD90+CD45RA- subset are found in low proportions in mobilized peripheral blood, bone marrow, and cord blood. They are important for proper hematopoietic and immune function and are studied in a variety of research areas, including transplantation biology, stem cell biology, and hematopoietic development. CTS StemPro HSC Expansion Medium enables superior expansion of not only the total CD34+ compartment, but also enriches for CD34+CD90+CD45RA- stem cells, providing more cells to work with (see figures below).

Maintenance of functionality
Functionality of expanded HSCs is critical to success in cell and gene therapy applications. The most widely accepted method for functional testing of HSCs is engraftment in mouse models. The theory is that if human cells persist after transplantation into immunodeficient mice, the cells have demonstrated long term repopulation and differentiation capacity, which are both defining factors of stem cells. See the figure below for representative mouse model engraftment data of CD34+ cells expanded in CTS StemPro HSC Expansion Medium.