INNOVATIVE PROCESSING AND DESIGN
Medical technology is always evolving. And we are always one step ahead.
For over 40 years, hematopoietic stem cells from bone marrow have provided stem cell transplant options to facilitate treatment for leukemia and other blood disorders. More recently, peripheral blood has provided a less invasive source of stem cells. In 1988, the first transplant of stem cells from umbilical cord blood was used to successfully treat a child with Fanconi’s anemia, presenting yet another stem cell therapy option. Continued clinical research and advances in cord blood banking have now moved cord blood stem cells to the forefront of treatment for both pediatric and adult patients. We are committed to advancing technologies for this field.
Bag Sets for Cryopreservation of Blood and Cellular Components
Pall is a key supplier to the rapidly developing cord blood banking industry. Pall’s cord blood collection, processing and transplant bag sets have become the industry standard backed by standard operating procedures and clinical outcomes from the NIH COBLT study. Our complete product family encompasses each step in the collection, processing, freezing and transfusion process for cord blood stem cells ensuring a safe, reliable and robust process.
- Cord Blood Collection, Processing and Cryopreservation Bag Sets are recognized as the industry standard backed by the COBLT Standard Operating Procedures (SOP).1, 2
- Transfer/Freezing Bag Set is designed for processing and freezing cord blood stem cells by the method developed at the New York Blood Center.1, 2
- Freezing Bag is compatible with the AABB Standard requiring integrally attached segments to be cryopreserved with the product.
- Freezing Bag is cited as an example of an acceptable storage container for the cryopreservation of cord blood units in the April 2005 Report on Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program, from the Institute of Medicine.3
- Collection Bag Set and Cord Blood Sterile Collection Bag (791-08) are FDA NDA approved. Transfer/ Freezing Bag Set, Cell Wash/Infusion Bag Set, and Freezing Bag are FDA 510(k) market cleared. All products are CE marked.
Advanced Bag Designs Meet Rigorous Industry Standards
Cord blood stem cells have been effectively used in the treatment of more than 70 malignant and non-malignant diseases, including sickle cell, leukemia, non-Hodgkin’s lymphoma, other forms of cancer, life-threatening anemias, and autoimmune diseases. As a key supplier to the cord blood banking industry, Pall provides a full range of bag sets that are used to prepare the cord blood stem cells for treatment.
Pall’s collection and processing sets are manufactured to cGMP using validated manufacturing processes that ensure safe, consistent and reliable product performance. Each bag is 100% inspected prior to release and is fully traceable by lot number.
Pall’s cord blood bag sets are uniquely designed to facilitate closed system processing of cord blood stem cells by the volume reduction method developed at the New York Blood Center.1 Volume reduction maximizes limited storage space while closed system processing minimizes sample loss and reduces the risk of contamination during handling. This method results in a high-quality sample available for transplantation.
Assessment of stem cell content and viability after long-term storage is a critical step prior to a successful transplantation. International standards recommend storing a cell sample attached to a unit of cord blood for quality control testing. Pall’s freezing bag includes sufficient tubing for the preparation of segments, enabling a sample aliquot to be cryopreserved with the final product. Using a tube segment for quality control testing prior to transplantation reduces the risk of contamination during the thawing process and provides critical information needed to predict treatment success.
For disease treatments or patient populations that require a higher cell dose to be transplanted, Pall’s advanced freezing bag design divides the sample into two compartments, facilitating transfusion of 80% of the stem cells while retaining 20% of the stem cells for ex vivo cell expansion. Scientific advances in our ability to amplify stem cells will greatly expand the applications for hematopoietic stem cells from cord blood.