Cord Blood Transfer/Freezing Bag Set

For processing and freezing 25 mL of cryopreserved, concentrated cord blood stem cells by the method developed at the New York Blood Center. ^{1, 2*} Each sterile set consists of two transfer bags and a two-compartment, three-dimensional 25 mL freezing bag joined by integral tubing and two connector lines (one spike and one luer).

• Two transfer bags, 200 and 150 mL. The 200 mL transfer bag concentrates primary stem cell-rich plasma while the 150 mL transfer bag receives the supernatant plasma from the concentrated stem cells. ^{1, 2**}
• Freezing bag is compatible with liquid nitrogen (LN2) storage. The three-dimensional bag design ensures a homogenous, controlled freezing rate for maximum cell viability.
• Freezing bag is uniquely compatible with the use of DMSO/Dextran and liquid nitrogen storage in ThermoGenesis Corporation’s BioArchive* System.
• Freezing bag’s two separable compartments allow for a 4:1 division of contents, allowing a consistent volume aliquot for ex vivo cell expansion. 
• Freezing bag is compliant with AABB Standard for integral segments cryopreserved with product, enabling confirmatory testing prior to transfusion.
• Addition of cryopreservative solution can be accomplished by either gravity feed or syringe pump.

1. 1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.; Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.
2. Fraser, J.K.; Cairo, M.S.; Wagner, E.L.; McCurdy, P.R.; Baxter-Lowe, L.A.; Carter, S.L.; Kernan, N.A.; Lill, M.C.; Slone, V.; Wagner, J.E.; Wallas, C.H.; Kurtzberg, J. Cord Blood Transplantation Study (COBLT): Cord Blood Bank Standard Operating Procedures. Journal of Hematotherapy. 1998, 7(6):521-61.

*BioArchive is a registered trademark of ThermoGenesis Corporation.

**SOP available at the EMMES website: http://spitfire.emmes.com/study/cord/

Application

For processing and freezing 25 mL of cryopreserved, concentrated cord blood stem cells by the volume reduction method developed at the New York Blood Center. 

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 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. SOP’s referencing Pall bag sets are available at the EMMES website: https://web.emmes.com/study/cord/sop.htm¹

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.

^1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.;Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.

Product No.	791-02, 791-02U
Description	Transfer/Freezing Bag Set
Fill Volume Range	Up to 200 mL in transfer bag 1; up to 150 mL in transfer bag 2; up to 25 mL in freezing bag
Port Configuration	Vented needle; in-line spike; in-line luer; (2) multi-use sampling ports; (2) pinch clamps
Materials of Construction	200 mL Transfer Bag: Polyvinyl chloride (PVC) with tri (2-ethylhexyl) trimelliate (TEHTM) plasticizer; 150 mL Transfer Bag: Polyvinyl chloride (PVC) with di (2-ethylhexyl) phthalate (DEHP) plasticizer; Freezing Bag: Ethyl vinyl acetate, a copolymer of polyethylene; Tubing: Ethylene vinyl acetate
Bag Size(s)	200 mL Transfer Bag: 17.53 cm length x 11.43 cm width (6.9 in. length x 4.50 in. width); 150 mL Transfer Bag: 14.86 cm length x 7.62 cm width (5.85 in. length x 3.0 in. width); Freezing Bag: 8.84 cm length x 7.04 cm width x 0.74 cm depth (3.48 in. length x 2.77 in. width x 0.29 in. depth)
Sterilization	Gamma
Packaging	Individually packaged in a plastic pouch; 24/box
Shelf Life	3 years
Traceability	Lot number
Regulatory Status	FDA 510(k) cleared; CE marked
Compatible with Other Bags	791-01; 791-03

Facilitate each step in the collection, processing, freezing and transfusion process for cord blood stem cells to ensure a safe, reliable, robust process. See these other Pall products for the collection, processing, and cryopreservation of blood and cellular components:

• Cord Blood Collection Set: For the collection of up to 150 mL of umbilical cord blood.  
• Cell Wash/Infusion Bag Set: For the thaw/washing and subsequent infusion of previously frozen cord blood stem cells.
• Freezing Bag: For the long-term storage of 25 mL of cryopreserved, concentrated blood components.

Dimethyl Sulfoxide (DMSO)/Dextran 40 Solution

Available in Europe only. A cryopreservative solution used for the preservation of concentrated stem cells in a frozen state. Product is designed and manufactured using Quality Systems that have been approved to ISO9001:2000 and ISO13485:2003 and to the Medical Device Directive (93/42/EEC). Product is CE marked.

Chemical Composition
Dimethyl Sulfoxide (DMSO) and Dextran 40 solutions are added to water for injection and mixed such that the final composition is 55% w/v DMSO and 5% w/v Dextran 40.

Volume
Each ambot contains 7.2 +/- 0.2 mL of DMSO/Dextran 40 solution. This is sufficient to deliver 5 mL of solution.

Packaging
Each non-pyrogenic glass ambot is aseptically sealed with a pre-sterilized non-pyrogenic stopper and a non-product contact, flip-top seal.

Storage
Ambots should be stored at 2 – 8 °C.

Product Code	Product Code (Europe)	Description	Packaging
791-02	791-02U	Transfer/Freezing Bag Set	24 units/case
	791-04U*	Dimethyl Sulfoxide (DMSO)/Dextran 40 Solution	24 units/case

*Note: Pall Product Code 791-04U is intended for use with Pall Product Code 791-02U (Transfer/Freezing Bag Set), and is available in Europe only.

 

To order, contact:

Pall Medical

Phone: 877.367.7255
Fax: 888.556.7337
pall@rxcrossroads.com

Pall Europe Ltd

Europa House, Havant Street
Portsmouth, PO1 3PD England
Tel: +44 (0)23 9230 3452
Fax: +44 (0)23 9230 3324
Biosvc@Pall.com

Pall Canada

2535 De Miniac
St-Laurent, Quebec H45 1E5
Tel: +1 514.332.7255
Toll-free in Canada: 800.465.8555
Fax: +1 514.332.0996

Pall's cord blood processing products are not available in Asia or Latin America. For cord blood processing products in Asia and Latin America, please contact your local Thermogenesis representative.

Access our complete list of Pall offices worldwide.