Djuna Z de Back1, Richard Vlaar1, Boukje Beuger1, Brunette Daal2, Johan Lagerberg2, Alexander P J Vlaar3, Dirk de Korte1,2, Marian van Kraaij4, Robin van Bruggen1. 1. Department of Blood Cell Research, Sanquin Research, and Landsteiner Laboratory, University of Amsterdam, Amsterdam, The Netherlands. 2. Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands. 3. Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, The Netherlands. 4. Departments of Donor Affairs and Transfusion Medicine, Sanquin Blood Bank, Centre of Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.
Abstract
BACKGROUND: Several circumstances require the accurate measurement of red blood cell (RBC) survival and clearance, such as determination of posttransfusion recovery of stored RBCs to investigate the effect of new additive solutions. To this end, biotin as a marker of RBCs to track donor RBCs in the blood of the recipient has been used in many studies. However, so far only experimental, nonvalidated, biotin-labeled red cell concentrates (RCCs) are transfused. The goal of this study was to produce a standardized biotin-labeled RCC product in a fast, simple, and sterile manner that can be used for clinical research and for the evaluation of new blood products according to Good Practice Guidelines (GPG) for blood establishments. STUDY DESIGN AND METHODS: RCC fractions were labeled with two different concentrations of biotinylation reagent in a closed system, to prevent bacterial contamination of the end product. Using flow cytometry, the reproducibility and robustness of the biotin labeling was assessed, as well as the stability of the biotin label on the (un-)irradiated RCC fraction. Additionally, parameters such as phosphatidylserine (PS) exposure, sodium (Na), potassium (K), free hemoglobin, adenosine triphosphate (ATP), pH, and morphology were determined prior to and after biotin labeling to rule out detrimental effects of the labeling procedure on the RCC. RESULTS: Our data show that RCCs can be labeled under sterile conditions in a closed system with two different biotinylation reagent concentrations, without affecting the biological activity. CONCLUSION: An easy, rapid (<2 hr), and robust method was developed to manufacture biotin-labeled RCCs for clinical research compliant to GPG.
BACKGROUND: Several circumstances require the accurate measurement of red blood cell (RBC) survival and clearance, such as determination of posttransfusion recovery of stored RBCs to investigate the effect of new additive solutions. To this end, biotin as a marker of RBCs to track donor RBCs in the blood of the recipient has been used in many studies. However, so far only experimental, nonvalidated, biotin-labeled red cell concentrates (RCCs) are transfused. The goal of this study was to produce a standardized biotin-labeled RCC product in a fast, simple, and sterile manner that can be used for clinical research and for the evaluation of new blood products according to Good Practice Guidelines (GPG) for blood establishments. STUDY DESIGN AND METHODS: RCC fractions were labeled with two different concentrations of biotinylation reagent in a closed system, to prevent bacterial contamination of the end product. Using flow cytometry, the reproducibility and robustness of the biotin labeling was assessed, as well as the stability of the biotin label on the (un-)irradiated RCC fraction. Additionally, parameters such as phosphatidylserine (PS) exposure, sodium (Na), potassium (K), free hemoglobin, adenosine triphosphate (ATP), pH, and morphology were determined prior to and after biotin labeling to rule out detrimental effects of the labeling procedure on the RCC. RESULTS: Our data show that RCCs can be labeled under sterile conditions in a closed system with two different biotinylation reagent concentrations, without affecting the biological activity. CONCLUSION: An easy, rapid (<2 hr), and robust method was developed to manufacture biotin-labeled RCCs for clinical research compliant to GPG.
Authors: Donald M Mock; Demet Nalbant; Svetlana V Kyosseva; Robert L Schmidt; Guohua An; Nell I Matthews; Alexander P J Vlaar; Robin van Bruggen; Dirk de Korte; Ronald G Strauss; José A Cancelas; Robert S Franco; Peter Veng-Pedersen; John A Widness Journal: Transfusion Date: 2018-05-16 Impact factor: 3.157
Authors: Tamir Kanias; Mars Stone; Grier P Page; Yuelong Guo; Stacy M Endres-Dighe; Marion C Lanteri; Bryan R Spencer; Ritchard G Cable; Darrell J Triulzi; Joseph E Kiss; Edward L Murphy; Steve Kleinman; Mark T Gladwin; Michael P Busch; Alan E Mast Journal: Transfusion Date: 2018-11-26 Impact factor: 3.157
Authors: Albert D Donnenberg; Tamir Kanias; Darrell J Triulzi; Catherine J Dennis; E Michael Meyer; Mark Gladwin Journal: Transfusion Date: 2019-06-06 Impact factor: 3.337
Authors: Donald M Mock; Sean R Stowell; Robert S Franco; Svetlana V Kyosseva; Demet Nalbant; Robert L Schmidt; Gretchen A Cress; Ronald G Strauss; José A Cancelas; Melissa von Goetz; Anne K North; John A Widness Journal: Transfusion Date: 2022-03-11 Impact factor: 3.337
Authors: Sanne de Bruin; Emma K van de Weerdt; Davina Sijbrands; Richard Vlaar; Eric Gouwerok; Bart J Biemond; Alexander P J Vlaar; Robin van Bruggen; Dirk de Korte Journal: Transfusion Date: 2019-07-18 Impact factor: 3.157
Authors: Sanne de Bruin; Anna-Linda Peters; Marije Wijnberge; Floor E H P van Baarle; Amira H A AbdelRahman; Christie Vermeulen; Boukje M Beuger; Julie A Reisz; Angelo D'Alessandro; Alexander P J Vlaar; Dirk de Korte; Robin van Bruggen Journal: Blood Adv Date: 2022-07-12