Product and Process Development Blood Bank
Manager: Dirk de Korte PhD
Development of a new red cell concentrate (RCC) for intra-uterine-transfusions (IUT)
With the use of low volume (100-200 ml) whole blood, RCC for IUT could be produced with at least similar, if not better, product quality than the current reference product. The advantage of the new product is that donor exposure and donor-mother blood group matching can be improved. Based on the proof-of–principle outcome, this new product will be implemented in routine in 2015.
Development of a pooled serum product
Development of a pooled serum product to be used in cell cultures for cellular therapies (so-called indirect application). The serum is 2x tested (released after a quarantine period), heat inactivated to destroy complement, tested for absence of anti-HLA antibodies, endotoxin and bacteria. The pooled serum is on research-only base available in 2014 and will be implemented in product assortment in 2015.
Development of allogeneic serum eye drops (SEDs)
Development of allogeneic serum eye drops (SEDs) for treatment of patients with severe dry eyes and other eye diseases. Serum is used in ophthalmic cases where conventional eye drops have insufficient effect. The use of SEDs in dry eye patients usually has a rapid effect, all symptoms improve within 48 hours.
Creating autologous SEDs is often problematic for a number of reasons, and the Radboud UMC together with Sanquin will conduct a trial comparing autologous versus allogeneic SEDs. In the meantime, in vitro studies conducted by Sanquin showed that there is no relevant difference in the composition of autologous and allogeneic serum.
Since 2008, Sanquin is producing Cryolijm-SQ, a fibrin glue of single donor plasma as an alternative for autologous or pooled plasma fibrin glues. In the period June 2014 to January 2015, a project is running to improve the disposables for production and application in the clinic, in joint cooperation with Recuperate Medical BV.
Guidance for QA
To develop guidance for QA in case of temperature deviations of blood and blood products, a series of studies was performed to learn more about the effect of short-lasting temperature deviations on in vitro quality. The results of these studies are summarized in an appendix for the Sanquin Guideline Blood Products (Richtlijn Bloedproducten) and also partly published in international literature.
With the consolidation of Production in Nijmegen and Amsterdam and restructuring the network of distribution points, the department ran several projects to show that product quality was not affected by longer traveling distances and changed working hours. One of the studies was to investigate which time-lines for the use of whole blood for production of buffy coat-derived platelet concentrate could be used, with minimal and maximal resting time of the whole blood, respectively buffy coats and buffy coat pools.
Support in qualifying products during validation of Multi-Component-Collections (MCC), performed by various apheresis platforms. With MCC from one donor a RCC, a double platelet product (in additive solution) and a small unit of plasma can be collected in one procedure of about 100 minutes. Validation for one platform is finished, for two other platforms validation is planned to be finished in first half of 2015.
Since January 2014 the Dept or Transfusion Monitoring (TRAM, location Groningen, division Research) is moved to PPO Blood Bank.
De Korte, Dirk (D) PhD
Dijkstra-Tiekstra, Margriet (M) PhD (location Groningen, former department TRAM, Sanquin Research)
Lagerberg, Johan (J) PhD
Van der Meer, Pieter (PF) PhD
Vrielink, Hans (H) MD PhD
Bontekoe, Ido (I)
Daal, Brunette (B)
De Laleijne-Liefting, Lara (LAE)
Hoenderdaal, Rob (R)
Karssing-van Leeuwen, Willy (W)
Korsten, Herbert (H)
Kraan, Marcha (M) (location Groningen, former dept TRAM, Sanquin Research)
Lorinser, Jos (JE)
Sybrands, Davina (DS)
Bontekoe IJ, van der Meer PF, de Korte D. Determination of thromboelastographic responsiveness in stored single-donor platelet concentrates. Transfusion 2014; 54(6):1610-8.
Bontekoe IJ, van der Meer PF, Mast G, de Korte D. Separation of centrifuged whole blood and pooled buffy coats using the new CompoMat G5: 3 years experience. Vox Sang 2014; 107(2):140-7.
De Cuyper IM, Meinders M, van de Vijver E, de Korte D, Porcelijn L, de Haas M, Eble JA, Seeger K, Rutella S, Pagliara D, et al. A novel flow cytometry-based platelet aggregation assay. Blood 2013; 121(10):e70-e80.
Lagerberg JW, Salado-Jimena JA, Lof H, Bontekoe IJ, Nielsen C, Verheggen C, van Waeg G, van der Meer PF, de Korte D, Hansen MB, et al. Evaluation of the quality of blood components obtained after automated separation of whole blood by a new multiunit processor. Transfusion 2013; 53(8):1798-807.
Prowse CV, de Korte D, Hess JR, van der Meer PF. Commercially available blood storage containers. Vox Sang 2014; 106(1):1-13.
van der Meer PF, Reesink HW, Panzer S, Wong J, Ismay S, Keller A, Pink J, Buchta C, Compernolle V, Wendel S, et al. Should DEHP be eliminated in blood bags? Vox Sang 2014; 106(2):176-95.
van der Meer PF, Karssing-van LW, Kurtz J, Spengler HP, Blair A, Devine D, Harrison P, Lambrecht B, Vandenbroeke T, de Wildt-Eggen J, et al. A flow cytometric method for platelet counting in platelet concentrates. Transfusion 2012; 52(1):173-80.