Development of new products
Project leader: Dirk de Korte PhD
From 2008 cryolijm-SQ, a fibrin glue of single donor plasma which Sanquin has started to produce as an alternative for autologous or pooled plasma fibrin glues is produced in a routine setting. In 2009 the Department of Transfusion Monitoring (TraM) started a formal stability study to officially confirm the two-year storage life of cryo-SQ.
The formal cryolijm-SQ stability study was completed in January 2012; all tested samples met the predetermined requirements.
To be able to produce autologous cryolijm and because of the interest in cryolijm-SQ from foreign countries, the production of cryolijm-SQ from whole blood derived plasma and fresh apheresis plasma was validated and approved in 2011. The shelf life study of whole blood derived plasma continued in 2012 and will be completed in 2013.
Austrian whole blood derived inline filtered plasma units could be used for the production of cryolijm-SQ for the European market. The validation was initiated in 2011 and completed in 2012: all tested samples met the predetermined requirements. Also for cryolijm-SQ produced from Austrian whole blood derived inline filtered plasma a shelf life study was initiated in 2012 and will be completed in 2014.
Sanquin is creating the possibility to transfer the technology of cryolijm-SQ production to foreign countries. A training program was developed and is practically ready. It has to be fine tuned at the time the first training courses are scheduled.
Other studies in correlation to cryolijm-SQ are:
- FIRST-study: For this study cryolijm-SQ is applied on patients that undergo knee-replace ment. The first inclusion was in January 2011 and the study is completed in 2013. A report is expected in 2014.
- Validation cryolijm-SQ transport: Cryolijm-SQ is now wrapped in a cardboard box instead of a plastic bag and also the cool boxes were replaced by new ones. Therefore, the cryolijm-SQ transport was validated in the new 17 and 24 liter campinggaz cool box and in an EPS cool box. All cool boxes were tested with the minimum and maximum amount of cryolijm-SQ present. Dry ice was placed at the bottom and top of the cryolijm-SQ at all times. The requirement was met; the temperature remained ≤-18°C..
- Extending clotting time: Cryolijm-SQ is particular suitable in achieving haemostasis. When used as an adhesive, in some cases a longer clotting time would be preferable. It was shown that it is possible to extend the clotting time by diluting the thrombin component of cryolijm-SQ. Diluting the thrombin component to a thrombin activity of 1.5 IU/mL leads to a clotting time of approximately 60 seconds. Also, the tensile strength is increased when using diluted thrombin to 1.5, 2.0, and 2.5 IU/mL compared to undiluted thrombin.
- Use of cryolijm-SQ for upper eyelid blepharoplasty: Together with the University Medical Centre Groningen, department plastic surgery a study was set up to investigate whether cryolijm-SQ can be used instead of sutures, so that the hospital visit to remove the sutures is not necessary. First pilots took place, but had not the desired result. Further pilots with diluted thrombin will be performed to study the applicability for patients undergoing upper eyelid blepharoplasty.
- Use of cryolijm-SQ for COPD: Together with the UMCG, department of pulmonary diseases, a study was set up to investigate the possibility for application of cryolijm-SQ in bronchoscopic lung volume reduction in patients suffering from COPD. In this way the diseased portions of the lung will be removed in order to enable the remaining healthier parts of the lung to function normally. In 2013 the first in vitro pilots are performed, which gave promising results. In 2014 further pilot experiments will be performed and approval from the medical ethical approval committee will be asked for performing clinical studies.
- Hazelaar S, Dijkstra-Tiekstra MJ, de Korte D, de Wildt-Eggen J. Allogeneic single-donor cryoseal produced from fresh-frozen quarantine aphaeresis plasma as alternative for multidonor or autologous fibrin sealants. Transfusion 2012; 52(3):517-23.
Figure 1: Diluted thrombin leads to an extended clotting time of cryolijm-SQ. Undiluted thrombin leads to a clotting time of cryolijm-SQ within 10 seconds.