scholarly journals Retention of Coagulation Factors and Storage of Freeze-Dried Plasma

2021 ◽  
Vol 186 (Supplement_1) ◽  
pp. 400-407
Author(s):  
Elissa J Flaumenhaft ◽  
Terry Khat ◽  
Susanne Marschner

ABSTRACT Introduction Terumo BCT is developing a system to produce a freeze-dried plasma product, Terumo’s freeze-dried plasma (TFDP), that is stored in a rugged, light-weight plastic package suitable for field use, which retains a stable level of specific coagulation factors and proteins within clinical range, when stored for up to 2 years at room temperature and 4°C. Materials and Methods Plasma frozen within 24 hours of phlebotomy (PF24) were thawed, sampled, and individually lyophilized to produce a corresponding TFDP unit. Fresh frozen plasma (FFP) units were thawed, sampled, pooled in groups of 10 units (also sampled) and lyophilized to produce 2 lots of TFDP. Each TFDP unit was reconstituted with water for injection (WFI) and tested for pH, prothrombin time, activated partial thromboplastin time, factors V and VIII, fibrinogen, protein C, and protein S. Results were compared with PF24/FFP. Additional FFP units were thawed, sampled, pooled, divided to generate 2 TFDP units for each time point (1, 2, 3, 6, 12, 18, and 24 months, one each stored at 4°C and 25°C) and lyophilized. Postlyophilization, TFDP units were stored at 4°C or 25°C, reconstituted with WFI, and tested for the factors listed above. Residual moisture content of the lyophilized plasma was also tested. Results Coagulation factor activity of TFDP was ±20% of PF24/FFP. Pooling standardized variation in TFDP coagulation factor activities, which were within clinical ranges postlyophilization. The pH of TFDP and PF24/FFP were within required range. Residual moisture content of TFDP was <2%. Conclusions The TFDP process had no negative impact on coagulation factor activity. Input plasma and anticoagulant type did not affect TFDP quality. Pooling FFP normalized factor variability in TFDP and did not negatively impact product quality. The TFDP is stable for up to 24 months at room and refrigerated temperatures. Terumo’s freeze-dried plasma is comparable to PF24/FFP. It does not require complex logistics or time-consuming thawing. Terumo’s freeze-dried plasma may be suitable for rapid treatment of coagulopathies with logistical advantages over PF24/FFP.

1997 ◽  
Vol 62 (4) ◽  
pp. 693-695 ◽  
Author(s):  
PABLO BONELLI ◽  
CAROLINA SCHEBOR ◽  
ANA L. CUKIERMAN ◽  
MARIA P. BUERA ◽  
JORGE CHIRIFE

1985 ◽  
Vol 49 (2) ◽  
pp. 413-415 ◽  
Author(s):  
Graciela F. de Valdez ◽  
Graciela S. de Giori ◽  
Aida P. de Ruiz Holgado ◽  
Guillermo Oliver

2021 ◽  
Author(s):  
Shavkat Khurramov ◽  
Farkhad Khalturaev ◽  
Eshmurad Buriyev

Molecules ◽  
2020 ◽  
Vol 25 (3) ◽  
pp. 474
Author(s):  
Daanvir K. Dhir ◽  
Armin Rashidi ◽  
Grant Bogyo ◽  
Ron Ryde ◽  
Sepideh Pakpour ◽  
...  

Natural fibers are gaining wide attention due to their much lower carbon footprint and economic factors compared to synthetic fibers. The moisture affinity of these lignocellulosic fibres, however, is still one of the main challenges when using them, e.g., for outdoor applications, leading to fast degradation rates. Plastination is a technique originally used for the preservation of human and animal body organs for many years, by replacing the water and fat present in the tissues with a polymer. This article investigates the feasibility of adapting such plastination to bamboo natural fibres using the S-10 room-temperature technique in order to hinder their moisture absorption ability. The effect of plastination on the mechanical properties and residual moisture content of the bamboo natural fibre samples was evaluated. Energy dispersive x-ray spectroscopy (EDS) and X-ray micro-computed tomography (Micro-CT) were employed to characterize the chemical composition and 3-dimensional morphology of the plastinated specimens. The results clearly show that, as plastination lessens the hydrophilic tendency of the bamboo fibres, it also decreases the residual moisture content and increases the tensile strength and stiffness of the fibers.


Processes ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 127 ◽  
Author(s):  
Alicia Conde-Islas ◽  
Maribel Jiménez-Fernández ◽  
Denis Cantú-Lozano ◽  
Galo Urrea-García ◽  
Guadalupe Luna-Solano

The purpose of this study was to investigate how the properties of Mexican kefir grains (MKG) are affected by the operating parameters used in the freeze-drying process. The factors investigated were the freezing time (3–9 h), freezing temperature (−20 to −80 °C), pressure (0.2–0.8 mbar), and lyophilization time (5–20 h). The maximum range of change and one-way analysis of variance showed that lyophilization time and freezing time significant affects (p < 0.05) the response variables, residual moisture content and water activity, and pressure had a significant effect on the color difference and survival rate of probiotic microorganisms. The best drying conditions were a freezing time of 3 h, a freezing temperature of −20 °C, a pressure of 0.6 mbar, and a lyophilization time of 15 h. Under these conditions, we obtained a product with residual moisture content below 6%, water activity below 0.2, and survival rates above 8.5 log cfu per gram of lactic acid bacteria and above 8.6 log for yeast.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4149-4149
Author(s):  
Jean-Pierre Cazenave ◽  
Hervé Isola ◽  
Marie-Louise Wiesel ◽  
Daniel Kientz ◽  
Michel Laforêt ◽  
...  

Abstract Background. A photochemical treatment (PCT) using amotosalen HCl (S-59) and UVA light was developed to inactivate pathogens and leukocytes in therapeutic plasma (INTERCEPT™, I-FFP) frozen within 8 hr of collection. Previous studies demonstrated a broad spectrum of pathogen inactivation (Transfusion2006;46:1168) and clinical efficacy of I-FFP for support of coagulopathies (Transfusion2005;45:1362; Blood2006; 107:3753), and plasma exchange of TTP (Transfusion 2006;46). Preparation of therapeutic plasma from whole blood would complement blood center logistics and reduce the cost of therapeutic frozen plasma provided sufficient coagulation factors were retained. Aims. We measured coagulation factors in plasma isolated from whole blood held overnight at controlled temperature (21 ± 3°C), processed with pathogen inactivation, and frozen within 18 hr of blood collection. Methods. Whole blood units, approximately 460 mL, anticoagulated with CPD (Baxter, La Chatre, France) were drawn from group A, O, B and AB donors. Units were processed after 16 hr storage, and plasma was isolated by centrifugation. Two to 3 plasma units of matched blood group were pooled (n = 30: A = 14, O = 14, B = 1, AB =1) to a final volume of 635 mL. Baseline samples for assay of coagulation factors were withdrawn. Each of 30 pools was mixed with 15 mL of 6 mM amotosalen (150 uM: final concentration) and illuminated with a 3 J/cm2 UVA treatment. Following illumination (~ 8 min) and passage through a flow compound adsorption device (~20 min) to reduce levels of residual S-59, treated plasma units (650 mL) were divided into 3 equal storage units of ≥ 200 mL. Before freezing, post-treatment samples for assay of coagulation factors were withdrawn for assay of coagulation factors. Treated plasma units were flash frozen at -80°C, and transferred to −30°C for 12-month storage. Treated units were withdrawn after 1 month to measure total protein, albumin, IgG, IgM, IgA, fibrinogen, factors II, V, VII, VIII, IX, X, XI, XII, VIII-vWF, Proteins C and S, AT III, plasminogen, alpha-2 antiplasmin, D-dimers, PT, and APTT. Results. Baseline coagulation factor levels (Mean ± SD) were in suitable therapeutic ranges. After PCT, all units had residual platelets &lt; 1×109/L, WBC &lt; 1×104/L, and RBC &lt; 1 × 109/L. After PCT and frozen storage for 1 month, total protein (59 ± 2 g/L), albumin (38 ± 1 g/L), IgG (8.9 ± 1.1g/L), IgA (1.8 ± 0.4 g/L) and IgM (0.9 ± 0.3 g/L) were unchanged from baseline. Mean values for fibrinogen (g/L), coagulation factors (IU/dL), coagulation inhibitors (IU/dL), were variably reduced from baseline, but within ranges defined as suitable for therapeutic plasma (Table). There was no evidence of plasma activation. Conclusions. Plasma prepared from whole blood after storage on cooling plates before processing with the INTERCEPT system for pathogen inactivation retained coagulation factor activity levels after frozen storage (−30°C) in conformance with French national standards for therapeutic frozen plasma (FP). Approximately 36 units (200 mL) could be prepared per hr of illumination time with this system.


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