Plasma for fractionation: looking at its safety from a comprehensive angle

Transfusion ◽  
2016 ◽  
Vol 56 (11) ◽  
pp. 2900-2901
Author(s):  
Thierry Burnouf
Keyword(s):  
Plasma For Fractionation

Plasma for Fractionation

2012 ◽  
pp. 423-436 ◽  
Author(s):  
Joseph Bertolini ◽  
Timothy Hayes
Keyword(s):  
Plasma For Fractionation

Recovered plasma for fractionation: call for quality standards to end wastage

Vox Sanguinis ◽  
2019 ◽  
Vol 115 (2) ◽  
pp. 213-214 ◽  
Author(s):  
Thierry Burnouf ◽  
Jay Epstein ◽  
Jean‐Claude Faber
Keyword(s):  
Quality Standards ◽  
Plasma For Fractionation

Quality control of recovered plasma for fractionation: an extensive Italian study

Transfusion ◽  
2008 ◽  
Vol 48 (7) ◽  
pp. 1459-1468 ◽  
Author(s):  
Giuliano Grazzini ◽  
Giuseppe Rossi ◽  
Daniela Rafanelli ◽  
Davide Gambelli ◽  
Claudio Farina ◽  
...  
Keyword(s):  
Quality Control ◽  
Italian Study ◽  
Plasma For Fractionation

Removal of Prions by the Manufacturing Process of Haemate® P/Humate-P®.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4171-4171
Author(s):  
Albrecht Groener ◽  
Wolfram Schäfer ◽  
Martin Vey
Keyword(s):  
Prion Protein ◽  
Human Blood ◽  
Manufacturing Process ◽  
Safety Margin ◽  
Reduction Factor ◽  
Department Of Health ◽  
Plasma For Fractionation ◽  
Causative Agents ◽  
Precautionary Measures ◽  
Prion Transmission

Abstract Prions, the causative agents of Creutzfeldt-Jakob Disease (CJD) and related neurodegenerative disorders in humans including variant CJD (vCJD) have up to now never been demonstrated in human blood although if in UK two probable transmissions of vCJD by blood transfusion were reported (Llewelyn et al., Lancet2004;363:417–421 and Peden et al., Lancet2004;364:527–529). In order to minimize a theoretical risk of human prion contamination of plasma pools, potential donors at risk of incubating CJD are excluded from donation permanently. Due to the implementation of these precautionary measures, the risk to collect plasma from a donor developing vCJD subsequent to a donation is very low. In addition, the amount of prions present in plasma of a healthy donor (i.e., a donor in the incubation period of (v)CJD) can be considered very low (Comer Risk Assessment of Exposure to vCJD Infectivity in Blood and Blood Products for Department of Health [UK], Revision DE, Det Nordske Veritas, February 2003). Even with this very low risk related to plasma for fractionation, the capacity of selected steps of the manufacturing process of the VWF/FVIII product Haemate® P/Humate-P® to remove prions has been evaluated in prion removal studies. As it has never been possible to isolate infectious prion protein, termed PrPSc, from human blood or plasma, the model prion strain 263K (isolated from brain of deliberately infected hamsters) was spiked to intermediates of scaled-down plasma protein purification processes. As there is no knowledge of the biophysicochemical nature of potential prion contaminants in plasma, we employed two different prion spike preparations in these studies: membrane associated prions in so-called microsomes and purified prion protein PrPSc, an almost native, molecular, non-membrane associated form of prion infectivity. Laboratory studies were performed by spiking either experimental plasma pools or an intermediate at a production stage further downstream with prion preparations and investigating the prion reduction by consecutive scaled-down process steps. These investigational studies resulted in a mean overall prion reduction factor of 5.3 log10 and 6.4 log10, respectively, for the two hamster derived spike preparations. Reduction of prions by selected manufacturing steps for Haemate® P/Humate-P® Manufacturing stages Prion Reduction Factor [log 10 ] Microsomes PrPSc Combined steps cryoprecipitation, Al(OH)3, glycine and NaCl precipitation 3.5 3.9 Combined steps ultracentrifugation/sterile filtration 1.8 2.5 Mean Overall Prion Reduction 5.3 6.4 Additionally, confirmative data were obtained in studies employing human brain-derived prion preparations (sCJD and vCJD) as spiking material in selected studies of a single manufacturing step. Therefore, it can be concluded that the risk of prion transmission by the VWF/FVIII product Haemate® P/Humate-P® is extremely remote based on complementary safety procedures, i.e., collection of plasma by stringent donor selection and the overall prion reduction factor which clearly exceeds a potential prion load in the manufacturing pool. This high safety margin is confirmed in a probabilistic risk calculation, demonstrating at a probability of 95% a safety factor for each vial of the product of 6.4 log10.

scholarly journals Analysis of two human parvovirus PARV4 genotypes identified in human plasma for fractionation

2007 ◽  
Vol 88 (8) ◽  
pp. 2162-2167 ◽  
Author(s):  
Jacqueline F. Fryer ◽  
Eric Delwart ◽  
Flavien Bernardin ◽  
Philip W. Tuke ◽  
Vladimir V. Lukashov ◽  
...  
Keyword(s):  
High Titre ◽  
Full Length ◽  
Open Reading Frames ◽  
The Novel ◽  
Medicinal Products ◽  
Plasma For Fractionation ◽  
Extended Analysis ◽  
Related Variant ◽  
Overlapping Open Reading Frames ◽  
Reading Frames

The presence of the novel parvovirus PARV4 and a related variant, PARV5, was recently demonstrated in pooled plasma used in the manufacture of blood and plasma-derived medicinal products. DNA sequence analysis of nearly full-length genomes of four PARV4 and two PARV5 strains from manufacturing plasma pools is now presented. Like PARV4, PARV5 encodes two non-overlapping open reading frames (ORF1 and ORF2), homologous to the non-structural and capsid proteins of other parvoviruses, respectively. A highly conserved region in ORF2 contains phospholipase A2 motifs involved in parvovirus infectivity. Hybridization of strand-specific probes to DNA extracted from high-titre, PARV4-positive plasma revealed that the positive and negative strands are packaged into PARV4 virions in similar quantities. This extended analysis of nearly full-length PARV4 and PARV5 sequences suggests that they are closely related genotypes and the use of a single virus name, PARV4, comprising genotypes 1 and 2 (previously termed PARV5) is proposed.

scholarly journals Specific protein content of pools of plasma for fractionation from different sources: impact of frequency of donations

Vox Sanguinis ◽  
2010 ◽  
Vol 99 (3) ◽  
pp. 220-231 ◽  
Author(s):  
R. Laub ◽  
S. Baurin ◽  
D. Timmerman ◽  
T. Branckaert ◽  
P. Strengers
Keyword(s):  
Protein Content ◽  
Specific Protein ◽  
Plasma For Fractionation ◽  
Different Sources
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