Pathogen safety of Beriate®

Gröner, Albrecht

doi:10.1016/j.thromres.2013.10.013

Cited by 6 publications

(6 citation statements)

References 21 publications

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“…Currently, many complementary safety measures are in place to prevent the transmission of blood‐borne viruses by the administration of commercial plasma‐derived products. These measures include licensed blood and plasma collection centers with appropriate epidemiology regarding HIV, HCV, and HBV in plasma donors, mandatory and voluntary testing of all donations for these viruses as well as for HAV and high titers of B19V, releasing plasma pools for fractionation for further manufacturing only when nonreactive for virus markers (and not exceeding 10 4 B19V DNA IU/mL), and the implementation of effective virus reduction steps in the manufacturing process of plasma‐derived products . Based on these measures the risk of transmitting blood‐borne viruses via the administration of plasma‐derived products is very remote.…”

Section: Discussionmentioning

confidence: 99%

Effective inactivation of a wide range of viruses by pasteurization

et al. 2017

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BACKGROUND Careful selection and testing of plasma reduces the risk of blood‐borne viruses in the starting material for plasma‐derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood‐borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment. STUDY DESIGN AND METHODS The virus inactivation kinetics of pasteurization for a broad range of viruses were evaluated in the relevant intermediates from more than 15 different plasma manufacturing processes. Studies were carried out under the routine manufacturing target variables, such as temperature and product‐specific stabilizer composition. Additional studies were also performed under robustness conditions, that is, outside production specifications. RESULTS The data demonstrate that pasteurization inactivates a wide range of enveloped and nonenveloped viruses of diverse physicochemical characteristics. After a maximum of 6 hours' incubation, no residual infectivity could be detected for the majority of enveloped viruses. Effective inactivation of a range of nonenveloped viruses, with the exception of nonhuman parvoviruses, was documented. CONCLUSION Pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against known blood‐borne pathogens and emerging or potentially emerging viruses. Pasteurization has proven itself to be a highly effective step, in combination with other complementary safety measures, toward assuring the virus safety of final product.

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Section: Discussionmentioning

confidence: 99%

Effective inactivation of a wide range of viruses by pasteurization

et al. 2017

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“…[20][21][22][23] Over the course of the following years, nanofiltration was introduced also into the manufacturing of cell-derived biologics, including recombinant proteins, derived from mammalian cells or mammalian origin. [24][25][26][27][28][29] Today, nanofiltration is standardly used in the manufacturing processes of PDMPs, such as immunoglobulins (IgG), [30][31][32] coagulation factors such as von Willebrand Factor (vWF), 33 Factor VIII (FVIII), 34,35 Factor IX (FIX), and prothrombin complex, 18,36 and inhibitors such as alpha1-protease inhibitor (A 1 PI), 37,38 antithrombin (ATIII), 39 and C1-esterase inhibitor. [40][41][42] PPTA member companies performed a retrospective data collection and analysis of the virus removal capacity validation data for nanofiltration steps for variety of commercial PDMPs using 15 to 20 nm and 35 to 50 nm nanofiltration platforms.…”

Section: Abstract Plasma Derivativesmentioning

confidence: 99%

Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers

et al. 2020

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Background: Nanofiltration entails the filtering of protein solutions through membranes with pores of nanometric sizes that have the capability to effectively retain a wide range of viruses. Study Design and Methods: Data were collected from 754 virus validation studies (individual data points) by Plasma Protein Therapeutics Association member companies and analyzed for the capacity of a range of nanofilters to remove viruses with different physicochemical properties and sizes. Different plasma product intermediates were spiked with viruses and filtered through nanofilters with different pore sizes using either tangential or dead-end mode under constant pressure or constant flow. Filtration was performed according to validated scaled-down laboratory conditions reflecting manufacturing processes. Effectiveness of viral removal was assessed using cell culture infectivity assays or polymerase chain reaction (PCR). Results: The nanofiltration process demonstrated a high efficacy and robustness for virus removal. The main factors affecting nanofiltration efficacy are nanofilter pore size and virus size. The capacity of nanofilters to remove smaller, nonenveloped viruses was dependent on filter pore size and whether the nanofiltration process was integrated and designed with the intention to provide effective parvovirus retention. Volume filtered, operating pressure,

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“…From the measured LRVs, the filtration operation is usually classified as effective (LRV [ 4), moderately effective (1 \ LRV \ 4) or Adapted from Makino et al (1994) Rev Environ Sci Biotechnol (2017) ineffective (LRV \ 1) (Phillips et al 2007). Since filtration complements other viral clearance methods in the downstream processing of biotherapeutics (Brorson 2007;Klamroth et al 2014;Shukla et al 2007), several studies quoted in Table 1 also report LRVs for common virus reduction steps such as inactivation by pasteurization (Gröner 2014;Gröner et al 2012;Terpstra et al 2007) or solvent/detergent treatment (Dichtelmüller et al 2012;Terpstra et al 2006), and chromatographic capture (Gröner 2014;Gröner et al 2012). Virus removal during the plasma fractionation process (Bryant and Klein 2007) leading from the crude plasma pool to the product (immunoglobulin here) stream has also been quantified (Dichtelmüller et al 2012;Koenderman et al 2012;Terpstra et al 2006).…”

Section: Regenerated Cellulose Hollow Fiber (Hf) Membrane Filtersmentioning

confidence: 99%

“…This was not the case when 35N was used as the main viral filter after pre-filtration with 75N (Dichtelmüller et al 2012), which confirms previous date showing that the 35 nm pore size was too large to retain the smallest viral particles (Furuya et al 2006;Hongo-Hirasaki et al 2006). Both 20N (Caballero et al 2014;Furuya et al 2006;Gröner 2014) and 15N (Caballero et al 2014;Roberts et al 2010;Terpstra et al 2007;) Planova filters and their combination (Gröner et al 2012;Koenderman et al 2012) showed effective virus removal over a wide range of viral particle sizes (Table 1). As a general rule, the removal efficiency of the filters increased with the ratio of pore size to virus size, as illustrated by Gröner (2014) and Terpstra et al (2007).…”

Section: Regenerated Cellulose Hollow Fiber (Hf) Membrane Filtersmentioning

confidence: 99%

“…Both 20N (Caballero et al 2014;Furuya et al 2006;Gröner 2014) and 15N (Caballero et al 2014;Roberts et al 2010;Terpstra et al 2007;) Planova filters and their combination (Gröner et al 2012;Koenderman et al 2012) showed effective virus removal over a wide range of viral particle sizes (Table 1). As a general rule, the removal efficiency of the filters increased with the ratio of pore size to virus size, as illustrated by Gröner (2014) and Terpstra et al (2007). This was also demonstrated by Roberts et al (2010) by filtrating poliovirus type 1 (a picorvanirus) through Planova filters manufactured with different pore sizes, ranging between 15 (LRV = 6.9) and 35 nm (LRV = 0.2).…”

Section: Regenerated Cellulose Hollow Fiber (Hf) Membrane Filtersmentioning

confidence: 99%

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