Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection from Plasma Protein Therapeutics Association member companies

Dichtelmüller, H.; Biesert, Lothar; Fabbrizzi, Fabrizio; Falbo, Anna; Flechsig, Eckhard; Gröner, Albrecht; Hoegen, Ilka von; Kempf, Christoph; Kreil, Thomas R.; Lee, Douglas C.; Pölsler, Gerhard; Roth, Nathan

doi:10.1111/j.1537-2995.2010.03003.x

Cited by 22 publications

(10 citation statements)

References 23 publications

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“…Human herpes viruses studied were inactivated faster than PRV, verifying the use of PRV as a worse‐case model virus in virus validation studies. It should be noted that PRV and herpesviruses are large and, therefore, effectively removed by small‐ (15‐20 nm) and large‐pore (35‐75 nm) virus filtration, partitioned by fractionation steps, and are susceptible to other inactivation steps (e.g., Dichtelmüller et al).…”

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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“…Gammagard liquid (in the United States) and KIOVIG (in Europe) are Baxalta's 10% liquid human immune globulin infusions (in the following referred to as GG/KIOVIG), manufactured from pooled human plasma by the same process . The virus removal capacity of the extraction of fraction II+III paste was evaluated as previously described . Virus removal was investigated at the different pH extremes that are defined for manufacturing (pH 6.6 and 6.8).…”

Section: Methodsmentioning

confidence: 99%

Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes

et al. 2015

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“…209 However, it is still important to continue to monitor patients on replacement therapy for transmission of unknown or new pathogenic agents. Measurement of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be performed once or twice annually; significant persistent elevation should be investigated.…”

Section: Managementmentioning

confidence: 99%

International Consensus Document (ICON): Common Variable Immunodeficiency Disorders

Bonilla

Barlan

Chapel

et al. 2016

The Journal of Allergy and Clinical Immunology: In Practice

705

772

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The International Collaboration in Asthma, Allergy and Immunology initiated an international coalition among the American Academy of Allergy, Asthma & Immunology; the European Academy of Allergy and Clinical Immunology; the World Allergy Organization; and the American College of Allergy, Asthma & Immunology on common variable immunodeficiency. An author group was formed and then divided into individual committees. Within the committee, teams of authors were subgrouped to generate content for specific sections of the document. Content was derived from literature searches, relevant published guidelines, and clinical experience. After a draft of the document was assembled, it was collectively reviewed and revised by the authors. Where evidence was lacking or conflicting, the information presented represents the consensus expert opinion of the group. The full document was then independently reviewed by 5 international experts in the field, none of whom was among the authors of the original. The comments of these reviewers were incorporated before submission for publication.

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Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection from Plasma Protein Therapeutics Association member companies

Cited by 22 publications

References 23 publications

Effective inactivation of a wide range of viruses by pasteurization

Effective inactivation of a wide range of viruses by pasteurization

Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes

International Consensus Document (ICON): Common Variable Immunodeficiency Disorders

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