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Variability of in vivo potency tests of Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccines.
Stalpers, Coen A L; Retmana, Irene A; Pennings, Jeroen L A; Vandebriel, Rob J; Hendriksen, Coenraad F M; Akkermans, Arnoud M; Hoefnagel, Marcel H N.
Afiliação
  • Stalpers CAL; CBG-MEB, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands; RIVM, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands; Division of Immunology, Department of Infectious Diseases and Immunology, Utrecht University, Yalelaan 1, 3584 CL Utrecht, the Netherlands.
  • Retmana IA; CBG-MEB, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands.
  • Pennings JLA; RIVM, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands.
  • Vandebriel RJ; RIVM, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands.
  • Hendriksen CFM; Intravacc, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands.
  • Akkermans AM; RIVM, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands.
  • Hoefnagel MHN; CBG-MEB, Graadt van Roggenweg 500, 3531 AH Utrecht, the Netherlands. Electronic address: mh.hoefnagel@cbg-meb.nl.
Vaccine ; 39(18): 2506-2516, 2021 04 28.
Article em En | MEDLINE | ID: mdl-33824038
For batch release of legacy vaccines such as DTaP, in vivo potency release assays are required. We quantified the variability of in vivo potency release assays for four DTaP (Diphtheria, Tetanus, acellular Pertussis) products of different manufacturers. With their large CV (Coefficients of Variance) ranging from 16% to 132%, these in vivo assays are of limited value to ensure their potency is consistent and similar to the clinical batches used for the marketing authorisation. Our data show that, although individual potency test results show high variability, the DTaP batches are manufactured with great consistency, because repeated potency testing yields similar averages for the different batches. The economic impact of variability of in vivo tests is significant since it may result in the need for greater amount of antigen than may be required or for repeating a test. For monitoring the consistency of potency, in vitro assays are superior to in vivo assays. Animal-free potency determination is common practice for newly developed vaccines under modern GMP quality systems. However, replacement of in vivo potency tests for legacy vaccines like DTaP is challenging and would require a 'reverse characterisation' strategy in which the antigens are further characterised at the level of drug substance and drug product to identify critical quality attributes (CQA) that can be tested with in vitro assays. Based on these an updated set of release tests without animal tests can be proposed. Our data can serve as benchmark for the innovative methods.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tétano / Coqueluche / Vacinas contra Difteria, Tétano e Coqueluche Acelular / Difteria Limite: Animals Idioma: En Revista: Vaccine Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Holanda País de publicação: Holanda

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tétano / Coqueluche / Vacinas contra Difteria, Tétano e Coqueluche Acelular / Difteria Limite: Animals Idioma: En Revista: Vaccine Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Holanda País de publicação: Holanda