PAT for vaccines: The first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease

Streefland, Mathieu; Waterbeemd, Bas van de; Happe, H. Kevin; Pol, Leo A. van der; Beuvery, E. C.; Tramper, J.; Martens, Dirk E.

doi:10.1016/j.vaccine.2007.01.015

Cited by 31 publications

(46 citation statements)

References 16 publications

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“…We also assessed the SNP density in gene categories based on Bvg regulation (26, 27). For this, three categories were defined: genes activated, repressed, or unaffected by Bvg (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Together with at least 425 other genes, the genes for the five B. pertussis proteins used in ACVs belong to the so-called Bordetella virulence gene (Bvg) regulon, consisting of a sensory transduction system which translates environmental cues into changes in gene expression (26, 27). Low temperatures and high sulfate and nicotinic acid concentrations are signals known to suppress genes in the Bvg regulon (28).…”

Section: Introductionmentioning

confidence: 99%

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Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination

Bart

Harris

Advani

et al. 2014

mBio

253

350

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Bordetella pertussis causes pertussis, a respiratory disease that is most severe for infants. Vaccination was introduced in the 1950s, and in recent years, a resurgence of disease was observed worldwide, with significant mortality in infants. Possible causes for this include the switch from whole-cell vaccines (WCVs) to less effective acellular vaccines (ACVs), waning immunity, and pathogen adaptation. Pathogen adaptation is suggested by antigenic divergence between vaccine strains and circulating strains and by the emergence of strains with increased pertussis toxin production. We applied comparative genomics to a worldwide collection of 343 B. pertussis strains isolated between 1920 and 2010. The global phylogeny showed two deep branches; the largest of these contained 98% of all strains, and its expansion correlated temporally with the first descriptions of pertussis outbreaks in Europe in the 16th century. We found little evidence of recent geographical clustering of the strains within this lineage, suggesting rapid strain flow between countries. We observed that changes in genes encoding proteins implicated in protective immunity that are included in ACVs occurred after the introduction of WCVs but before the switch to ACVs. Furthermore, our analyses consistently suggested that virulence-associated genes and genes coding for surface-exposed proteins were involved in adaptation. However, many of the putative adaptive loci identified have a physiological role, and further studies of these loci may reveal less obvious ways in which B. pertussis and the host interact. This work provides insight into ways in which pathogens may adapt to vaccination and suggests ways to improve pertussis vaccines.

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“…We also assessed the SNP density in gene categories based on Bvg regulation (26, 27). For this, three categories were defined: genes activated, repressed, or unaffected by Bvg (Fig.…”

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination

Bart

Harris

Advani

et al. 2014

mBio

253

350

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“…As a result there exists a dynamic system with a predictable outcome. However, cultivation processes are liable to all kinds of variations that can influence the large number of simultaneous reactions and processes (Streefland et al, 2007). These variations can strongly influence the processes in a negative manner, leading to unpredictable behavior.…”

Section: Introductionmentioning

confidence: 99%

Manufacturing Vaccines: An Illustration of Using PAT Tools for Controlling the Cultivation ofBordetella pertussis

Sprang¹,

Streefland

Ramaker³

et al. 2007

Quality Engineering

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An illustration of the operational consistency of the upstream part of a biopharmaceutical process is given. For this purpose four batch cultivations of Bordetella pertussis have been executed under identical conditions. The batches have been monitored by means of two fundamentally different process sensors. First, common single channel measurements such as temperature, pH, dissolved oxygen (DO), and flow rates are used and second, the multichannel measurements from the NIR (Near Infrared) analyzer. Because of the fundamental differences between the two types of measurements, two models have been developed to evaluate the operational consistency. The last sensor studied is a typical representative of process analyzers which are described in the PAT (Process Analytical Technology) guidance document issued in 2004 by the American Food and Drug Administration (FDA). Data from both sensors have been evaluated by a multivariate tool for data acquisition. This resulted in two different performance models. Again this approach is characteristic for the implementation of PAT for the manufacture of biopharmaceuticals.With both performance models, we were able to explore the operational consistency of the batches. In addition, the performance models were also able to detect a deviating batch. Further, it was shown that both sensor types gave partly overlapping information since a deviation in the batch profiles of the logged process variables was accompanied by a deviation in the spectral batch profiles.The performance models are valuable tools in developing advanced monitoring and control systems for biopharmaceutical processes. Using such models, advanced knowledge based systems can be developed to detect abnormal situations in an early stage and remove the cause.The procedure of data processing described in this article is relatively new in the biopharmaceutical industry. The NIR analyzer and both performance models presented in this article are clear ingredients for better process understanding and process control, as intended in the FDA's PAT Initiative. This initiative is part of the FDA's strategy of cGMP (current good manufacturing practice) for the 21st century and aims at introducing innovations Address correspondence to Eric N. M. van Sprang, in both the manufacturing of biopharmaceuticals and the development of new biopharmaceuticals.This study shows the feasibility of two typical PAT tools for controlling the manufacturing of biopharmaceuticals. To the best of our knowledge such feasibility study is not documented up to now in the scientific literature.

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“…From a regulatory perspective, Process Analytical Technology (PAT) is an important initiative that can be applied to many types of vaccine processes [24]. For example, PAT has been successfully used to increase the robustness of the production protocol for the whole-cell whooping cough vaccine [25,26].…”

Section: Discussionmentioning

confidence: 99%

Method for the simultaneous assay of the different poliovirus types using surface plasmon resonance technology

Manin

Naville

Gueugnon

et al. 2013

Vaccine

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PAT for vaccines: The first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease

Cited by 31 publications

References 16 publications

Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination

Global Population Structure and Evolution of Bordetella pertussis and Their Relationship with Vaccination

Manufacturing Vaccines: An Illustration of Using PAT Tools for Controlling the Cultivation ofBordetella pertussis

Method for the simultaneous assay of the different poliovirus types using surface plasmon resonance technology

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