Use of immuno assays during the development of a<i>Hemophilus influenzae</i>type<i>b</i>vaccine for technology transfer to emerging vaccine manufacturers

Hamidi, Ahd; Kreeftenberg, Hans

doi:10.4161/hv.29300

Cited by 6 publications

(7 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Hib PRP antigens were conjugated to TT, and ELISA used to assess if the PRP was pure and if the two components were successfully linked. It was found that ELISA was suitably precise and cheap for use as a test by others for similar purposes (Hamidi & Kreeftenberg, 2014).…”

Section: Conjugate Productionmentioning

confidence: 99%

Glycoconjugate vaccines: some observations on carrier and production methods

MacCalman

Phillips‐Jones

Harding

2019

Biotechnology and Genetic Engineering Reviews

View full text Add to dashboard Cite

Glycoconjugate vaccines use protein carriers to improve the immune response to polysaccharide antigens. The protein component allows the vaccine to interact with T cells, providing a stronger and longer-lasting immune response than a polysaccharide interacting with B cells alone. Whilst in theory the mere presence of a protein component in a vaccine should be sufficient to improve vaccine efficacy, the extent of improvement varies. In the present review, a comparison of the performances of vaccines developed with and without a protein carrier are presented. The usefulness of analytical tools for macromolecular integrity assays, in particular nuclear magnetic resonance, circular dichroism, analytical ultracentrifugation and SEC coupled to multi-angle light scattering (MALS) is indicated. Although we focus mainly on bacterial capsular polysaccharideprotein vaccines, some consideration is also given to research on experimental cancer vaccines using zwitterionic polysaccharides which, unusually for polysaccharides, are able to invoke T-cell responses and have been used in the development of potential all-polysaccharide-based cancer vaccines.A general trend of improved immunogenicity for glycoconjugate vaccines is described. Since the immunogenicity of a vaccine will also depend on carrier protein type and the way in which it has been linked to polysaccharide, the effects of different carrier proteins and production methods are also reviewed. We suggest that, in general, there is no single best carrier for use in glycoconjugate vaccines. This indicates that the choice of carrier protein is optimally made on a case-by-case basis, based on what generates the best immune response and can be produced safely in each individual case.

show abstract

Section: Conjugate Productionmentioning

confidence: 99%

Glycoconjugate vaccines: some observations on carrier and production methods

MacCalman

Phillips‐Jones

Harding

2019

Biotechnology and Genetic Engineering Reviews

View full text Add to dashboard Cite

show abstract

“…That was also the case for residual reagents and residual reactive groups, initially nuclear magnetic resonance (NMR) was used but these tests can also be omitted after process validation. The identity of each bulk conjugate was tested using the antigenicity test . To test for the immunogenicity of the bulk conjugate, a mice immunogenicity test, was developed …”

Section: Development Strategy Followed For the New Hib Conjugate Vaccinementioning

confidence: 99%

“…The identity of each bulk conjugate was tested using the antigenicity test . To test for the immunogenicity of the bulk conjugate, a mice immunogenicity test, was developed …”

Section: Development Strategy Followed For the New Hib Conjugate Vaccinementioning

confidence: 99%

“…The final lot was tested for total polysaccharide, free polysaccharide, sterility, molecular weight, pH, residual moisture, identity, and endotoxin. During process validation, the final lot was tested on immunogenicity, general safety and specific toxicity to tetanus…”

Section: Development Strategy Followed For the New Hib Conjugate Vaccinementioning

confidence: 99%

“…Harvesting at a pH > 7.6 will result in a higher yield of polysaccharide due to cell lysis, but also in more contaminants such as cell debris, endotoxin and proteins, complicating the purification of the crude polysaccharide. For the determination of PRP concentration during the cultivation process the PRP‐Elisa method was used …”

Section: Development Strategy Followed For the New Hib Conjugate Vaccinementioning

confidence: 99%

See 2 more Smart Citations

Process development of a New Haemophilus influenzae type b conjugate vaccine and the use of mathematical modeling to identify process optimization possibilities

Hamidi

Kreeftenberg

Pol

et al. 2016

Biotechnology Progress

Self Cite

View full text Add to dashboard Cite

Vaccination is one of the most successful public health interventions being a cost-effective tool in preventing deaths among young children. The earliest vaccines were developed following empirical methods, creating vaccines by trial and error. New process development tools, for example mathematical modeling, as well as new regulatory initiatives requiring better understanding of both the product and the process are being applied to well-characterized biopharmaceuticals (for example recombinant proteins). The vaccine industry is still running behind in comparison to these industries. A production process for a new Haemophilus influenzae type b (Hib) conjugate vaccine, including related quality control (QC) tests, was developed and transferred to a number of emerging vaccine manufacturers. This contributed to a sustainable global supply of affordable Hib conjugate vaccines, as illustrated by the market launch of the first Hib vaccine based on this technology in 2007 and concomitant price reduction of Hib vaccines. This paper describes the development approach followed for this Hib conjugate vaccine as well as the mathematical modeling tool applied recently in order to indicate options for further improvements of the initial Hib process. The strategy followed during the process development of this Hib conjugate vaccine was a targeted and integrated approach based on prior knowledge and experience with similar products using multi-disciplinary expertise. Mathematical modeling was used to develop a predictive model for the initial Hib process (the 'baseline' model) as well as an 'optimized' model, by proposing a number of process changes which could lead to further reduction in price. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:568-580, 2016.

show abstract

Polysaccharide conjugate vaccine: A kind of vaccine with great development potential

Zhao

Huang

et al. 2021

Chinese Chemical Letters

View full text Add to dashboard Cite

Use of immuno assays during the development of aHemophilus influenzaetypebvaccine for technology transfer to emerging vaccine manufacturers

Cited by 6 publications

References 15 publications

Glycoconjugate vaccines: some observations on carrier and production methods

Glycoconjugate vaccines: some observations on carrier and production methods

Process development of a New Haemophilus influenzae type b conjugate vaccine and the use of mathematical modeling to identify process optimization possibilities

Polysaccharide conjugate vaccine: A kind of vaccine with great development potential

Contact Info

Product

Resources

About