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Apeldoorn, Netherlands

van de Waterbeemd B.,National Institute for Public Health and the Environment RIVM | Zomer G.,National Institute for Public Health and the Environment RIVM | Kaaijk P.,National Institute for Public Health and the Environment RIVM | Ruiterkamp N.,Bilthoven Biologicals | And 3 more authors.
PLoS ONE | Year: 2013

An improved detergent-free process has been developed to produce vaccine based on native outer membrane vesicles (NOMV) against Neisseria meningitidis serogroup B. Performance was evaluated with the NonaMen vaccine concept, which provides broad coverage based on nine distinct PorA antigens. Scalable aseptic equipment was implemented, replacing undesirable steps like ultracentrifugation, inactivation with phenol, and the use of preservatives. The resulting process is more consistent and gives a higher yield than published reference processes, enabling NOMV production at commercial scale. Product quality met preliminary specifications for 9 consecutive batches, and an ongoing study confirmed real-time stability up to 12 months after production. As the NOMV had low endotoxic activity and induced high bactericidal titres in mice, they are expected to be safe and effective in humans. The production process is not limited to NonaMen and may be applicable for other N. meningitidis serogroups and other gram-negative pathogens. The current results therefore facilitate the late-stage development and clinical evaluation of NOMV vaccines. © 2013 van de Waterbeemd et al. Source


Westdijk J.,Institute for Translational Vaccinology | Koedam P.,Bilthoven Biologicals | Barro M.,Global Vaccines Inc. | Barro M.,Health-U | And 7 more authors.
Vaccine | Year: 2013

Six different adjuvants, each in combination with inactivated polio vaccine (IPV) produced with attenuated Sabin strains (sIPV), were evaluated for their ability to enhance virus neutralizing antibody titres (VNTs) in the rat potency model. The increase of VNTs was on average 3-, 15-, 24-fold with adjuvants after one immunization (serotypes 1, 2, and 3, respectively). Also after a boost immunization the VNTs of adjuvanted sIPV were on average another 7-20-27 times higher than after two inoculations of sIPV without adjuvant. The results indicate that it is feasible to increase the potency of inactivated polio vaccines by using adjuvants. © 2013 Elsevier Ltd. Source


ten Have R.,Institute for Translational Vaccinology | Westdijk J.,Institute for Translational Vaccinology | Levels L.M.A.R.,Bilthoven Biologicals | Koedam P.,Bilthoven Biologicals | And 5 more authors.
Biologicals | Year: 2015

This study addresses observations made in view of testing in practice the guideline in the European Pharmacopoeia (EP) on omitting the rat potency test for release of polio containing vaccines. In general, use of the guideline is valid and the D-antigen ELISA can indeed be used as an in vitro alternative for the in vivo test. However, the set-up of the ELISA is crucial and should include detection of antigenic site 1 in polio serotype 3 as destruction of that site by trypsin results in a reduced rat potency. Antigenic site 1 in polio serotype 2 may also be modified by trypsin, but the cleavage of viral protein 1 (VP1) did not affect the rat potency. Therefore, any antigenic site, except site 1, can be used for detection of polio serotype 2. It is advised to include testing of the effect of trypsin treatment in the EP-guideline. This allows polio vaccine manufacturers to check whether their in-house ELISA needs improvement. © 2015 The International Alliance for Biological Standardization. Source


Ten Have R.,Institute for Translational Vaccinology | Westdijk J.,Institute for Translational Vaccinology | Levels L.M.A.R.,Bilthoven Biologicals | Koedam P.,Bilthoven Biologicals | And 4 more authors.
Biologicals | Year: 2015

This study addresses observations made in view of testing in practice the guideline in the European Pharmacopoeia (EP) on omitting the rat potency test for release of polio containing vaccines. In general, use of the guideline is valid and the D-antigen ELISA can indeed be used as an invitro alternative for the invivo test. However, the set-up of the ELISA is crucial and should include detection of antigenic site 1 in polio serotype 3 as destruction of that site by trypsin results in a reduced rat potency. Antigenic site 1 in polio serotype 2 may also be modified by trypsin, but the cleavage of viral protein 1 (VP1) did not affect the rat potency. Therefore, any antigenic site, except site 1, can be used for detection of polio serotype 2. It is advised to include testing of the effect of trypsin treatment in the EP-guideline. This allows polio vaccine manufacturers to check whether their in-house ELISA needs improvement. © 2015 The International Alliance for Biological Standardization. Source

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