Next Article in Journal
Seaweed-Based Products and Mushroom β-Glucan as Tomato Plant Immunological Inducers
Next Article in Special Issue
Shortening the Lipid A Acyl Chains of Bordetella pertussis Enables Depletion of Lipopolysaccharide Endotoxic Activity
Previous Article in Journal
Dendritic Cells and Myeloid Derived Suppressor Cells Fully Responsive to Stimulation via Toll-Like Receptor 4 Are Rapidly Induced from Bone-Marrow Cells by Granulocyte-Macrophage Colony-Stimulating Factor
Previous Article in Special Issue
The Role of Virulence Proteins in Protection Conferred by Bordetella pertussis Outer Membrane Vesicle Vaccines
Open AccessArticle

Manufacture of a Stable Lyophilized Formulation of the Live Attenuated Pertussis Vaccine BPZE1

1
ILiAD Biotechnologies, New York, NY 10003, USA
2
Centre d’Infection et d’Immunité de Lille, Univ. Lille, CNRS, Inserm, CHU Lille, Institute Pasteur de Lille, U1019–UMR9017–CIIL–Center for Infection and Immunity of Lille, F-59000 Lille, France
*
Author to whom correspondence should be addressed.
Vaccines 2020, 8(3), 523; https://doi.org/10.3390/vaccines8030523
Received: 18 August 2020 / Revised: 7 September 2020 / Accepted: 11 September 2020 / Published: 13 September 2020
(This article belongs to the Special Issue Next-Generation Pertussis Vaccines)
Current pertussis vaccines protect against disease, but not against colonization by and transmission of Bordetella pertussis, whereas natural infection protects against both. The live attenuated vaccine BPZE1 was developed to mimic immunogenicity of natural infection without causing disease, and in preclinical models protected against pertussis disease and B. pertussis colonization after a single nasal administration. Phase 1 clinical studies showed that BPZE1 is safe and immunogenic in humans when administered as a liquid formulation, stored at ≤−70 °C. Although BPZE1 is stable for two years at ≤−70 °C, a lyophilized formulation stored at ≥5 °C is required for commercialization. The development of a BPZE1 drug product, filled and lyophilized directly in vials, showed that post-lyophilization survival of BPZE1 depended on the time of harvest, the lyophilization buffer, the time between harvest and lyophilization, as well as the lyophilization cycle. The animal component-free process, well defined in terms of harvest, processing and lyophilization, resulted in approximately 20% survival post-lyophilization. The resulting lyophilized drug product was stable for at least two years at −20 °C ± 10 °C, 5 °C ± 3 °C and 22.5 °C ± 2.5 °C and maintained its vaccine potency, as evaluated in a murine protection assay. This manufacturing process thus enables further clinical and commercial development of BPZE1. View Full-Text
Keywords: pertussis; live attenuated vaccine; lyophilization; vaccine stability pertussis; live attenuated vaccine; lyophilization; vaccine stability
Show Figures

Figure 1

MDPI and ACS Style

Thalen, M.; Debrie, A.-S.; Coutte, L.; Raze, D.; Solovay, K.; Rubin, K.; Mielcarek, N.; Locht, C. Manufacture of a Stable Lyophilized Formulation of the Live Attenuated Pertussis Vaccine BPZE1. Vaccines 2020, 8, 523.

Show more citation formats Show less citations formats
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Search more from Scilit
 
Search
Back to TopTop