A spray freeze dried micropellet based formulation proof-of-concept for a yellow fever vaccine candidate

Clénet, Didier; Hourquet, Véronique; Woinet, Bertrand; Ponceblanc, H.; Vangelisti, Manuel

doi:10.1016/j.ejpb.2019.07.008

Cited by 17 publications

(10 citation statements)

References 31 publications

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“…Two-step profiles are often mentioned to describe complex bioproduct degradations with an initial rapid drop followed by a long gradual decrease phase. This is especially the case for viruses such as measles [ 5 ], a vero cell-adapted rinderpest vaccine [ 6 ], canine distemper poultry infectious bronchitis viral vaccines [ 7 ], Rabies [ 3 ], Polio, Yellow fever [ 8 ], and ALVAC poxvirus [ 9 ]. These models not only provide an adequate description of the data at hand, but can also be used to predict values after prolonged times.…”

Section: Methodsmentioning

confidence: 99%

Use of Stability Modeling to Support Accelerated Vaccine Development and Supply

Campa¹,

Pronce

Paludi³

et al. 2021

Vaccines

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Stability assessment of pharmaceuticals in specific storage and shipment conditions is a key requirement to ensure that safe and efficacious products are administered to patients. This is particularly relevant for vaccines, with numerous vaccines strictly requiring cold storage to remain stable. When stability evaluation is exclusively based on real-time data, it may represent a bottleneck for rapid and effective vaccine access. Stability modeling for vaccines represents a key resource to predict stability based on accelerated stability studies; nevertheless, this approach is not fully exploited for these kinds of products. This is likely because of the complexity and diversity of vaccines, as well as the limited availability of dedicated guidelines or illustrative case studies. This article reports a cross-company perspective on stability modeling for vaccines. Several examples, based on the direct experience of the contributors, demonstrate that modeling approaches can be highly valuable to predict vaccines’ shelf life and behavior during shipment or manipulation. It is demonstrated that modeling methodologies need to be tailored to the nature of the vaccine, the available prior knowledge, and the monitored attributes. Considering that the well-established strategies reported in ICH or WHO guidelines are not always broadly applicable to vaccines, this article represents an important source of information for vaccine researchers and manufacturers, setting the grounds for further discussion within the vaccine industry and with regulators.

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Section: Methodsmentioning

confidence: 99%

Use of Stability Modeling to Support Accelerated Vaccine Development and Supply

Campa¹,

Pronce

Paludi³

et al. 2021

Vaccines

Self Cite

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“…The viscerotropism and neurotropism assessments in A129 mice were performed at Sanofi Pasteur with the vYF candidates at pMSL stage, and repeated with the ‘optimal’ vaccine candidate at MSL and WSL stages, and at CITox Lab (Evreux, France) with phase I DS. A129 mice (n = 12) aged 7–9 weeks (B&K Universal) were inoculated subcutaneously with dilution buffer or with 4 times the logarithmic value of 50% cell culture infectious dose (LogCCID 50 ) of Stamaril, YF-VAX or the vYF candidate in 0.4% sodium chloride (NaCl) and 2.5% human serum albumin (HSA) diluent (vaccine candidates at pMSL stage, and ‘optimal’ vaccine candidate at MSL and WSL stages) or in a candidate stabilizing buffer (‘optimal’ vaccine candidate at phase I DS) [23] . The mice were monitored for 11 days to observe clinical signs and score their severity on a four-point scale (0 to 3) as described below.…”

Section: Methodsmentioning

confidence: 99%

“…The immuno-efficacy studies in Syrian Golden hamsters ( Mesocricetus auratus ) were performed at Sanofi Pasteur with the vYF candidates at pMSL stage, and repeated with the ‘optimal’ candidate at the MSL and WSL stages, and at Voxcan (Dommartin, France) with phase I DS. Hamsters (n = 15) aged 4–5 weeks (Janvier Labs) were inoculated subcutaneously with dilution buffer or with 5 LogCCID 50 of Stamaril, YF-VAX or the vYF candidate diluted in 0.4% NaCl and 2.5% HSA diluent (immunogenicity evaluation of vaccine candidate at MSL and WSL stages) or in vYF stabilizing buffer (immunogenicity evaluation of phase I DS) [23] . YF neutralizing antibodies were measured with µPRNT 50 on D26 and D44 post-vaccination (i.e.…”

Section: Methodsmentioning

confidence: 99%

Next generation live-attenuated yellow fever vaccine candidate: Safety and immuno-efficacy in small animal models

Piras-Douce

Raynal

Raquin

et al. 2021

Vaccine

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Highlights vYF-247 was cloned from YF-VAX and adapted for growth in serum-free Vero cells. vYF-247 selected by safety/immunogenicity/efficacy criteria in small animal models. vYF-247 was less neurovirulent than Stamaril and YF-VAX. vYF-247 had similar attenuation profile, viscerotropism, neurotropism and immunogenicity to YF-VAX. vYF-247 protects hamsters from lethal challenge with yellow fever Jimenez P10 virus.

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“…Indeed, such higher reaction orders have often been observed for other biologicals, such as antibodies and vaccines under specific conditions, e.g., Refs. [34][35][36][37]51,52].…”

Section: Name Formulation Packaging Materials (Pm) Corresponding Kine...mentioning

confidence: 99%

“…Instead, various one-step or two-step models are screened and scored [34]. The derived models showed accurate predictions of long-term stability of complex biopharmaceutics such as vaccines [35][36][37][38][39]. Furthermore, these kinetic models can also be used to predict the effect of temperature excursions and the quality of products in real time during their shipments [40].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling

2022

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A crucial aspect of pharmaceutical development is the demonstration of long-term stability of the drug product. Biopharmaceuticals, such as proteins or peptides in liquid formulation, are typically administered via parental routes and should be stable over the shelf life, which generally includes a storing period (e.g., two years at 5 °C) and optionally an in-use period (e.g., 28 days at 30 °C). Herein, we present a case study where chemical degradation of SAR441255, a therapeutic peptide, in different formulations in combination with primary packaging materials was analyzed under accelerated conditions to derive long-term stability predictions for the recommended storing conditions (two years at 5 °C plus 28 days at 30 °C) using advanced kinetic modeling. These predictions served as a crucial decision parameter for the entry into clinical development. Comparison with analytical data measured under long-term conditions during the subsequent development phase demonstrated a high prediction accuracy. These predictions provided stability insights within weeks that would otherwise take years using measurements under long-term stability conditions only. To our knowledge, such in silico studies on stability predictions of a therapeutic peptide using accelerated chemical degradation data and advanced kinetic modeling with comparisons to subsequently measured real-life long-term stability data have not been described in literature before.

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A spray freeze dried micropellet based formulation proof-of-concept for a yellow fever vaccine candidate

Abstract: Graphical abstract

Cited by 17 publications

References 31 publications

Use of Stability Modeling to Support Accelerated Vaccine Development and Supply

Use of Stability Modeling to Support Accelerated Vaccine Development and Supply

Next generation live-attenuated yellow fever vaccine candidate: Safety and immuno-efficacy in small animal models

Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling

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