Practical Approaches to Forced Degradation Studies of Vaccines

Hasija, Manvi; Aboutorabian, Sepideh; Rahman, Nausheen; Ausar, Salvador F.

doi:10.1007/978-1-4939-3387-7_49

Cited by 4 publications

(3 citation statements)

References 13 publications

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“…The process of FD studies is a science unto itself and is beyond the scope of this chapter. We therefore refer the reader to excellent reviews on the topic when deciding what stress condition(s) are most appropriate for their vaccine of interest [9,11]. For thermal stress, as described for RiCoE, ensure that the oven or incubator is sufficiently humidified to avoid desiccation of samples.…”

Section: Methods Of Forced Degradation (Fd)mentioning

confidence: 99%

“…To establish the relationship between RiVax in vivo potency and in vitro reactivity by RiCoE, it is necessary to compare native, partially degraded, and fully degraded vaccine preparations sideby-side. So-called forced degradation (FD) studies can be conducted under a variety of conditions based on the intrinsic biochemical/biophysical properties of the antigen being studied [8,9]. In the case of RiVax, it has been established that thermal stress irreversibly denatures the antigen [10].…”

Section: Force Degradation (Fd) Studiesmentioning

confidence: 99%

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Estimating Vaccine Potency Using Antibody-Based Competition Assays

et al. 2021

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The issues of vaccine potency and stability constitute formidable challenges associated with the development and readiness of vaccines for biodefense. In most instances, the vaccines will be stockpiled (at considerable cost) for years and used only in the rare event of a public health emergency. It is therefore imperative that there be means to readily monitor overall stability of the stockpiled vaccines, preferably using reliable in vitro assays, without the need for expensive and labor-intensive animal studies. In this chapter, we describe an in vitro monoclonal antibody-based competition ELISA known as RiCoE for assessing the potency of a ricin toxin subunit vaccine. RiCoE can be applied to drug substance and drug products adsorbed to aluminum salts adjuvant. While RiCoE is specific for ricin toxin, the general methodologies and protocols described herein are amenable to virtually any subunit or even virus-like particle-based vaccine. Ultimately, RiCoE-like assays may replace or at least reduce the need for animal studies in vaccine potency determinations.

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Section: Methods Of Forced Degradation (Fd)mentioning

confidence: 99%

Section: Force Degradation (Fd) Studiesmentioning

confidence: 99%

Estimating Vaccine Potency Using Antibody-Based Competition Assays

et al. 2021

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“…This guidance refers to well-defined polypeptides and proteins, their products, and derivatives that are isolated from body fluids, tissues, cell cultures, or developed using r-DNA technology. The document thus includes the development and submission of stability information for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumor necrosis factors), erythropoietin's, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulin's, monoclonal antibodies, and vaccines consisting of well-characterized proteins or polypeptides [39,40].…”

Section: Q5c: Stability Testing Of Biotechnological/biological Productsmentioning

confidence: 99%

A Review on Stability Testing Guidelines of Pharmaceutical Products

Zothanpuii¹,

Rekapalli²,

Selvakumar³

2020

Asian J Pharm Clin Res

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Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

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Antibody Profiles Elicited by Potent and Subpotent Whole Cell Pertussis Vaccines in Mice

Adewunmi,

Doering,

Kumar

et al. 2024

Preprint

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Inactivated, whole cell pertussis (wP) vaccines remain at the frontline in the global fight against the resurgence of whooping cough, especially in low- and middle-income countries. However, the reliance on the intracerebral mouse potency test (ic-MPT or Kendrick assay) as the standard batch release assay is challenging for the production of commercial wP vaccines. The ic-MPT is technically challenging, labor intensive and, arguably, incongruous with modern animal welfare guidelines. Replacing the ic-MPT with a whole cell Bordetella pertussis ELISA, the so-called pertussis serology potency test (PSPT), has shown promise, but has been difficult to implement in practice. In this report, we tested the hypothesis that potent and subpotent wP vaccines have distinct serologic profiles in mice that could be developed as a substitute for the ic-MPT. We first established an accelerated decay (thermal stress) protocol in which wP, in the context of DTwP, was rendered >10-fold less effective than unstressed vaccine when evaluated in a mouse model of B. pertussis lung clearance following intranasal challenge. We then screened immune sera on a limited B. pertussis Tahoma I proteome array and identified >30 antigens whose antibody reactivity profiles increased, decreased or were unchanged as a function of wP potency. Interestingly, virtually all the indicator antigens identified are known virulence factors or reactive with human convalescent sera, thereby establishing a potential link between wP potency and pertussis infection and immunity. These results bode well for the development of a limited B. pertussis antigen array as a stability-indicating surrogate potency assay for the ic-MPT.

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Practical Approaches to Forced Degradation Studies of Vaccines

Cited by 4 publications

References 13 publications

Estimating Vaccine Potency Using Antibody-Based Competition Assays

Estimating Vaccine Potency Using Antibody-Based Competition Assays

A Review on Stability Testing Guidelines of Pharmaceutical Products

Antibody Profiles Elicited by Potent and Subpotent Whole Cell Pertussis Vaccines in Mice

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