Monocyte Activation Test for Live Biotherapeutic Products

Creative Biolabs is a professional CRO company that has developed a comprehensive service chain in developing various live biotherapeutic products. With in-depth expertise in pyrogenicity, endotoxin, as well as monocyte activation analysis, we have completed many projects in this field which can help our worldwide customers shorten the development time and can offer the most meaningful data.

Introduction to Monocyte Activation Test

Over the past few decades, a large number of live biotherapeutic products, including next-generation probiotics (NGPs), have been developed for treating various types of human and animal diseases. Meanwhile, a panel of detection systems for live biotherapeutic products have been designed and widely used for measuring the safety, efficacy, and product quality in the pharmaceutical industry.

Among them, the monocyte activation test has been considered as an essential part of the quality control in the process of live biotherapeutic product development. Previous studies have indicated that an in vitro monocyte activation test is designed to test pro-inflammatory cytokines and contaminants in different samples from live biotherapeutic products. In principle, the monocyte samples, such as whole blood sample, or the contaminants will be cultured into ready-to-use cell lines to trigger the activation of CD14 receptors which can help the release of certain endogenous pyrogenic cytokines. Afterward, the readouts of these cytokines, like interleukin-6 (IL-6) and tumor necrosis factor α (TNFα), will be further calculated and analyzed.

Monocyte Activation Test Services. Fig.1 Monocyte Activation Test Services.

Our Services for Monocyte Activation Test

The monocyte activation test is a common method for detecting the pro-inflammatory cytokines and exogenous/endogenous contaminants of live biotherapeutic products. Till now, the monocyte activation test has been regarded as an attractive method for evaluating the adverse reactions caused by microorganisms and other substances in live biotherapeutic products.

Recently, Creative Biolabs is focused on providing rapid and effective solutions in designing, optimizing, and performing a monocyte activation test for various live biotherapeutic products. We pride ourselves on our professional team of novel monocyte activation test assay discovery studies. In our services, you can rely on professional project management, and advanced technologies to help the success of your projects. We can provide you with a comprehensive solution package to guide your projects from the custom design of the monocyte activation test to the kit commercialization of the monocyte activation test.

Methods of Monocyte Activation Test

Nowadays, Creative Biolabs has established a one-stop and ready-to-use monocyte activation test platform that provides animal-free testing systems for a broad spectrum of test articles and substances in live biotherapeutic products. In general, when performing a monocyte activation test, different kinds of samples, such as peripheral blood mononuclear cells (PBMNC), whole blood, or monocytic cells, are exposed in certain tissue cultures to test substances. The cytokines, including IL-1β, IL-6, IL-8, and TNFα, will be detected by an enzyme-linked immunosorbent assay to determine if the samples contain contaminants.

Besides, much effort has been made to optimize animal-free culture conditions and the sensitivity of cytokine detection assays. Our scientists are available to skillfully operate tests and illustrate the results, including whole blood monocyte activation test and PBMNC monocyte activation test, in our certified laboratories.

Correlation between the induction of IL-6 and IL-1β in the cryoWB monocyte activation test system. Fig.2 Correlation between the induction of IL-6 and IL-1β in the cryoWB monocyte activation test system. (de Mattos, 2018)

Why Choose Us?

The main advantages of our monocyte activation test services

  • Well-mature monocyte activation test platform
  • Integrated solution for multiple live biotherapeutic products
  • In vitro assays that meet regulatory compliances
  • High accuracy and high sensitivity: LOD 0.1 EU/mL
  • Rich ready-to-use cell lines

Creative Biolabs is recognized as the world leader for providing the most diverse portfolio of live biotherapeutic product development solutions for worldwide customers. We are always dedicated to assisting our clients with the most satisfactory monocyte activation testing services. We can provide many flexible options, from which you can always find a better match for your particular project. Please feel free to contact us for closer communication to learn how we can be involved in your project. Separate services or integrated end-to-end solutions are all welcomed.

Reference

  1. de Mattos, K. A., et al. Applicability of the monocyte activation test (MAT) in the quality control of the 17DD yellow fever vaccine. Alternatives to Laboratory Animals. 2018, 46(1): 23-37.

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