Ensuring Viral Safety of Equine Immunoglobulins during Production.
Abstract: Equine blood plasma/serum and intermediates must be monitored for the presence of live viruses pathogenic in humans during production of equine immunoglobulins. Information concerning low-cost and simple methods for the detection of live horse viruses pathogenic and non-pathogenic to humans was gained using data of modern domestic and foreign literature. These methods are based on cultivation of these viruses on sensitive biosystems. The presented information can be used to set up blood plasma/serum control of horses at different stages of immunoglobulin production, i.e., when taking blood from horses during their quarantine period, when collecting blood from immunized horses, and before bottling the medicinal intermediate in the primary package.
© Springer Science+Business Media, LLC, part of Springer Nature 2022.
Publication Date: 2022-05-07 PubMed ID: 35571872PubMed Central: PMC9076163DOI: 10.1007/s11094-022-02632-zGoogle Scholar: Lookup
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Summary
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The research article discusses about strategies to ensure the absence of live viruses in equine immunoglobulins during production, through simple, low-cost detection methods.
Overview of the Study
- The study presents information on monitoring live viruses in equine blood plasma/serum and intermediates that could be harmful to humans during the production of equine immunoglobulins.
- The focus is on discovering affordable and uncomplicated detection methods for horse viruses that are pathogenic and non-pathogenic to humans.
- The methods revolve around cultivating these viruses on sensitive biosystems and the implications of this information can be crucial in ensuring the purity of immunoglobulin production.
The Importance of Control Stages
- The paper specifies different stages for controlling the blood plasma/serum of horses, each point serving a specific role in ensuring safety in the production process.
- The first stage involves extracting blood from horses during their quarantine period – a precautionary measure to ensure the exclusion of potential virus carriers.
- Next, scientists collect blood from immunized horses. If viruses are detected in these specimens, it could indicate that the horse’s immune system is not resistant to certain viruses, thus posing a risk for the production of equine immunoglobulins.
- The final stage involves testing the medicinal intermediate before it is packed in the primary package. This critical step ensures that no pathogenic viruses have survived the production process, thus guaranteeing the safety of the finished product.
Implications of the findings
- Identifying and integrating affordable and simple detection methods as reported in this paper into the production process can significantly improve the safety of producing equine immunoglobulins.
- Being able to detect both pathogenic and non-pathogenic viruses can ensure the production of viral-free equine immunoglobulins, potentially reducing possible health risks to those receiving these immunoglobulins.
- This research may also serve as a template for similar studies in other areas of biomedicine, broadening the scope of virus detection and prevention during medication production.
Cite This Article
APA
Mashin VV, Sergeev AN, Martynova NN, Oganov MD, Sergeev AA, Kataeva VV, Zagidullin NV.
(2022).
Ensuring Viral Safety of Equine Immunoglobulins during Production.
Pharm Chem J, 56(2), 283-288.
https://doi.org/10.1007/s11094-022-02632-z Publication
Researcher Affiliations
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
- AVVAPharmaceuticals Ltd., Representative Moscow Office, Office 8, 4/3 Aviamotornaya St., Moscow, 111116 Russia.
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
- Microgen Scientific Industrial Company for Immunobiological Medicines JSC, 10 2nd Volkonskii Pereulok, Moscow, 127473 Russia.
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