T/CVDA 2-2023 Active Group standards

T/CVDA 2-2023 Animal vaccine composite liposome adjuvant (YSK M103)

Publish Date: 2024-02-01 Implement Date: 2024-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CVDA 2-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Veterinary drugs and livestock farming, veterinary equipment

ICS Name: Veterinary medicine

Publish Date: 2024-02-01

Implement Date: 2024-02-01

Scope

Scope: This standard specifies the technical requirements, testing methods, inspection rules, labeling, storage, transportation, and shelf life of animal vaccine compound liposome adjuvant (YSK M103). This standard applies to the processing, storage, and use of animal vaccine compound liposome adjuvant (YSK M103); Main technical content: An adjuvant is a substance that can nonspecifically modify or enhance the immune response to an antigen when injected into an animal before or simultaneously with the antigen, thereby enhancing the immune effect. Vaccine adjuvants can increase the antigen's surface area, prolong its residence time in the body, enhance the presentation efficiency of antigen-presenting cells, and stimulate the proliferation and differentiation of lymphocytes, thereby improving the protective effect of the vaccine and extending its protection period. 3.2 Liposomes Liposomes are multilayer microcapsules composed of phospholipids and cholesterol dispersed in water, with a diameter of typically 25–500 nm. They have a structure similar to the cellular bilayer and the ability to bind to cells, allowing antigens to be encapsulated and used as antigen carriers. 3.3 Compound Liposome Adjuvant Compound liposome adjuvant is prepared using phospholipids as the main component, combined with high-purity immunologically active substances (such as polysaccharides). As an antigen delivery vehicle, liposome adjuvant binds to target cells and transports antigens specifically to them, thereby enhancing the body's humoral and cellular immune responses and improving the vaccine's immunogenicity. 4 Abbreviations The following abbreviations are applicable to this standard: pH: Acidity (pondus hydrogenii) min: Minute rpm: Revolutions per minute bar: Bar PBS: Phosphate buffered saline nm: Nanometer cP: Centipoise w: Weight ml: Milliliter L: Liter ℃: Degree Celsius 5 Quality Requirements 5.1 Basic Requirements The facilities, raw ma