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Veterinary Vaccine Quality Control
BioVenic provides stringent quality control for the development and production of your veterinary vaccines. These control measures aim to monitor, assess, and maintain the quality of veterinary vaccine research and development to ensure consistent high quality and performance of veterinary vaccines from lab-scale production to large-scale production.
Our Services
Raw Material Control
- Physicochemical Tests
BioVenic employs specific tests to assess the quality and stability of raw materials for veterinary vaccine manufacturing, based on the nature of these materials.
| Vaccine Types | Assays |
|---|---|
| Liquid Veterinary Vaccines | The pH value. |
| Veterinary Vaccines Containing Adjuvants | Assessments of properties such as emulsification, viscosity, and color. |
| Inactivated Veterinary Vaccines | Residual level testing for agents used in pathogen inactivation and other residual organic solvents. |
- Biological Tests
The manufacturing process of veterinary vaccines is susceptible to various factors, and its composition is complex, often making terminal sterilization unfeasible.
| Assays | Description |
|---|---|
| Sterility Testing | Checking for the presence of viable microorganisms other than the vaccine strain through traditional direct inoculation or membrane filtration methods. |
| Mycoplasma Testing | Culture-based, DNA staining, and PCR methods. |
- Sterilization
Some biological components, such as the pathogen components in attenuated vaccines, cannot undergo final sterilization. For components like growth media or other constituents in veterinary vaccine components, BioVenic provides final sterilization through methods such as heat. Furthermore, the sterilization services also extend to sterilization through ionizing radiation, exposure to ethylene oxide (or other suitable gaseous sterilizing agents), or sterile filtration into aseptic containers.
Seed Lot System Establishment
The manufacturing of veterinary vaccines should be based on a seed lot system. The seed lot system provides assurance of continuous production, safety, and purity of the final product, and offers the advantage of allowing for safety and efficacy assays to be conducted on each batch of vaccine. BioVenic establishes strict quality control for both master seed and working seed lot systems.
- Characterization
BioVenic provides characterization services for various types of seed lots, including cell banks, virus seed lots, and bacterial seed lots.
| Assays | Description |
|---|---|
| Cell Banks | Tumorigenic phenotype, expression of endogenous viruses, growth characteristics, and genetic stability of the cells. |
| Viruses | The sequencing and genetic stability of vaccine virus strains, as well as the assessment of their tissue tropism, temperature sensitivity, and attenuation properties. |
- Sterility Testing
The BioVenic offers sterility testing services to ensure that there are no visible live contaminating microorganisms in seed lots.
| Assays | Description |
|---|---|
| Direct Inoculation | Inoculated directly into the culture medium and in-process and final observations are made during the testing cycle in order to detect aerobic and anaerobic microorganisms. |
| Membrane Filtration |
Passed through a filter membrane and then warmed in culture medium. Filtration washes away components of the sample that may cause turbidity or inhibit microbial growth, such as antibiotics or preservatives. |
- Identify Testing
BioVenic provides identity testing for viral and bacterial seed lots, which must be certified as containing only the viral or bacterial species and strains described.
In-Process Testing
It is necessary to control bioburden, virus contamination, and endotoxin production during veterinary vaccine manufacturing, based on the source of raw materials, manufacturing processes, and their intended use. Therefore, BioVenic establishes appropriate controls at all stages of production to ensure the quality of intermediates and raw materials.
- Inactivation Validation
For inactivated veterinary vaccines, precautionary measures must be taken to prevent potential viral contamination during both pre-inactivation and post-inactivation steps. Additionally, to ensure the completion of pathogen inactivation, BioVenic provides inactivation validation services.
| Types | Assays |
|---|---|
| Bacterial Veterinary Vaccines | At least two passages in an appropriate solid or liquid medium and monitoring for abnormal toxicity in animals. |
| Viral Veterinary Vaccines | At least two passages in cells, embryonated eggs, or animals. |
- Endotoxin Detection
Endotoxins are relatively insoluble substances found in the outer membrane of Gram-negative bacterial cell walls. Their primary component is lipopolysaccharide, which is released when bacteria die or lyse. When present in vaccines, endotoxins can potentially cause adverse reactions in vaccinated animals, interacting with the immune system and significantly impacting animal health.
To ensure the safety and efficacy of veterinary vaccines, BioVenic offers endotoxin detection services. We use Limulus amebocyte lysate to specifically detect endotoxins in veterinary vaccines, which may be present, and determine their concentration through a specific gel reaction.
Fig.1 The Reaction of Endotoxins and β–Glucans with Limulus Amebocyte Lysate Reagents. 1
Why Choose Us?
- Covering the entire veterinary vaccine production process, strict quality control links.
- Offering stable results and controllable quality in quality control testing.
- The testing meets the relevant requirements and ensures a high level of quality in veterinary vaccines, which includes comprehensive testing of vaccine pH, adjuvant properties, pathogen inactivators and residual organic solvents.
As a vital means for animals to defend against diseases and maintain their health, the quality of veterinary vaccines must meet high standards. Vaccines should provide animals with safe immunization without causing adverse reactions. Therefore, maintaining high-quality veterinary vaccines should begin with the raw materials. BioVenic ensures strict quality control throughout the entire manufacturing process of your veterinary vaccines, preventing the intrusion of foreign substances from all aspects while guaranteeing their original quality. If you're interested in the production and quality control of veterinary vaccines, please don't hesitate to contact us now!
Reference
- Lawniczek-Walczyk, Anna, and Rafał L. Górny. "Endotoxins and beta-glucans as markers of microbiological contamination-characteristics, detection, and environmental exposure." Annals of Agricultural and Environmental Medicine 17.2 (2010): 193-208.