Veterinary products encompass a large number of drugs aiming to protect pets and livestock for human food.
Besides the use of antibiotics, vaccines are crucial to prevent diseases in animals. Thus, veterinary industry has developed and is still developing new virus-based vaccines.
As per human vaccination, it is necessary to ensure the safety of the product. For this purpose and as usual when talking about viral vaccines, two elements must be considered: the virus strain on one hand and the production factory – the cell line – on another hand.
In both cases, according to international guidelines (EP, FDA), strategy of testing must be based on the origin of the material and the species targeted by the vaccines.
Through a long history with the animal health vaccine industry, Clean Cells has built a strong portfolio of vaccine dedicated services supported by its GMP license and extensive knowledge of regulations that apply in the veterinary field.
The company offers a wide range of services for viral vaccine manufacturer, including cell bank production and storage, characterization and quality control.
Thanks to more than 20 years in the field of vaccine manufacturing, Clean Cells has experience working with adherent or non-adherent cell lines, mammalian, insect, avian cell lines and related viruses.
Clean Cells is able to support the manufacturing and the quality control of cell banks and virus banks in GMP grade to ensure and efficient development process of vaccines.
Clean Cells is an established expert in biosafety testing in the veterinary field with a proven cGMP track record as part of its vaccine related services. Our company has many permissive cellular models for a non-specific (agnostic) detection of contaminants. Clean Cells’ team has also developed and validated a unique worldwide panel of PCR assays applicable to animal health vaccines.
Recommendations for the testing of Viral vaccines are Regulatory frameworks for the testing of veterinary vaccine products are provided by competent authorities, including FDA requirement and the comprehensive list of the EDQM (European Pharmacopoeia, i.e EP §5.2.4 and 5.2.5).
According to regulatory evolutions and requirements, or specificity of the developed vaccines themselves bespoke services, including analytical development solutions such as PCR targeting a specific virus may be required.
Thanks to its great expertise in cell and molecular biology, and its perfect knowledge of regulations, Clean Cells offers support to develop and validate specific quality control tools in accordance with cGMP expectations and worldwide regulations (ICHQ2).
Since cell and virus banks are valuable items in the process of producing vaccines, Clean Cells proposes additional services, including cell bank storage and virus bank storage solutions for the preservation of R&D and GMP material.
This storage activity is fully secured through a 24/7 surveillance of storage spaces and complete back-up systems and power supply.
Please reach out for the full detail of vaccine related services applicable to your product.
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