Home About us Products and Services Quality Assurance Research News Contact Us


REGULATORY TESTING OF VACCINES, CELL-CULTURE DERIVED THERAPEUTICS AND CALF SERUM


International Licensing Authorities stipulate cultural testing of vaccines and biologicals for the absence of mycoplasmas as, when properly applied, this is the most sensitive method for detecting mycoplasma contamination. However, conventional mycoplasma media do not support the growth of M. hyorhinis cultivar α , a cell culture contaminant. Consequently, some Regulatory Protocols require an additional DNA staining test after co-cultivation with a stable cell line.

A list of routinely applied Regulatory Tests is given here but this is not exhaustive and individual tests can be designed where, for instance, compliance with different Regulatory protocols are required within a single test. Where samples arise from outside the UK, several Importation Licences have been successfully obtained from MAFF and applications concerning veterinary vaccines would be made without delay.

Mycoplasma Experience uses media which do support the growth of these fastidious organisms allowing us to offer a more sensitive cultural test than one using conventional media. Please see the regulatory tests that we offer for more information.

Current price list


QUALITY CONTROL

All media lots used in a Regulatory Test are validated with low numbers of low-passage isolates of the organisms stipulated in the Test Protocol. (For example, M. hyopneumoniae and U. urealyticum for EP 2014 : 8.0 MYCOPLASMAS Test used for Non-Avian Mycoplasmas and Ureaplasmas). M. hyorhinis cultivar α (porcine origin, cell culture isolate - ATCC 29052) and M. orale (human throat commensal, cell culture isolate) are always included for mycoplasma media lot validation as these two species are common cell culture contaminants.

Liquid and solid mycoplasma media formulations and their constituent batches are screened for their ability to support the growth of at least seven mycoplasma species before acceptance for use in Regulatory Tests.

Our quality control strains are all low-passage, some being chosen for their exacting growth requirements.

Copies of the documents used to record test progress and the quality control of media lots will be included with the final report.

The guidelines of Good Laboratory Practice are followed in all aspects of our work.