Vaccine, Serum and Cell Culture Testing

Regulatory Testing of Vaccines, Cell-Culture Derived Therapeutics and Calf Serum

The focus of Mycoplasma Experience testing is sensitive cultural testing  for the detection of viable mycoplasmas - and ureaplasmas where required.

A list of routinely applied Regulatory Tests is given 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. The cost of tests includes temperature controlled transport by courier in pre-packaged containers (see packing directions for wet ice and solid carbon dioxide transport) within the UK.

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.

Serum presents a possible source of mycoplasma contamination when used as a cell-culture medium supplement.

CELL CULTURE TESTING

Two cultural tests are offered, a cell-culture test and a cell-screen test. In both tests our uniquely sensitive media (see media lot test sheet) is used but the cell-culture test has a larger inoculum volume, longer test period and copies of the test work-sheet and media lot validation forms are issued (for GLP purposes).

For low-temperature cell cultures - insect, plant or fish - we include an additional low-temperature set of quality control organisms. Testing is performed in parallel at 36 ± 1ºC and at the cell-culture optimum growth temperature (see media lot test sheet.LT)

Sample collection and temperature controlled transport is an integral part of this service (see packing instruction for wet ice and solid carbon dioxide transportation).

CELL CULTURE CONTAMINATION -

SUPPORT SERVICES

We have encountered M. hyorhinis contamination in cell-cultures issued as mycoplasma-free (1997 & 1999) and an isolation from a vaccine seed is shown.

To Laboratories wishing to review existing procedures with the aim of eliminating mycoplasma contamination, we can offer Laboratory Inspection or a lecture from a visiting speaker for staff education.

Cell culture isolations from other laboratories may be submitted for attempted identification against our bank of antisera to common contaminants.

Where a unique cell-culture is found to be contaminated we can offer Eradication based upon antibiotic plus specific antiserum treatment inclusive of in process and final mycoplasma testing coincident with storage of mycoplasma-free stocks.

Mycoplasma Experience