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UK Health Security Agency

Quality control

The final date for Culture Isolation testing is the 26th of November 2024, for all other tests last submission date is 9th December for growing orders and 6th December for Frozen ampoules.

 

Quality control is a crucial aspect of ensuring the reliability and safety of products and materials. It involves systematic processes and procedures aimed at monitoring and maintaining consistent quality standards throughout production or experimentation. At ECACC, we take pride in our commitment to quality control, offering comprehensive services to support your endeavors.

 

Sterility testing

ECACC offers a sterility testing service; cell lines and cell culture media can be submitted for testing to determine if microbial contamination is present. This is carried out using classical culture techniques, which are compared to positive and negative controls.

 

ECACC isolates bacteria and fungi using two United States Pharmacopeia (USP)/European Pharmacopeia (EP) recommended media:

  • Fluid thioglycollate medium (FTM) for the detection of aerobic and anaerobic bacteria.

  • Tryptose soya broth (TSB) for the detection of aerobes, facultative anaerobes and fungi.

Bacteria and fungi testing by culture to FDA Code of Federal Regulations. Title 21 (610.12)

 

Mycoplasma testing

Mycoplasma are the smallest (0.2 - 2µm in diameter) and most unusual of the prokaryotes.  We can test your cell lines, cell culture media and reagents to determine if mycoplasma is present. The effects of mycoplasma contamination on cell lines can be wide ranging and are often underestimated and can include: 

  • alteration of growth rate

  • induction of morphological changes 

  • chromosomal aberrations

  • altered cell metabolism

  • decreased viability upon resuscitation of frozen ampoule.

  • induction of transformation, apoptosis, cytokines, signal transduction and oxidative radicals

  • macrophage activation

  • inhibition of antigen presentation

In addition, mycoplasma can also interfere with membrane receptor function and penetrate host cells.

All laboratories carrying out cell culture should test for mycoplasma contamination on a regular basis, and we recommend that a combination of methods is used to determine whether a sample is free of mycoplasma.  This is because the different methods have different levels of detection sensitivity and some strains of mycoplasma do not grow in vitro. These can be detected by DNA stain and PCR.

Find out more about Mycoplasma testing here.

 

Price of testing

Name of test

Quality Control

Catalogue number

Price

Sensitivity

Species range

Meets FDA points to consider in   characterisation of cell lines used to produce biologicals (1993)

Bacteria and fungi testing by culture

Sterility testing

ECSR04

£118.45

N/A

N/A

N/A

qPCR

Mycoplasma testing

ECSR33

£125

High

Majority

No

Indirect Hoechst Stain

Mycoplasma testing

ECSR60

£125

Medium

All

Yes

Culture Isolation

Mycoplasma testing

ECSR61

£175

High

Majority

Yes

Sample preparation from frozen ampoule 

Mycoplasma testing

 ECSR30

 £75

 N/A

 N/A

 

N/A

 
 

 

Mycoplasma and sterility testing sample submission 

Please complete and submit a sample submission form here.

Please note that prior approval of QC testing GMO2 samples is required. Please contact culturecollections.quality@ukhsa.gov.uk for more information.

Any biological material can be Mycoplasma and/or sterility tested if it is cell culture compatible. Please complete the Sample Submission form (see below) and the Biohazard Risk Assessment - Cell Lines and send both forms to us prior to arranging shipment of samples. Once the forms have been received, reviewed and accepted by ECACC, you will be issued with a reference number that will need to be quoted in all future correspondence (and on your samples). A Purchase Order number is also required before any sample can be processed.

If sending growing cultures:

  • growing cultures should have been passaged twice in the absence of antibiotics. They should have been growing for three days since the last medium change. ECACC need to be notified of the time of the last medium change so that, if necessary, the minimum growth time in the absence of antibiotics can be completed at ECACC

  • growing cultures should be sent in flasks topped up with medium. The flask cap should be of the non-vented variety and wrapped e.g. in parafilm, to prevent leakage

If sending frozen cultures:

  • a handling fee will be charged to cover costs of establishing the cell lines in culture

  • details of the cell line growth media and culture conditions must be supplied

Flasks and ampoules should be adequately packed and transported according to UN 602 regulations. Approved UN 602 packaging may be obtained from several suppliers, the details of which are available from any Royal Mail Sales Centre. If you use a courier service to ship your samples, please contact the company involved for advice on their own approved packaging.

Parcels should be addressed to: QC Testing Department, Culture Collections, UK Health Security Agency, Porton Down, Salisbury, SP4 0JG, UK

Testing is initiated on Tuesdays and Fridays and takes two weeks for a definitive result. Notification of dispatch of samples to ECACC is very much appreciated.