Choose a mycoplasma comparability studies laboratory that will meet agency requirements
Chris Smith, Manager, Mycoplasma Services, Eurofins BPT Lancaster
Mycoplasma contamination in biopharmaceuticals poses significant risks, making testing for mycoplasma a stringent requirement for production. Traditionally, compendial mycoplasma testing has been the only standard that is accepted worldwide to meet this requirement. The testing is sensitive and able to recover live mycoplasma from products but takes a minimum of 28 days to complete. The advent of rapid mycoplasma testing, using molecular techniques such as qPCR, has decreased time to result to days, or even hours with some methods. However, the regulatory agencies have taken an aggressive approach towards the validation of these methods as compared to the compendial methods. Comparability studies between the compendial and rapid methods have been required by the agencies to ensure that the rapid tests are providing results that are non-inferior in sensitivity, specificity, and reliability in relation to the compendial methods.
Comparability studies involve testing duplicate samples of a product matrix that have been inoculated with live organism at low level, one replicate using the compendial method, one replicate using the rapid method of choice. The choice of organisms, inoculum levels, and number of lots to test in the comparability study rely on the product and materials used in production of the sample matrix as well as which agency the regulatory filing will be submitted. Determining these parameters is difficult and takes experience with both the agencies and varying product types to consistently produce results that satisfy the agency requirements. Each study is unique in this way, but all studies must show that the rapid method’s sensitivity, specificity, and robustness as compared to the compendial method meets the requirements determined by the compendia. In the end, comparability studies enable the industry to benefit from faster testing without sacrificing quality. Eurofins possesses the expertise and proven capability to conduct high-quality comparability studies tailored to the specific needs of your products.