SPADA Meeting Book

( 1 ) sponsors , who establish the experimental objectives;

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( 2 ) culture producers, who manufacture and characterize the study’s traceable cultures; and

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( 3 ) performers, who conduct the study.

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49 specific responsibilities with respect to the culture verification process. 50

These roles can be filled by the same or different organizations. However, each role has

( e ) Culture verification is the process by which the species in a test culture is shown to be 51 sufficiently related to that in an index culture to allow the meaningful extension of experimental 52 results from one culture to the other. The relationship between the test and index cultures should 53 be established via propagation history and orthogonal testing. It may also be desirable to use 54 application-oriented testing to ensure study-specific similarities between the cultures. 55 ( f ) Propagation history describes a test culture’s step-by-step derivation from the index 56 culture via a series of propagation events. These data are an essential part of the culture 57 verification process because a culture’s propagation history is impossible to recover through 58 empirical means. Furthermore, production and handling details provide important clues to the 59 health and disposition of the culture that may not be evident through empirical observations, 60 including potential changes in the genetic makeup. 61 ( g ) Orthogonal testing is the use of functionally independent assays to verify the genotypic 62 and phenotypic relatedness of test and index cultures. Orthogonal testing is important for 63 identifying genetic or physical changes that might have resulted from laboratory handling and 64 could impact the validity of an extensible study. 65 ( h ) Application-oriented testing is designed to assess the relationship between the test and 66 index cultures with respect to the specific genotypic or phenotypic phenomena being evaluated 67

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