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( c ) Both the test and index cultures must be traceable cultures , meaning that each has a 44 unique identifier (e.g., lot/batch/subculture, etc., as appropriate) and well-documented 45 propagation history. 46 ( d ) Extensible studies are generally supported by: 47 ( 1 ) sponsors , who establish the experimental objectives; 48

( 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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51 specific responsibilities with respect to the culture verification process. 52

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 53 sufficiently related to that in an index culture to allow the meaningful extension of experimental 54 results from one culture to the other. The relationship between the test and index cultures should 55 be established via propagation history and orthogonal testing. It may also be desirable to use 56 application-oriented testing to ensure study-specific similarities between the cultures. 57 ( f ) Propagation history describes a test culture’s step-by-step derivation from the index 58 culture via a series of propagation events. These data are an essential part of the culture 59 verification process because a culture’s propagation history is impossible to recover through 60 empirical means. Furthermore, production and handling details provide important clues to the 61 health and disposition of the culture that may not be evident through empirical observations, 62 including potential changes in the genetic makeup. 63 ( g ) Orthogonal testing is the use of functionally independent assays to verify the genotypic 64 and phenotypic relatedness of test and index cultures. Orthogonal testing is important for 65

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