ABSTRACT
The document is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce r-DNA derived proteins. Segments of the expression construct should be analyzed using nucleic acid techniques in conjunction with other tests performed on the purified recombinant protein for assuring the quality and consistency of the final product. The purpose of analyzing the expression construct is to establish that the correct coding sequence of the product has been incorporated into the host cell and is maintained during culture to the end of production. The protein coding sequence for the recombinant protein product of the expression construct should be verified. The limit for in vitro cell age for production should be based on data derived from production cells expanded under pilot plant-scale or full-scale conditions to the proposed in vitro cell age or beyond.
