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Results Culture profiling for phenotypic characterization of CHO cells Since passaging up to 30 passages indicated the emergence of passage-dependent phenotypic drift specifically in growth rate and IgG production, two independent working cell banks (WCB) were derived from a single master cell bank (MCB) at passages 7 and 23

[697] Section 1860D-14B(b)(5)(B)(ii) of the Act further states that for a Part D rebatable drug, the term line extension means, a new formulation of the drug, such as extended release formulation, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation. This language is identical to the definition of line extension in section 1927(c)(2)(C) of the Act

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