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Moreover, the directed evolution invention provided herein can provide more wide-ranging possibilities in the types of steps that can be used in mutagenesis and selection processes

However, this method has also a disadvantage such as high production costs of (R)-4-chloro-3-hydroxybutyrate derivate, and a difficulty of application thereof to industrial-scale production in that the reaction must be carried out under high- temperature and high-pressure conditions

and the 503B clinical-need notice, docket FDA-2018-N-3240) and the FDA 503A category list PDF