Scale-Up of Enzymatic Processes

This section will discuss selected topics pertaining to scale-up and transfer of enzy-mahc processes for small-molecule API manufacture from laboratory to pilot plant and full commercial scale. 

Many of the issues that should be considered in the sourcing of biocatalysts and biocatalyst-derived materials are much the same as for traditional reagents and chemistry-derived materials. Some of these are cost, quality, reliability of the vendor, control and security of intellectual property (IP), freedom to operate (FTO), the vendor s business model, avoidance of being single sourced, etc. Some of the perceived differences and issues are often due to the fact that biocatalysts, and somc-ing aspects associated with them, are still an emerging or developing area. 

Need for Multiple Vendors/CMOs to Execute a Complete Process 

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