New FDA Guidance for shared Manufacturing of Biologics

Today the manufacturing of biologics requires more and more complex and highly specialized technical equipment and processes. This increased the need for flexible manufacturing agreements between different companies for sharing or contracting development and manufacturing of biologics to optimise costs and risk.

Regarding this development, the FDA published at the end of November the new "Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics". This guidance describes the FDA's current thinking about flexible manufacturing. It will furthermore be useful in early stages of product development, if manufacturing agreements will be probable in the future of development or manufacturing. This guidance supersedes “FDA’s Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics” from 1992. It provides information about "Short supply Arrangements, "Divided Manufacturing Arrangements" as well as "Shared and Contract Manufacturing Agreements".

More about this you can read here.

Compiled by:
Axel Schroeder
On behalf of the European Compliance Academy ( ECA)


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