A recent FDA Guidance document titled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations" outlines recommendations on the design and evaluation of comparative analytical studies intended to support a therapeutic protein product. This includes conducting an appropriate physicochemical and functional comparison of the stability profile of the proposed product, accelerated and [...]The post Why the R&D Group Need Not Fear the Package and Distribution Lab When Developing an Injectable Biologic Product appeared first on DDL.
