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PurposeHard gelatin capsules have long been used in a substantial proportion of oral dosage forms. However, they have some shortcomings. Concerns include the potential to become cross-linked, resulting in problems…

Liquid-filled capsules offer significant benefits for active pharmaceutical ingredients (APIs) presenting formulation or manufacturing challenges. Their use is beneficial throughout the different phases of drug development, from preclinical to commercialization.…

As the global biologics market continues to grow, securing speed with scale has never been a greater priority. Here we demonstrate important factors to consider in making optimal outsourcing decisions…

Digital transformation initiatives can often times result in false starts and inefficiencies by overemphasizing “paperless” environments. Such endeavors focus on identifying and converting paper-based forms and procedures to electronic means,…

By Karina Boszko, Head of API Regulatory Affairs and Customer Technical Support Department, Polpharma API Nitrosamines—how has it all started?In July 2018, the pharmaceutical industry was surprised by the unexpected…

The competitive landscape in early drug development is especially prominent in meeting unmet patient needs. In areas where there is a more urgent need to develop orphan drugs, such as…