Balancing Customization And Standardization With Targeted Medicines

By Elena Meurer

This abstract provides an overview of an article that discusses the challenges faced by companies in handling regulatory differences when manufacturing targeted medicines. It emphasizes the importance of compliance in the pharmaceutical, biotech, and medical device industries and highlights the need for specialized services and solutions to navigate these regulatory differences and ensure optimal patient access to targeted therapies.

The article addresses the challenges of balancing customization and standardization in manufacturing targeted medicines on a global scale. It suggests developing common criteria to address variability in individualized therapies, considering regional approaches to manufacturing and regulatory compliance, engaging regulatory expertise, and collaborating across different disciplines. The article also emphasizes the importance of adapting strategies and processes based on emerging data, regulatory requirements, and market dynamics.