Latest Developments and Insights

As drug development advances, the role of Chemistry, Manufacturing, and Controls (CMC) trends in drug development are playing an increasingly critical role. New trends are emerging that streamline processes and meet the growing demand for innovative, sustainable, and personalized therapies.…

Gene and cell therapies are at the forefront of medical breakthroughs, offering new possibilities for treating complex diseases. The success of these therapies heavily relies on the meticulous processes involved in Chemistry, Manufacturing, and Controls (CMC). CMC plays a crucial…

Bringing innovative therapies to market quickly is critical for treating serious medical conditions, and regulatory programs like the FDA’s Fast-Track and Breakthrough Therapy Designations offer a streamlined path to approval. These pathways allow companies to accelerate development and review by…

As gene therapy continues to evolve, it has the potential to transform medical treatment for a range of complex conditions. Alongside these advancements, the role of regulatory affairs has expanded so that these groundbreaking therapies meet the highest standards of…

In the first instalment of our multi-part series, the key differences between biologic drugs and traditional small molecule drugs such as active pharmaceutical ingredient source, molecular size, structural complexity and immunogenicity were introduced.  In this second instalment, we explore the…

In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…