Latest Developments and Insights

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…

Authorized by the 21st Century Cures Act , Food and Drug Administration’s (FDA) Oncology Center for Excellence (OCE) was established in January 2017. OCE was established to facilitate the development and clinical review of oncology products by uniting scientific experts…

Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…

What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. The debate surrounding biologics vs…

The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…