Small Molecules in FDA’s New Drug Approvals 2025: Implications for 2026 Drug Development
Small molecules still dominate FDA approvals, but rising stereochemical and solid-state complexity demands stronger CMC strategies for 2026 readiness.
Cutting edge process development insights and news from APC.
Small molecules still dominate FDA approvals, but rising stereochemical and solid-state complexity demands stronger CMC strategies for 2026 readiness.
In this presentation, Alexandra Bogdanovic, from APC’s bioprocess development team, delves into some of the key challenges and strategies associated with AAV production optimization.
APC & VLE Therapeutics is looking forward to seeing you at Advancing Drug Development Forum, in Boston which brings together upstream, downstream, bioproduction, analytical, and formulation professionals to advance the manufacture, quality, and control of biological and genetic therapies.
APC’s Powder Drying Optimization approach reframes drying as a controllable design variable, using analytics and modelling to improve speed, yield, and reliability.
October 22 2025: Minister for Further and Higher Education, Research, Innovation and Science, James Lawless TD has today announced a €2million co-funded investment by APC Ltd and Research Ireland. To be funded for the next five years, TRANS-AM is a collaborative research partnership between APC Ltd, the National Institute for Bioprocessing Research and Training (NIBRT), and University College Dublin (UCD), and is focused on advanced biotherapeutics.
Discover how Computational Fluid Dynamics (CFD) helps de-risk scale-up and optimize biopharmaceutical manufacturing. Learn how CFD reveals hidden mixing dynamics, supports tech transfer, improves efficiency, and ensures regulatory-ready process insights.
The Medicine Accelerator joins Manufacturing Day Ireland on 3 October, hosting future innovators to explore careers in science, technology, and advanced manufacturing.
See how CrysAI™ applies deep learning to crystallization and cell imaging—automating segmentation, improving reproducibility, and scaling insight.
APC & VLE Therapeutics is looking forward to seeing you at this CLS event in San Diego which brings together upstream, downstream, bioproduction, analytical, and formulation professionals to advance the manufacture, quality, and control of biological and genetic therapies.