The Process Development Blog

FDA’s 2025 approvals show biologics growing more complex. Learn why next-gen modalities demand stronger analytics, process design, and integrated CMC strategies.

APC & VLE Therapeutics is looking forward to seeing you at Bioprocessing Summit Europe which brings together upstream, downstream, bioproduction, analytical, and formulation professionals to advance the manufacture, quality, and control of biological and genetic therapies.

The Medicine Accelerator is thrilled to exhibit at Advanced Therapies, London 2026! Stop by and say hello!

CRLs often stem from hidden knowledge gaps. Discover how iAchieve® turns tacit expertise into traceable CMC logic to strengthen submissions and reduce risk.

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.