The Process Development Blog

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.

This on-demand webinar from The Medicine Accelerator examines how ATMP developers can move from lab-scale development toward GMP manufacturing with stronger process understanding, quality control, and technology transfer planning. The session focuses on an oncolytic virus case study that achieved a 400% increase in viral yield and a 90% reduction in cost per dose. Topics include ATMP process development, upstream and downstream optimization, impurity profile improvement, manufacturability, GMP readiness, regulatory considerations, tech transfer, clinical manufacturing capacity, and faster time to patient.

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.