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.

Bayesian Optimization provides a more efficient alternative to traditional Design of Experiments (DoE) for process development, particularly when navigating multiple factors and levels. This case study highlights an innovative approach involving the exploration of areas characterized by high uncertainty and high potential yield. This focus enabled the identification of optimal operating ranges for critical factors, ultimately maximizing reaction yield.

CEO & Co-founder Mark Barrett reveals how The Medicine Accelerator is transforming medicine development in 2025 with €100M campus expansion, AI-driven iAchieve®, and deep-tech innovation.

This study introduces a hybrid method combining the COSMO-RS model with machine learning to predict aqueous solubility at room temperature.

Explore these innovative approaches undertaken by APC in addressing the challenges of peptide crystallization .

Decentralized manufacturing in pharma, driven by ATMPs, is now extending to traditional large & small molecule medicines, transforming development & production.

Process portability is a concept pioneered by APC which encompasses the capability to seamlessly transfer robust manufacturing processes across different facilities or locations without compromising product quality or efficiency

The recent wave of CDMO acquisitions, COVID-19, and global geopolitical uncertainty has underscored the need for pharmaceutical companies to future-proof their manufacturing operations against potential disruptions. In such a climate, Process Portability emerges as a strategic imperative, offering pharmaceutical companies a proactive approach to safeguarding their operations.

In this webinar, Guangyang Hou, a Senior Process Development Engineer at APC, explores how model-supported approaches in conjunction with the implementation of Process Analytical Technologies (PAT) and continuous processing, can minimize human intervention whilst drastically reducing development times.