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.

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.

This on-demand webinar from APC explores how Crystallization-Induced Diastereomeric Transformation, or CIDT, can improve diastereomeric salt crystallization for chiral resolution. The session covers solubility behavior, phase relationships, counterion selection, solvent choice, solid-state control, and analytical strategies for improving enantiomer separation. It is relevant for pharmaceutical development teams working on chiral molecules, double salts, crystallization process design, yield improvement, purity optimization, scale-up, and enantiopure compound production.

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