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 optimisation reduces pharmaceutical reaction development from 1,200 to a manageable experiment subset, identifying optimal yield conditions faster using Gaussian Process Regression.

APC's 2025 Tech CMC strategy turns CMC data into AI-readable medicine histories, with iAchieve logging 1M+ interactions and 40% time-to-manufacture cuts.

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

Explore peptide crystallization techniques including solvent screening, co-crystallization, and in-silico modelling to overcome scale-up challenges in peptide manufacturing.

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

APC experts explain process portability: how science and digitalisation help pharmaceutical companies reliably transfer manufacturing processes across global sites.