The Process Development Blog

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.

Avoid FDA Complete Response Letters (CRLs) by focusing on a strong CMC strategy, deep process understanding, and scientific excellence to ensure smoother drug approvals.

The Medicine Accelerator proudly announces its triple win at the 2024 Pharma Industry Awards, securing Biotech Company of the Year, Pharma Company of the Year - SME, and Pharma Industry Company of the Year. Shortlisted in eight categories, APC and VLE stood out for their excellence in scientific innovation, operational performance, sustainability, and talent development.

Decoupling process development from manufacturing gives pharma companies portable, well-understood processes that transfer across facilities and reduce FDA regulatory risk.

We’ve curated a list of key crystallization publications from the past 25 years, showcasing the research and breakthroughs that have defined our approach and expertise. These publications represent the culmination of decades of innovative work by APC’s crystallization experts, illustrating our ongoing impact in this field.

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.

VLE Therapeutics and Biostór's alliance provides end-to-end GMP cell banking from MCB and WCB development to distribution, with real-time shipment tracking.

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

Strong CMC outcomes depend on deep process development. Learn how a science-first approach ensures reproducibility, scalability, and successful tech transfer.