10.02.26 -- 4 Ways To Building A Better CMC Tech Transfer

A high‑risk facility acquisition in Huntsville became a blueprint for revitalizing a modern campus. Discover how coordinated action turned a massive shutdown into a renewed manufacturing hub.

Sterile drug manufacturing requires preventing and removing contamination. Multi-stage filtration cuts microbial load, protects final filters, and supports quality, efficiency, and patient safety.

Optimizing L-Leucine balances porosity and surface enrichment in spray-dried formulations. Precise adjustments alter particle structure to enhance aerodynamic performance and lung deposition.

A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.

A discussion on what drives CDMO success, from operational discipline and leadership to tackling complex manufacturing challenges and industry trends.

Learn how integrating advanced inspection technology—including X-ray systems, metal detectors, and checkweighers—can optimize your compliance strategy and protect product quality.

Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

Navigating Asian pharma markets requires alignment with local regulations. Standardized documentation, facility registrations, and strong quality systems support compliance and reliable supply.

Poorly soluble APIs can be converted into amorphous solid dispersions to improve bioavailability. A stage-gated approach reduces risk, optimizes polymer selection, and speeds manufacturing.

Medical device manufacturers face growing complexity, needing stronger partnerships, advanced biomaterials, and resilient supply strategies to meet shifting patient, regulatory, and global demands.

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

Proposal delays often start with missing information. Gain insight into what CDMOs need to build accurate timelines, improve planning, and minimize costly scope changes.

When an oral liquid formulation of crizotinib failed pediatric trials due to intolerable taste and irritation, a multiparticulate approach offered a technically demanding but viable path forward.