11.14.26 -- Pharmaceutical Online Newsletter - Best Of October

Learn how to best align your development strategy, guide cross-functional decisions, and build a clear pathway from discovery to successful commercialization.

A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. See how this method ensures safety, extends shelf life, and protects from contamination.

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation accelerates commercialization.