FDA will standardize NDCs to a 12-digit (6-4-2) structure, addressing 5-digit labeler-code constraints while creating a ...

Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...

FDA cleared Tregzi to improve chronic GVHD-free survival, representing a non-pharmacologic strategy to reduce chronic GVHD while supporting immune reconstitution after allogeneic transplantation.

BioPhorum, a global forum for biopharmaceutical industry collaboration, has formed a new working group aimed at accelerating innovation across small molecule manufacturing. 1 The Synthetic Molecule ...

Cohort composition spans sterile small molecules, APIs, commercial cell-culture biologics, rare-disease drug substance, and CGT capacity across NY, NJ, IN, and NC manufacturing hubs. Eligibility ...

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

Eli Lilly was attracted by a deliberately cultivated life sciences strategy anchored in a region where manufacturing represents 16% of gross regional product. Robust talent infrastructure includes 11 ...

Near-instantaneous, quality-reviewed case availability would shift signal detection from periodic retrospection to continuous operations, materially accelerating expedited reporting and downstream ...

Digitally structured, machine-readable standards reduce manual handoffs, rework, and ambiguity by enabling direct integration of quality requirements into LIMS, ELN ...

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report ...

Discover how Piramal Pharma Solutions is innovating in integrated CDMO services, leveraging their Science Collective of experts to streamline drug substance and drug product programs from early ...

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias. The global and historical ...