Revised recommendations address manufacturing-source submissions, immunogenicity-related testing, impurity thresholds, higher-order structure analyses, and bioactivity assessment, tightening the ...
KPV, and TB-500 to the compounding list, with MOTs-C also recommended, signaling potential near-term changes in legal supply channels. Online “research-use” peptide distribution has expanded without ...
Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for ...
According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system is ...
Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026. This month in pharmaceutical regulations, in the United States, the FDA ...
Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. Pharmaceutical manufacturing is entering a phase ...
Cheryl Barton, a contributing writer for PharmTech Europe, highlights how European biotechs are using AI-driven target discovery to push respiratory treatment beyond broad immunosuppression toward ...
Leading manufacturers now deploy validated agentic AI that detects OOS events, retrieves batch records, correlates prior deviations, and drafts RCA packages, yielding ≥50% faster investigations.
Six months in, pharma manufacturing and development experts reassess their 2026 outlooks and predict what comes next. The "China+1" strategy has evolved into a more aggressive push for multi-region ...
A Cambridge hub leverages dense co-location with universities, hospitals, and ~470 life science companies to compress translational cycles and expand collaboration in data-driven discovery and ...
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