FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
News|Articles|February 13, 2025
Executive Summary: Addressing Regulatory Requirements for CRISPR sgRNA Purity with Orthogonal Chromatography
Author(s)Agilent
The increasing demand for high-purity, regulatory-compliant guide RNA (gRNA) manufacturing in the CRISPR gene editing market underscores the need for advanced production capabilities.
Related to this article
Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.
FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.
Inebilizumab (Uplizna) cut MG-ADL scores by 1.9 points versus placebo, supporting its approval in Japan for myasthenia gravis.
Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.
Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.
As data volumes explode, clinical data harmonization, hybrid cloud, and AI are reshaping biopharma IT into the industry's core growth engine.
Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.