Articles tagged with “cell-and-gene-therapy”

FDA CGT Guidance 2026: Knowledge Reuse & CMC Submissions

Analyze the June 2026 FDA draft guidance on cell and gene therapies. Understand how reusing platform knowledge streamlines CMC submissions and development.

40 min read

5/16/2026

fda guidance cell and gene therapy cmc submissions platform knowledge genome editing regulatory affairs cgt development

Guide to Montreal Biotech: Companies, Startups & Research

An in-depth analysis of Montreal's biotech ecosystem (updated April 2026). Key companies, startups, research institutions, and the economic drivers of this top life sciences hub — including the latest funding rounds, clinical milestones and the Quebec Life Sciences Strategy 2025–2028.

35 min read

12/24/2025

montreal biotech quebec life sciences biotechnology canada drug discovery biotech startups life sciences hub cell and gene therapy biopharma

San Diego Biotech Companies: A Comprehensive Industry Guide

Explore San Diego's biotech hub, a top 3 U.S. cluster. Updated for 2026 with $4.8B VC funding data, NIH funding crisis impact, major acquisitions (Avidity $12B, Poseida $1.5B), and company updates for Illumina, Neurocrine, Halozyme

60 min read

11/26/2025

san diego biotech life sciences biopharma cluster genomics drug discovery cell and gene therapy biotech industry

Cell & Gene Therapy Logistics: Clinical Trial Supply Chain Guide

Updated 2026 analysis of cell and gene therapy logistics for clinical trials, covering cryogenic cold chain, chain of identity, decentralized manufacturing, and the latest regulatory developments from FDA, EMA, and ICH

40 min read

11/21/2025

cell and gene therapy clinical trial logistics cgt supply chain cryochain chain of identity