Featured Editorial
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4 Key Steps To Build Supply Chains For Later-Stage Clinical Trials In LMICs
3/6/2025
Gates MRI's head of clinical supply discusses learnings and considerations that he keeps in mind for clinical trial supply chain/logistics.
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The Rise Of AI-Powered Drones In Clinical Logistics And Supply Chains
3/5/2025
Drone technology has significantly advanced, benefiting from improved connectivity, GPS accuracy, and AI/ML.
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Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making
2/27/2025
The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.
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10 Ways To Speed Up CMC In Early-Stage Drug Product Development
2/21/2025
The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.
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ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them
2/19/2025
Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.
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Challenges And Opportunities Of Outsourcing Biopharma Development
2/19/2025
Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
1/30/2025
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
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Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies
1/17/2025
Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.
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5 Benefits Of Using MES For Cell & Gene Therapies
12/20/2024
Cell and gene therapies have unique complexities and challenges. A manufacturing execution system (MES) can expedite your processes and get your product to commercialization faster.
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Key Considerations For Early-Stage CGT Companies When Selecting A CDMO
12/16/2024
For preclinical or early-stage cell or gene therapy companies, proper evaluation of each CDMO candidate should include the raw materials program, QC testing, and more.