Guest Columns

  1. Distributed Cell Therapy Manufacturing Trade-Offs You Should Know About 3/5/2025

    For all its patient-centered benefits, producing personalized medicine at the point of care has pitfalls that are worth careful consideration.

  2. 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.

  3. Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials 3/4/2025

    Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.

  4. How To Build Resilience Amid Dynamic Biopharma Vendor Relationships 3/4/2025

    The key to effective vendor management lies in understanding how relationships derail in the first place. Here are some common reasons and tips on how to avoid them.

  5. Why You Should Consider AI-Powered Digital Twins For Smart Manufacturing 3/3/2025

    Digital twins replicate a physical system using real-time data from IoT sensors, industrial control systems, MES, LIMS, etc. AI-driven digital twins add an extra advantage of predictive maintenance.

  6. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

    The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

  7. Pharma 4.0 Adoption Needs Cooperation — Here's How To Build It 2/27/2025

    A recent survey by the International Society for Pharmaceutical Engineering found that an inadequate company culture raised the greatest barrier to digital maturity.

  8. 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.

  9. How To Optimize Downstream Separation With Tagless Proteins 2/26/2025

    The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.

  10. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.