Material Handling Featured Articles

  1. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

    Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

  2. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

  3. Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead 5/19/2025

    Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.

  4. A Road Map For PAT Monitoring And Control 5/8/2025

    Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

  5. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  6. Recent Developments Identifying Interactive Factors Affecting Tablet Scuffing Seen In The Aqueous Film Coating Process 4/16/2025

    There are three primary root causes of tablet scuffing during the aqueous film coating process, and titanium dioxide plays a role. The author provides recommendations for addressing it.

  7. A Brief History Of Aseptic Processing 3/27/2025

    From Bunsen burners to advanced isolators, aseptic processing has evolved significantly. Delve into the evolution of this crucial manufacturing method, from its early sterilization techniques to today's highly controlled and regulated environments.

  8. Growth And Trends In Topical Drug Contract Manufacturing 2/14/2025

    Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.

  9. Advancements In GLP-1 Analog Formulation: Overcoming Challenges 2/3/2025

    Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment to offer improved patient comfort and adherence while expanding the therapeutic market.

  10. 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?