Industry Insights

71. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

72. Improving NDA Approval Odds For New Dosage Forms Of Approved Products 1/31/2023

    Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

73. mRNA Product Purification Process Strategies 2/15/2023

    Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.

74. Supply Chain Transformation, 503B And Reducing Drug Shortages 9/11/2020

    Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.

75. Biopharma Facility Modular Design & Construction: Key Considerations 9/12/2022

    In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.

76. Selecting A CMO Partner For Sterile Injectable Manufacturing 11/10/2021

    Performing the transfer of a product or technology from a small-scale development process to full-scale commercial manufacturing can be difficult, but vetting for the right CMO partner can pose its own challenges.

77. FDA Safety Labeling Requirements 10/17/2013

    Prior to 2007, the U.S. Food and Drug Administration’s labeling authority was limited; the agency could only request changes to the labeling of approved drug products. That changed, however, with the enactment of the Food and Drug Administration Amendments Act of 2007, in particular, section 505(o)(4). In that section, the FDA was given new authority to require safety labeling changes for approved drugs.

    This means the FDA can now order labeling changes if it becomes aware of new safety information that it believes should be included in the labeling of a drug. This article summarizes the FDA’s thinking in this regard, as indicated by its guidance released in recent weeks.

78. 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.

79. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

80. Reduce Risks And Future-Proof Cell Therapies: Advanced Process Analytics 12/6/2022

    Given the complexity of cell therapies, most of the process and analytical development and GMP manufacturing elements should be coordinated with partners that have expertise, equipment, and facilities.