Guest Columns

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 What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025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

  2. EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety 2/28/2025

    There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

  3. The Landscape Of GLP-1 Receptor Agonists In Diabetes And Obesity Treatment 2/27/2025

    This article shares an overview of market research on GLP-1 drugs, including the anticipated growth of the market and the current leaders in the space.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

  9. 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.

  10. 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.