Featured Pharma Online Editorial

  1. 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.

  2. Areas For Advancement In Peptide Manufacturing 2/27/2025

    Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.

  3. 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.

  4. For Gilead, Sustainability Is More Than A PR Effort 2/14/2025

    Gilead's chief sustainability officer and SVP of operations, Joydeep Ganguly, explains the company's cultural focus on sustainability and how it influences everything from R&D to manufacturing. 

  5. Are Plant-Based APIs The Future Of Pharma And Nutraceuticals? 1/29/2025

    As consumer preferences for natural and organic products rise, pharma and nutraceutical companies are increasingly shifting to plant-based APIs. This article shares new market research, including a spotlight on cannabis-based APIs.

  6. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

    The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

  7. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

  8. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  9. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

  10. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.