Drug Discovery Featured Articles & Applications

  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. 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.

  3. What Do We (Really) Know About DNA Quality For In Vitro Transcription? 2/19/2025

    Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.

  4. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

  5. How Can 3D Bioprinting Advance Drug Discovery? 2/5/2025

    Biological printing (bioprinting; also called biofabrication) is a form of additive manufacturing that uses living cells, proteins, and nutrients as the basis of raw materials in pharmaceutical development.

  6. 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.

  7. 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.

  8. 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    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.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.

  9. How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS 12/6/2024

    The company’s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.

  10. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

    The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.