Guest Columns & From The Editor

  1. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  2. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

  3. The Building Blocks Of A Robust Analytical Assay 8/1/2025

    Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

  4. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  5. Accelerating NAMs For A Human-Based Future In CGT Development 8/1/2025

    The Complement-ARIE Consortium, led by FNIH’s Stacey Adam, Ph.D., is advancing the development, validation, and regulatory adoption of human-based new approach methodologies (NAMs) to transform preclinical testing and accelerate cell and gene therapy development.

  6. The Rise Of NAMs 7/31/2025

    New Approach Methods (NAMs) are rapidly being accepted as replacements for preclinical animal tests long considered to be the gold standard. NAMs include systems of organoids, organs-on-chips, AI-based prediction models, and non-mammalian species.

  7. Navigating The Complexities Of NK Cell Therapy Development 7/30/2025

    Deloitte's Amit Agarwal and Ashraf Husain share expert insights on how NK cell therapy developers can overcome manufacturing, supply chain, and commercialization challenges to successfully scale these promising therapies.

  8. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

    The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

  9. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

  10. Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs 7/28/2025

    There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.