Featured Editorial

  1. 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.

  2. 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.

  3. 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.

  4. How Lumen Is Putting The "Farm" In Biopharma 7/31/2025

    Lumen Bioscience's SVP of production and development, Craig Behnke, Ph.D., explains how the company is cutting costs and rethinking upstream manufacturing with its algae-based production platform.

  5. 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.

  6. 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.

  7. The Safety Potential Of Conditionally Active Biologics 7/28/2025

    Conditionally active biologics (CABs) are an emerging class of therapies that can reduce off-target toxicity in the clinic, and they were a topic of conversation at the 2025 BIO International Convention.

  8. CDMOs Should Stop Stringing Biotechs Along 7/28/2025

    Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.

  9. 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.

  10. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.