Industry Insights

  1. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

  2. Testing Water For Pharmaceutical Applications 10/14/2026

    Water classifications hinge on a defined set of analytical and microbiological tests, and matching the grade to a product's intended use determines whether a process overspends or falls short.

  3. Automated Inspection Of Pre-Filled Syringes And Biologics 3/8/2023

    Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Here, we delve deeper into the CCI testing of biologics and effective test methods.

  4. From Setup To Sign-Off: Managing Simultaneous Reviews In Veeva Vault 7/9/2025

    Collaborate on complex documents with ease with an integrative platform that empowers high-volume teams to streamline workflows, boost compliance, and accelerate reviews within a secure environment.

  5. Ensuring Smooth Adaptation Of New Digital Technologies 4/19/2022

    A seamless adaptation of new digital technologies is possible if it is carefully planned and specifically tailored. Explore some of the key points related to the adaptation of digital transformation 4.0.

  6. Facility Design & Construction Tips For Up-Start Biotech Companies 1/4/2021

    Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

  7. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  8. Beyond Visual Inspection: Understanding Acoustical Transparency As A PAT 12/29/2025

    Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive approach enhances consistency, reduces risk, and ensures packaging integrity.

  9. Accelerate The Start Of Your Outsourced Pharmaceutical Project

    In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).

  10. Key Productivity, Scalability Considerations 9/21/2021

    COVID-19 caused biopharma innovators, CDMOs, data management firms, and raw material suppliers to collaborate at a level never seen before. How do we maintain that collaborative spirit under duress?