Industry Insights

1. Genomic Medicine Demands Manufacturing Innovation 5/28/2024

   The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.

2. Best Practices: Risk-Based Environmental Monitoring Of Biopharma Facilities 2/3/2021

   While EM programs are one of the most effective tools in monitoring the state of control of classified manufacturing areas, designing an EM program is a relatively complex task. Facilities vary considerably and there is inadequate specific guidance on how to design EM programs and no single standard risk assessment methodology exists.

3. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

   In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

4. Building A High-Fidelity Manual Baseline For Tomorrow's Automated Inspection 7/14/2025

   Future-proof your pharma manufacturing. Discover why manual visual inspection remains foundational and how advanced software can build a high-fidelity baseline for automation success.

5. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

   A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

6. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

   Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

7. Building A Connected Quality And Manufacturing Ecosystem In Life Sciences 12/27/2024

   Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

8. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

   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.

9. ISO 9000:2000: New Standard for Excellence 12/7/2000
   You are probably, by now, more or less familiar with ISO 9000, and you’ve probably heard talk about the new revision known as ISO 9000:2000...
10. The Global Market Landscape For Peptide Drug Conjugates 3/17/2023

    A peptide drug conjugate is a type of drug molecule that combines a peptide with another molecule, such as a small molecule drug or a protein, to create a new compound. New market research shares key factors and trends driving the market, as well as market segment insights.