BIO From The Editor and Guest Columns

  1. November 2024 — CDMO Opportunities And Threats Report 12/9/2024

    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.

  2. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

    Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

  3. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

  4. Bayer's Supply Network-Centric Approach To Digitalization 12/5/2024

    Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here's how one company is approaching the monumental task.

  5. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

    The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

  6. Internalizing Nanoparticle Therapeutic Development 12/3/2024

    De facto approaches to treating immune-mediated diseases aren’t very kind to the immune system itself. COUR Pharmaceuticals is leveraging nanoparticles, a purpose-built platform and in-house expression systems to build antigen-specific therapies that treat the root cause of autoimmune diseases.

  7. 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.

  8. USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli 12/3/2024

    Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

  9. Are We Witnessing A New "Age Of The CDMO"? 12/3/2024

    Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

  10. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

    These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.