Guest Columns

  1. How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities 5/20/2025

    A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.

  2. Will Genome Modifications Define Next-Gen AAV Vectors? 5/20/2025

    AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.

  3. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

    The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

  4. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

    Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

     

  5. Using AI To Predict Multispecific Formulation Patterns 5/16/2025

    This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

  6. Good Distribution Practice Is Evolving — Here's How 5/15/2025

    Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

  7. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

  8. ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy 5/12/2025

    Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

  9. A Case For Paying Allogeneic Cell Therapy Product Donors 5/9/2025

    The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

  10. April 2025 — CDMO Opportunities And Threats Report 5/8/2025

    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.