Featured Outsourcing Editorial

  1. Using Virtual Reality To Enhance Aseptic Contamination Control 5/1/2025

    Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

  2. AI Vs. Humans In Novel Drug Target Identification 4/30/2025

    Artificial intelligence is beginning to replace humans in drug discovery, one expert warns — but the industry isn’t ready for the shift.

  3. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  4. A Checklist For Mechanism-Based Potency Testing In Cell Therapy 4/25/2025

    New research concludes that potency cannot be decoupled from a product's mechanism of action because surrogate markers fail to capture functional relevance.

  5. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  6. The Strategic Role Of Cost Modeling In Pharmaceutical Procurement 4/24/2025

    Selecting a CDMO depends on price, geography, expertise, and other variables. While price is often a key motivation for the decision, it is production cost that should be carefully considered. An independent analysis can be of great help. An Outsourced Pharma Board member presents some scenarios.

  7. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  8. Common Manufacturing Challenges For LBP Formulations 4/23/2025

    As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

  9. What CDMOs Wish Biotechs Knew Before Submitting An RFP 4/23/2025

    This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.

  10. 8 Actions To Redefine Sponsor–CDMO Relationships 4/22/2025

    When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.