Industry Insights

  1. Critical Success Factors For Cell Line Development 9/3/2020

    Optimal cell line development is crucial for successfully navigating clinical trials and diverse, challenging regulatory approval processes. Discover what you should know about cell line development to ensure a successful launch.

  2. 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.

  3. 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.

  4. A Lean, Agile Business Model To Deliver High-Quality Oncologic Treatments 12/11/2023

    No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.

  5. Smarter CDMO Engagement with AI In Biologics And Cell & Gene Therapy 6/24/2025

    In biologics and cell and gene therapy (CGT), selecting and managing a CDMO has become a strategic imperative. Unfortunately, traditional approaches to external partners can fall short. But now AI is reshaping this landscape. Analysis from an Outsourced Pharma Board member.

  6. Tips For Your Virtual Meetings With The FDA 10/7/2022

    It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

  7. Is Early Automation The Key To Scalable Cell Therapy Manufacturing? 5/8/2025

    Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.

  8. ICH Quality Risk Management Guidelines For Biopharma Manufacturing 11/27/2023

    Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.

  9. Keep An Eye On These Analytical And Monitoring Trends In 2025 12/20/2024

    Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.

  10. Market Watch And Perspectives On Vaccines Manufacturing In APAC 8/16/2023

    Nearly forty biopharmaceutical companies, CDMOs, and research institute executives took part in interviews on the future of vaccine manufacturing. Explore the key findings following these interviews.