Industry Insights

  1. Opportunities And Risks As Biosimilars Come Of Age 6/12/2024

    As biosimilars mature, they promise expanded patient access and healthcare savings. Despite regulatory hurdles, collaboration and innovation will drive their future growth and impact.

  2. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

  3. Optimizing Clinical Bridging Strategies For Combination Drug Products: A Risk-Based Approach 5/21/2025

    Clinical bridging studies demonstrate bioequivalence or bioavailability for drug-device combinations, using pharmacokinetic parameters and a risk-based, four-step approach to support regulatory approval and product transitions.

  4. Why All Biotech Companies Need A Strong Commercial Mindset from The Earliest Stages 10/28/2021

    Does commercialization strategy matter when you are years from having a commercial product?

  5. 3 Do's And Don'ts For Implementing A Productive Digital Environment 3/6/2023

    As manufacturers continue prioritizing digital transformation, here are some key factors to keep in mind and consider for the future.

  6. Do You Have an FDA Audit Process in Place? 2/23/2023

    Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.

  7. Patient Empowerment Through The European Health Data Space (EHDS) 8/12/2025

    A new regulation in the EU will give patients more control over their health data. Discover the opportunities and challenges this shift presents for the future of patient-centric healthcare.

  8. The Best ex vivo Storage Option For Biopreservation Of Transplant Grafts

    There are almost as many opinions on the best ex vivo storage media for follicle grafts during a hair transplant procedure as there are hair transplant surgeons.

  9. Keep Pace With Pharma Manufacturing Trends With Modernized Technologies 6/6/2022

    Learn how to gain a lead position in the market by digitally connecting and unifying all areas of your enterprise.

  10. CDMO Innovation For The Future Pharmaceutical Supply Chain

    We have a longstanding mantra, “challenges frame opportunities.” This applies to how we intentionally innovate, modernize, and introduce new capabilities and expand capacity.