Industry Insights

  1. Biopharma Facility Modular Design & Construction: Key Considerations 9/12/2022

    In facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain standardized modules and components reach, the wider the benefits.

  2. What If We Had Just One Developability Parameter? 10/3/2025

    Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

  3. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

  4. Optimize Scale-Up And Increase Capacity For Vaccine And Therapeutic Manufacturing 11/18/2020

    In order to accelerate development and manufacturing in the era of SARS-CoV-2, companies are designing scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. Read this article to consider a new way of doing business by reviewing existing capabilities, assessing risk tolerance, and identifying key resources to accomplish your goals.

  5. The CAPA Detective 9/16/2015

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

  6. Strategic Partnership Delivers Innovation, Efficiency In Biotech Training 6/9/2020

    While manufacturing training typically takes years, a Cytovance Biologics methodology developed in partnership with academia resulted in a fully-functional biotech floor team in under 3 months.

  7. Connected Data: A Catalyst For Compliance And Smarter Decision-Making 7/21/2025

    Overcome data integrity challenges in your bioanalytical lab. Learn how a connected data strategy streamlines operations and enhances regulatory compliance.

  8. Unlocking Potential: Exploring Treg Cell Therapy

    Treg cell therapy holds immense promise for millions of patients grappling with debilitating diseases. Review strategies for manipulating Treg activity to unleash the full potential of immunotherapy.

  9. 1 Year Out, Where Do We Stand On DSCSA Implementation? 11/21/2022

    This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.

  10. Regulatory Convergence With Aurion Biotech 5/18/2022

    Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.