Industry Insights

  1. Bioprocessing 4.0: Digital Transformation Of Process Development 11/6/2023

    Discover how, in combination with artificial intelligence, augmented reality, robotics, and digital twins, biopharma 4.0 is changing legacy concepts from the ground up.

  2. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  3. Pursuing Venture Philanthropy With Opus Genetics: The Business Of Biotech 8/10/2022

    Explore new, more agile approaches to overcoming the advanced therapy obstacles inherent to bringing rare disease treatments to market.

  4. Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing 2/4/2025

    Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

  5. 3 Reasons To Invest In Truly Paperless Manufacturing 2/8/2023

    Learn how going paperless on the production floor can produce measurable results that have a significant impact on manufacturing operations, product quality, and the bottom line.

  6. Unlocking The Benefits Of FTZ Subzones For Pharmaceutical Manufacturing

    Explore how a contract manufacturer that is approved as a certified FTZ subzone can help sponsor companies unlock significant benefits and gain a competitive edge in the global pharmaceutical industry.

  7. Why Greater Philadelphia Ranks #2 As CGT Hub 10/10/2022

    Econsult Solutions' "The State of Cell and Gene Therapy in the Greater Philadelphia Region: A Comparative Analysis" analyzed the factors that make Greater Philadelphia a leading CGT hub compared to 14 other U.S. metros in areas including research infrastructure, human capital, innovation output, commercial activity, and value proposition. These assets aggregate to rank Greater Philadelphia as the #2 cell and gene therapy hub, behind only Boston.

  8. 3 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities 6/12/2023

    The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.

  9. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

    The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.

  10. Overcoming The Demand Standoff: How To Help Speed Adoption Of Innovative Medical Technology 5/24/2021

    Despite new breakthrough technologies being cost-effective and easy to use, as well as helping patients avoid surgeries, rehabilitation, and opioid exposure, many patients won’t get the coverage they need to access it due to the peculiarities of the physician–insurer relationship. This article shares lessons learned with sam, ZetrOZ Systems' wearable sustained acoustic medicine technology.