Industry Insights

  1. Isolators For Cell Therapy Manufacturing: Considerations & Challenges 4/16/2020

    As cell therapies move toward commercial production through scale up and multiple capacity increases, we as an industry have not come to grips with how to reliably and economically provide the needed capacity within the open manual processes that we have been working with for many years.

  2. Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

  3. A Better Approach To Selecting And Overseeing GCP/GLP Vendors And Processes 10/18/2018

    This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.

  4. India To Enhance Oversight Of Medical Devices 9/25/2019

    India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices, is forming a new division that works exclusively with medical devices. Here’s what we know so far.

  5. Taking GMP Training From Painful To Practical 11/4/2015

    For many, GMP training is an event where attendees are herded into a room and are read the contents of the regulations or asked to watch a video. This video is often the same slides or video year after year.  Then, after this nice little break, everyone goes back to their jobs, forgetting about it until the next time the necessary evil called “GMP training” is required.

  6. Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits 3/19/2020

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

  7. FDA Approval Of The First nr-AxSpA Biologics: Projecting Regulatory & Market Dynamics 2/27/2019

    Although we expect the FDA approval of therapies for non-radiographic axial spondyloarthritis (nr-AxSpA) to be an important event in the coming year, questions remain about the U.S. market potential. Because three therapies are expected to be approved within a similar timeframe, any first-to-market advantage may be limited.

  8. Four Ways MedTech Can Thrive In Emerging Markets 11/26/2018

    Just two percent of the revenues generated by the top 200 medical device companies arise from emerging markets. To achieve greater success, medtech must look beyond the legacy approaches that led to success serving the billion richest patients in the world.

  9. How Will New Trade Agreements Impact The Biopharma Industry? 11/7/2018

    The Trump administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.

  10. Bioburden Sources You Might Have Missed 5/3/2017

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.