Guest Columns

11. Calculating The Process Capabilities Of Cleaning Processes: A Primer 11/1/2021

    The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes. 

12. Where Is Technological Innovation Needed For CAR-T Manufacturing? 10/29/2021

    Investment in cell therapy biomanufacturing has continued to follow a steady upward trend. Even with the anticipated increases in capacity, there are still concerns facing current and future cell therapy manufacturing capacities, including an anticipated “capacity crunch.” This article examines where technological innovation is needed to avoid this capacity crunch.

13. 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?

14. Benefit Design In Medicare Exacerbates Vaccine Access Inequity 10/27/2021

    Vaccines are widely regarded as the most cost-beneficial intervention in healthcare. Unfortunately, and counterintuitively, current cost-sharing policies discourage our most vulnerable population – seniors – from accessing vaccines.

15. The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials 10/25/2021

    While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques. 

16. Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications 10/22/2021

    While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.

17. Updated Orange Book/Biologic Patent Study: Key Learnings 10/20/2021

    Recently in 2021, the United States Patent and Trademark Office published an update to its 2019 Orange Book patent/biologic patent study report, analyzing America Invents Act post-grant proceeding outcomes for biologic patents and Orange Book‑listed patents between Sept. 16, 2012, and June 30, 2021. This article shares key learnings.

18. 25 Years Of VST Therapies: The Journey Behind The Technology And Innovation 10/19/2021

    This article explains the major stepping stones to preventing and treating serious viral infections in high-risk populations with T cell deficiencies.

19. Computerized Systems Validation And Audit Trail Requirements 10/18/2021

    A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption  challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.

20. The Essential Components Of A Sterility Assurance Program 10/15/2021

    The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.