Industry Insights

61. The Digital Future Of CMC Regulatory Affairs 6/23/2023

    This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.

62. Making it Happen: Project Considerations For Artwork Improvement Programs 3/10/2014

    By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward

    In my first two articles in this series on change and program management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement program and some of the change management aspects to consider in order to ensure the change is delivered in a sustainable way.  In this article, I will look at the design of individual improvement projects to ensure effective delivery.

63. Big Risks Yield Great Rewards In Cell Therapy 2/14/2024

    George White, Cytiva’s GM of Product Management for Cell and Gene Therapy, provides insight into the latest developments and strategies in cell therapy and where this dynamic field is headed.

64. Gloved Vs. Gloveless Filling Machines 7/18/2023

    When selecting an aseptic fill/finish machine, the choice to use a gloved or gloveless isolator will arise. To help with that decision, here are a few attributes to consider.

65. The Art And Science Of Tech Transfer – Transferring Vaccine Production

    Facilities committed to prioritizing COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. 

66. 10 Tips For Western Blot Detection Of Phosphorylation Events 6/7/2019

    The ability to interrogate protein phosphorylation events and aberrant phosphorylation levels is critical to our understanding of various biological and pathological processes, particularly in the research of diseases, like cancer. However, detection of phosphorylated proteins in western blots can be challenging. Following are ten tips to ensure robust data generation and cleaner blots.

67. The Largest LOE Event In US Pharma History

    Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

68. Not All Plate Counting Technologies Are The Same 5/18/2023

    While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.

69. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

70. Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters 6/28/2023

    ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).