Industry Insights

91. 4 Factors To Consider When Scaling Up 7/18/2023

    It's essential to understand how scaling up is affecting your aseptic filling operations. Here are four topics to consider to help ensure your drug product will be taken care of and ready for production.

92. Is Your Biologics CDMO Transparent? 12/12/2025

    Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.

93. The Difference Between Regulatory Operations And Regulatory Affairs 8/23/2021

    Just as we need experienced air traffic control specialists to ensure safe airplane travels, life sciences companies need experts who can navigate the inherent complexities of interactions with regulatory authorities who authenticate the safety of products on the market. This blog provides a better understanding of regulatory operations professionals’ objectives and needs  providing insight into the tremendous impact they have on regulated product developers’ successes or failures.

94. EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety 2/28/2025

    There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

95. Continuous Bioprocessing Overtakes Single-Use On List Of Top Technology Trends 10/10/2016

    The desire for innovation in the biopharmaceutical manufacturing industry continues unabated, as companies ramp up their spending on new technologies to improve efficiencies in both upstream and downstream bioprocessing. And while innovation in this industry can be slow to come, the past decade has seen the emergence of several new innovative trends, ranging from the proliferation of single-use devices to growing demand for continuous bioprocessing and modular facilities, according to BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

96. Beware of Underestimating The Value Of A Pre-NDA Meeting 11/19/2020

    This blog covers the benefits and how to prepare for a pre-FDA meeting, what should be in your pre-NDA briefing package, potential topics for discussion as well as who should attend the pre-NDA meeting.

97. What To Expect From A Sterile Injectables CDMO 1/20/2026

    Sterile injectable manufacturing demands built‑in contamination control, rigorous monitoring, skilled personnel, and robust quality systems, far beyond sterility testing, to ensure safety, compliance, and reliable CDMO performance.

98. Data Integrity In Supply Chain Risk Management During Zero Trust 6/21/2021

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

99. Model-Based Control In Continuous Manufacturing of Biotherapeutics 11/10/2021

    During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.

100. Taste-Masking: A Unique Solution To Improve Patient Compliance 8/10/2021

     Taste plays an especially important role in pediatric medications, but it can affect adult compliance as well. No matter age, if you have poor-tasting medicine, you’re more likely not to take every dosage.