Industry Insights

1. Creating Aseptic Connections Between Bioreactors And ATF Systems 6/5/2023

   Learn about alternating tangential flow (ATF) and the benefits of large-diameter aseptic connections between bioreactors with a 1 1/2” flow path.

2. Cell Suspension Or Adherent Cell Surface: Which Method Is Right For Your Lab? 6/8/2022

   We review what to consider when selecting an adherent or a suspension platform for your cell culture method to achieve the best growing conditions.

3. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

4. The Need — And Opportunity — To Develop Broad-Spectrum Antivirals 1/3/2023

   One factor contributing to the lack of broad-spectrum antivirals is a lag in testing technology for viruses. This article discusses interferons (a group of signaling proteins secreted by cell types to coordinate the body’s natural antiviral responses) and other potential broad-spectrum antivirals, as well as the new testing initiatives being conducted.

5. 3 Ways To Rethink Regulatory Change In Personalized Medicine 12/14/2021

   The landscape for the regulation of personalized medicine evolves as innovation in personalized medicine increases. Here are a few ways to approach regulations as opportunities, not obstacles.

6. The Chemistry Of Aqueous Cleaning 4/26/2023

   In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

7. Analyzing FDA's Final Q&A Guidance On Transition Biologics 3/12/2020

   For 10 years, the date March 23, 2020 was circled in red on the FDA calendar. On that “transition date,” certain drugs FDA approved under the drug approval statute were “deemed” to have a biologics license instead of a New Drug Application approval. How soon will biosimilars see an impact?

8. The 4 Most Important Elements Of A Successful Sponsor-CDMO Relationship 1/28/2020

   When a sponsor contracts with a manufacturing organization, it takes on oversight beyond that within its own organization. These understated considerations play an important role in a successful relationship.

9. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

   If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

10. 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.