Industry Insights

31. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

32. Congressional Bill Supports Advanced And Continuous Manufacturing 1/5/2022

    The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

33. Mass Spectrometry From Discovery To Launch 1/21/2026

    Mass spectrometry is now a fast, sensitive tool that supports drug discovery, development, quality control, and lifecycle management through detailed molecular analysis.

34. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

    Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

35. Deploying A Vendor Life Cycle Oversight Model 1/9/2026

    A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.

36. Solving The 4 Serialization Challenges Of Track & Trace 11/17/2021

    More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.

37. Genomics: The 2 Biggest Trends & An Unbiased Look At Vendors 8/28/2023

    Biotechs are increasingly looking into genomics as a way to accelerate drug discovery and development, and are increasingly looking to vendors for support in this. Let's look at new market research sharing the two biggest trends and an unbiased look at the prominent vendors.

38. Do Patient Needs Define Biologic Product Specifications? 3/14/2025

    Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

39. The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy 11/8/2024

    Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.

40. Here's Why Outsourcing To CDMOs Doubled In 13 Years 10/4/2023

    It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.