Guest Columns

81. New Reference Standards To Support Quality of AAV Raw And Starting Materials 1/31/2025

    The United States Pharmacopeia aims to help gene therapy manufacturers address the challenges that come with complex starting materials like endonuclease and plasmids.

82. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

83. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

    This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

84. Top 10 Data Auditor Statistical Software Requests 1/27/2025

    Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

85. Computer Systems Validation Pitfalls, Part 4: Inattention To Details 1/24/2025

    The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

86. How 'Explainable ML' Can Improve Process Performance 1/23/2025

    In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

87. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

88. Using Simple Spreadsheet DoE To Optimize The Protein Pipeline 1/21/2025

    Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.

89. Suffering High Protein Sieving Losses? It Might Be The Buffer 1/17/2025

    New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.

90. Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation 1/16/2025

    API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.