Guest Columns
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Emerging Trends In mAbs Manufacturing In 2025 And Beyond
2/11/2025
Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.
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Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars
2/10/2025
With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.
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A Look At Pharmaceutical Inspection Machine Advanced Technologies
2/7/2025
Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.
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Automating Digital Twins Implementation In Downstream Bioprocessing
2/7/2025
One researcher describes a case study in which they simply pressed play on a set of six pre-programmed experiments and returned hours later to a complete data set.
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
2/5/2025
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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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.
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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.
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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?
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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.
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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.