Expert Insights On Upstream Bioprocessing

  1. 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.

  2. 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.

  3. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

    The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.

  4. Hear Me Out — Cell Therapy GMP Starts With The Donor 1/9/2025

    Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.

  5. A Justification For Using In-Process Controls In Place Of Cleaning Validation 1/9/2025

    This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

  6. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

  7. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  8. How Do We Best Meet Future AAV Production Challenges? 12/20/2024

    In the recent past, viral vector manufacturers feared a capacity crunch. Now, with vastly improved productivity, predicting demand is a challenge.

  9. Cell Culture Trends To Watch In 2025 12/12/2024

    Three upstream processing experts weigh in on advancements from the past year and what they're looking forward to in the year ahead.

  10. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.