Expert Insights On Cell Line Development

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery 11/5/2024

    Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.

  8. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

  9. Harnessing Analytics To Minimize Antibody Variants And Speed Up Development 7/30/2024

    Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization.

  10. Balanced Sourcing Of Custom Media/Buffer Formulations, Part 2: The Case For Insourcing 6/6/2024

    In part 1 of this 2-part series, the authors discussed the case for outsourcing of custom media/buffer formulations. In this article, they discuss key considerations in the case for vertical integration, or insourcing.