Expert Insights On Downstream Bioprocessing

  1. 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.

  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. Go From Batch To Continuous RNA Purification With mAb Equipment And QBD 12/30/2024

    University of Sheffield researchers developed a novel method purify polyadenylated mRNA continuously, which stands to improve productivity and efficiency.

  6. 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.

  7. AP Biosciences' Approach To Complex Antibody Manufacturing 12/19/2024

    The bispecific developer's vice president of antibody discovery, Jhong-Jhe You, digs into the company's approach to purification and analytics.

  8. USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli 12/3/2024

    Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

  9. Research Explores Alternative To EU-Banned Triton X-100 11/20/2024

    One of the best-known viral inactivation agents is now banned in the EU. A group of scientists explored Virodex TXR-1 as a suitable alternative. Here's what they found.

  10. A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS 11/8/2024

    How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?