Biosimilar Manufacturing solution center

  1. Solvent-Free Purification Of D84-mer Oligonucleotide Using Capto™ PlasmidSelect Resin 1/13/2025

    Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins. They enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.

  2. Single-Step Purification Of A 21-mer Oligonucleotide Using Capto™ Q ImpRes Resin 1/13/2025

    Explore how the oligonucleotide therapeutics market is advancing with scalable solutions for high-purity purification, supporting global production of life-changing RNA therapies.

  3. Bioprocess Operation Modes And Advanced Bioreactor Technologies 1/9/2025

    Explore innovative cell culture methodologies and bioreactor technologies to optimize productivity, enhance product quality, and drive efficiency in biotechnological applications.

  4. 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.

  5. Deploy AI To Become A cGMP 'Special Agent' With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

  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. Keep An Eye On These Analytical And Monitoring Trends In 2025 12/20/2024

    Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.

  9. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

  10. 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.