Biosimilar Manufacturing solution center

1. 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.

2. How 'Explainable ML' Can Improve Process Performance 1/23/2025

   In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

3. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

   The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

4. 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.

5. Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation 1/16/2025

   API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

6. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

   Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

7. Toward A Gene Therapy Platform: What's The Best Format Of Tangential Flow Filtration (TFF)? 1/13/2025

   Evaluate TFF formats (hollow fiber and flat sheet) and membrane chemistries for AAv gene therapy processing, assessing performance, scalability, economy, and closed processing options.

8. 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.

9. 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.

10. 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.