Biosimilar Manufacturing solution center

  1. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

    Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

  2. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

  3. Top 10 Data Auditor Statistical Software Requests 1/27/2025

    Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Toward A Gene Therapy Platform: What's The Best Format Of TFF? 1/13/2025

    Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.