Biosimilar Manufacturing solution center

  1. Speed Meets Precision With Process Development Services 11/24/2025

    Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies.

  2. An End-To-End Automated HTP Platform For Cell Line Optimization 11/20/2025

    Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.

  3. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

    The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

  4. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

  5. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

    Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

  6. How One Biotech Company Is Accelerating The Drug Discovery Workflow 11/14/2025

    See how biotech innovation is accelerating drug discovery through AI, miniaturized workflows, and collaborative technologies to reshape how therapies are developed and delivered.

  7. Advanced Therapies Going Mainstream: Are We There Yet? 11/14/2025

    Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.

  8. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

    Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

  9. Understanding Adeno-Associated Virus Vector Impurities 11/13/2025

    AAV vectors hold promise for gene therapy, but removing product-related impurities remains a challenge. Learn how cell line development and process optimization are advancing rAAV production.

  10. Cell Culture Media Demystified For Performance, Quality, And Innovation 11/13/2025

    Cell culture media isn’t one-size-fits-all. Learn how media composition, customization, and analytics can dramatically improve cell growth, productivity, and product quality for complex processes.