Biosimilar Development solution center

  1. How To Double Up With A CDMO To Reduce Risk 12/12/2025

    Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

  2. Biologics CDMO: 3 Qualities Often Overlooked 12/12/2025

    A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

  3. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

    Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

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 FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025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

  5. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  6. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

  7. Collaboration An Untapped Fuel For Driving Biopharma R&D 10/20/2025

    Biopharma’s future depends on collaboration. Discover how cross-industry partnerships and shared resources can accelerate innovation, overcome talent gaps, and strengthen the global R&D ecosystem.

  8. Why Biopharma Breakthroughs Aren't Moving The Market 10/20/2025

    Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

  9. Optimization And Scale-Up Of A Plasmid DNA Production Process 9/30/2025

    Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

  10. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

    Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.