Biosimilar Development solution center

1. 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.

2. 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.

3. 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.

4. 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.

5. Should We Refocus On The Product, Then Engineer The Process? 10/14/2025

   Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

6. 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.

7. 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.

8. Take Action On PFAS To Protect Your Critical Processes 9/18/2025

   PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

9. Reliably Predicting Biologics Hotspots From Prior Knowledge 9/5/2025

   Site-specific post translational modifications can seriously affect a molecules stability, function, and structure. These modifications are commonly called "hotspots."

10. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.