Biosimilar Development solution center

1. 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.

2. 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.

3. 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.

4. 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.

5. 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."

6. 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.

7. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

   Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

8. The Building Blocks Of A Robust Analytical Assay 8/1/2025

   Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

9. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

   Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

10. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.