Biosimilar Manufacturing solution center

1. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

   Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

2. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

   How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

3. Choosing The Best mRNA Manufacturing Strategy 12/12/2025

   Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.

4. How To Reduce Batch Loss In Biopharma Production 12/12/2025

   Batch failures in biopharma remain costly despite improvements. Learn the leading causes in downstream purification and how supplier expertise can help reduce risk and protect production.

5. Lentiviral Vector Upstream Process 12/12/2025

   Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

6. Lipid Nanoparticles Boost CRISPR HDR Gene Insertion in Human T Cells 12/12/2025

   Lipid nanoparticles enable precise, non-viral gene editing in T cells to achieve high HDR efficiency and viability in scalable workflows. Explore how this approach overcomes viral vector limitations.

7. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

   A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

8. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

   Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

9. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

   When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

10. 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.