Biosimilar Manufacturing solution center

1. Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors 6/15/2026

   Progress in gene therapy manufacturing is being driven by improved cell line performance and scalable bioprocessing. See how high-density growth helps streamline development to larger-scale production.

2. Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline? 6/10/2026

   Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

3. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

   This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

4. Affinity Membranes Are Moving Closer To Commercial Reality 6/5/2026

   A recent review shows advances in surface chemistry and ligand engineering are moving the needle for next-generation affinity membranes.

5. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

   AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

6. The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process 6/2/2026

   Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

7. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

   Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

8. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

   In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

9. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

   This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

10. Evaluating Antibody Fragment Purification Using VH3 Resin 5/22/2026

    Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.