Biosimilar Manufacturing solution center

1. The Scale-Up Of A Transient rAAV8 Production Process 6/18/2026

   New approaches to suspension cell culture and process scaling enable consistent, high-titer rAAV production. Gain insight into a clearer path to scalable manufacturing for gene therapy pipelines.

2. Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs) 6/15/2026

   ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.

3. ADC Manufacturing: Practices, Challenges, And The Road Ahead 6/15/2026

   ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.