Biosimilar Manufacturing solution center

1. High Specific Productivity For Leaner Sustainable Bioprocessing 1/30/2026

   Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

2. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

3. Oligonucleotide Purification And Synthesis 1/27/2026

   Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.

4. Purification And QC Of An RNA 21‑Mer Oligonucleotide Via LC‑MS 1/27/2026

   Learn how buffer choice, gradient strategy, and pretreatment steps influence recovery, purity, and resolution when purifying a native RNA oligo, with analytical confirmation and practical guidance.

5. Scalable, Sustainable Support For Next‑Gen Primer Systems 1/27/2026

   Explore how an optimized solid‑support design enables higher synthesis scales, steadier pressures, and lower solvent use while preserving yield and purity across diverse oligonucleotide lengths.

6. Facility Considerations When Retrofitting Legacy Sites For ADCs 1/26/2026

   Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

7. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

   The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

8. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

   Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

9. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

   Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.

10. Building Enterprise Resilience From QRM Signals 1/16/2026

    Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.