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FOCUS ON PROCESS ENGINEERING |
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By Life Science Connect Editorial Staff | As the biosimilar industry has expanded, the FDA has gained greater insight into what approaches verify biosimilarity. The agency concluded that comparative analytical assessments (CAAs) can, in certain scenarios, sufficiently demonstrate biosimilarity and, in turn, reduce the need for clinical efficacy studies. | |
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| Total Protein Stain Normalization Protocol | Manual | LICORbio | See how total protein staining offers a robust approach to western blot normalization to minimize variability and improve quantification accuracy, which supports reproducible protein expression. |
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| Seal Replacement As A Cost Avoidance Strategy | Article | Asahi Kasei Bioprocess | Proactive seal replacement in biopharmaceutical manufacturing prevents costly failures and downtime, ensuring product quality and process integrity. |
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| Site Expansion Without Added Compliance Risk | Article | Blue Mountain | Multi-site expansion doesn’t require rebuilding maintenance and calibration programs from scratch. What matters is standardized work, reliable data, and clear oversight that holds up in every facility. |
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| Cost Modeling Analysis Of AAV And LV Manufacturing | Poster | By F. Saltarin, S. Krekels, E. Cameau, and A. Laskowski, Cytiva | Manufacturing scale plays a critical role in viral vector economics. Compare AAV and LV production scenarios to gain insight into how intermediate-scale strategies can reduce cost and risk. |
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PROCESS ENGINEERING SOLUTIONS |
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| Resolving Common Single-Use Concerns | Article | Charter Medical | Demand for single-use production tools, components, and expertise continues to grow as innovative cell therapies evolve. However, concerns and misconceptions abound regarding single-use solutions. |
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