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| Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva. |
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FOCUS ON QUALITY/ANALYTICAL METHODS |
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| Accelerating Batch Release With Agentic AI | Article | Aizon | Agentic AI is redefining manufacturing by accelerating batch release and sharpening real‑time insights. With the right data and governance, teams can gain faster analytics and improved efficiency. |
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| Multimeric VHH Nanobody Expression | Case Study | Primrose Bio | Engineering multimeric antibodies via refined secretion leaders and screening improves avidity plus half-life. Such concatemers offer a faster way for making therapeutics with high activity. |
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| Studying Antigen Escape In B-ALL | Video | BD Biosciences | Researchers uncovered a mechanism of antigen escape linked to low Ikaros expression in tumor cells, offering insights into CAR-T treatments. See how multi-omic analysis enabled this discovery. |
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| The Rising Cost Of Product Recalls In Life Sciences | Article | Honeywell Life Sciences | Product recalls are becoming a major concern in life sciences. Uncover why your company must act now to strengthen quality systems and reduce risk across pharmaceuticals, devices, and biologics. |
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| Manual CQV Vs. AI-Powered CQV | Infographic | ValGenesis | Still validating the manual way? With AI-powered CQV, you can reclaim hours lost to protocols and audit prep. What used to take weeks is now done in minutes. |
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| Sensitive Monitoring Of CAR+ T Cells In Peripheral Blood | Poster | By Stefanie Biedermann, Laura Pluisch, Inga Herfort, et al., Miltenyi Biotec | Investigate how CAR-T cells treat hematopoietic malignancies as well as the correlation between flow cytometry and qPCR in monitoring, which validates their combined use for accurate assessment. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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By Bioprocess Online Live | In this opening segment from the Bioprocess Online Live event, “Protecting Bioprocessing Operations and Supply Chains In A Turbulent Economy,” panelists Adam Golin, Jon Lindbloom, and James Sapirstein speak candidly about how U.S. tariffs are affecting the global operating environment. | |
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| FAQs On The Revised EU GMP Annex 1: Volume 8 | Article | West Pharmaceutical Services, Inc. | Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring. |
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| Top Safety Considerations In Biopharmaceutical Manufacturing | Article | By Katie Keller, Asahi Kasei Bioprocess | Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments. |
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