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By Gautam Shah, Aavis Pharmaceuticals, and Ajay Babu Pazhayattil, Ph.D., cGMPWorld | The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Biophysical Tools For Biotherapeutic Development | Webinar | TA Instruments | Explore essential analytical techniques in biotherapeutics development, as well as explore ITC, DSC, and Rheology—powerful tools for understanding formulation, stability, and efficacy in drug development. |
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| Comparative Analysis Of Batch And Continuous Processes | Case Study | Dec Group | Examine a comparative analysis that showcases the superior performance of continuous processing over traditional batch methods, highlighting key improvements in efficiency and environmental impact. |
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| A Roadmap To Expedited Review Pathways | Article | Quotient Sciences | Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. |
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| Early Solid Form Screening To Guide Drug Development | Article | By Abhijeet S. Sinha, Lonza | Conducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road. |
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| Engineering The Next Wave Of CHO Performance | White Paper | By Wookjae Lee and Migyeom Kim, Samsung Biologics | By combining improved productivity with speed and reliability, companies can optimize their manufacturing strategies, reduce overall costs, and respond more effectively to market demands. |
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| Partnering With Spokane Community College To Build A Program | Q&A | Interview with Tyler Wolf, Jubilant HollisterStier | Gain insight into how SCC launched a biomanufacturing program, building career pathways and community talent for Spokane’s growing life sciences and pharmaceutical manufacturing sector. |
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| Webinar: Alert to Action: How Connected Digital Execution Turns Pharma Data into Decisions | Disconnected data slows pharmaceutical manufacturing, turning alerts into investigations and delaying batch release. This webinar explores how digitally connected execution ecosystems unify execution, documentation, and quality into a digital thread. Learn how contextualized alerts enable informed action, accelerate deviation resolution, reduce errors, and support inspection ready operations while helping manufacturers shift from reactive response to proactive control. Click here to learn more. |
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