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05.17.21 -- Are You Ready For The FDA's "Data Effect" Tsunami? 8 Steps To Prepare


05.17.21 Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
 
 
State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions. Access the case study to learn more.
Featured Editorial
By Matt Collins, Cignyl, and John Giantsidis, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you ll need to prepare yourself for the influx of questions, audits, observations, warning ....

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01.25.21 -- Research Report Shows Phase II/III Spending Will Increase


01.25.21 Research Report Shows Phase II/III Spending Will Increase
 
Continuing our Cell & Gene Series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
Research firm Industry Standard Research recently published its
Phase II/III Study Trends and Market Outlook report. The goal of this report is to provide readers with a high-level view of the Phase 2 and 3 clinical development space to illustrate current market dynamics and inform strategic planning. ....

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