Monday, June 25, 2018 Daily Archives

KrosFlo KR2i with KONDUiT: Turnkey Benchtop System for Walkaway TFF Automation

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This webcast features: Philip Yuen, PhD, Application Scientist, Repligen Perform efficient, fully automated downstream tangential flow filtration with volumes from 1mL to 10 Liters. Fully integrated and easy to use out of the box, the Spectrum® KrosFlo® KR2i TFF System from Repligen is the lowest priced fully automated system available today that delivers precise and reproducible control and documentation of TFF processes. The system is compatible with hollow fiber or flat sheet filters, and offers a number of user-defined set-point…

June 25, 2018

US FDA Calls Biologic Makers to ‘INTERACT’ With New Program

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The Agency has launched the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program to help sponsors plan development projects more effectively. The program is being introduced by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to allow potential sponsors to engage with Agency staff and obtain advice on a specific topics or issues critical to early product development. The discussions aim to advance product development by answering sponsors’ questions, removing roadblocks,…

June 25, 2018