Author Archives: Dan Kopec

Single-Use Technology in Upstream Processing: A Roundtable Discussion

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The Sartorius upstream portfolio addresses key strategic challenges facing the biopharmaceutical industry: Increased speed to clinic/market and lowered capital costs, with improved process control. Fully scalable, proven process solutions for cell line, media, and process development through commercial manufacturing accelerate upstream development and simplify manufacturing. Novel high-throughput development tools for intensified processes incorporate the latest in process analytics, multivariate data analysis (MVDA), and design of experiments (DoE) software tools. These tools are designed to compress development timelines and to scale…

June 4, 2019

eBook: Using Modern In Situ Analytics and PAT for Automated Feedback Control of Critical Process Parameters

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Simply put, the best way to control a critical process parameter (CPP) is to measure that specific parameter, integrate the live signal into your control system, and apply a smart feedback algorithm for an automated control loop. The challenge in doing this for bioprocesses has been due, in part, to the complex, highly dynamic, and variable nature of the process along with the lack of robust, scalable, and multiformat (single-use or multiuse) technologies that can monitor in real time such…

November 29, 2018

Control of Critical Process Parameters Using In-Situ Analytics

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Biopharmaceutical companies can develop entire end-to-end single-use production platforms and use them for commercial manufacture of their biological products. Single-use facilities are flexible, can be implemented quickly, and do not require the large up-front capital investments needed for stainless steel equivalents. However, single-use facilities must be supplied with a large quantity of high-quality consumables. Biomanufacturers should pay close attention to their supply chains for those consumables to ensure that they are robust, integral, and fully compatible with biological expression systems…

December 11, 2017

Integrated PAT Automated Feedback Control of Critical Process Parameters Using Modern In Situ Analytics

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Simply put, the best way to control a critical process parameter (CPP) is to measure that specific parameter, integrate the live signal into your control system, and apply a smart feedback algorithm for an automated control loop. The challenge in doing this for bioprocesses has been due, in part, to the complex, highly dynamic, and variable nature of the process along with the lack of robust, scalable, and multiformat (single-use or multiuse) technologies that can monitor (in real time) such…

November 17, 2017