Search results for " Downstream PD"

Article Driving Change in Biomanufacturing
Whatever the objective, driving change is a challenge. Implementing a new technology into a bioprocess is a big change. The new technology must be fully understood, all regulatory requirements fulfi…

Article Connected Polishing and Concentration Under One Automation Method
Chromatography and tangential flow filtration (TFF) steps are traditionally performed as separate unit operations in downstream bioprocessing. This work aims to demonstrate the capability of the UNICO…

Article ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects. By Feliza…

Poster A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges. • The increased upstream titers in mA…

Article Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations. By Cynthia A. Challener Cell-culture and fermentation are high-…

Article Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…

Poster Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
The use of disposable technologies in downstream processing has increased significantly over the last years, as they reduce the need for time-consuming cleaning and cleaning validation operations as…

Article Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination. The risk …

Article HTPD: Optimizing a mAb Chromatography Polishing Step
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control of man…

Article High-Throughput Process Development Handbook
Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project…

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