Newsletter | October 9, 2020

10.09.20 -- Bioprocess Intensification Resources And Best Practices

Developing A Continuous Large-Scale Perfusion Cell Culture Process

Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing spent media and waste products, as compared to batch and fed-batch processes. The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality. 

Developing A Closed Connected Single-Use mAb Purification Process

Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAbs). The key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

Using In-Line Sensors For Real-Time Control

Within biopharmaceutical production there is a shift from manually monitoring processes to real-time control and automated intervention. The goal is to develop algorithms and AI solutions that are able predict outcomes and create autonomous systems. This article exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.

A Scale-Down Model For A Production-Scale mAb Perfusion Process

As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quickly follows. Perfusion continues to be one such operating mode that lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach. 

Strategies For Intensifying Your Biomanufacturing Processes

An increase in therapies targeting smaller niche segments of the market, rather than blockbuster drugs for large patient populations, is creating new pressures on biomanufacturers to meet patient needs. This ebook contains solutions and strategies to consider for faster and more flexible, cost-effective approaches to drug development and manufacturing.