The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering. Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective. What should we expect to see from industry and academia to keep the field moving forward?
Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach. Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.
Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria and their interactions with each other can be a key differentiator in the race to get your drug to market.
Fermentation and cell culture can be carried out in batch or continuous processes. Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.
As biotechnology takes a greater role across different industries, a standardized color code system has been created to describe the different roles and applications.
Understand how the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.
When a biologics company is preparing to launch a new product, its manufacturing capacity forecast is subject to a great deal of uncertainty. Biologics developers must consider scale and volume — in that order.
When customers consolidate their supply chain and use one vendor from drug substance through drug product, it can transform the entire drug development process into a more efficient system.
Thermo Scientific HyPerforma Single-Use Fermentor is a unique, robust, and purpose-built solution for microbial fermentation applications, offering flexibility, and efficiency found in single-use systems.
In this study, the native production and titer activity for secreted Proteinase K from Tritirachium album (T. album) during the course of an 11-day culture were compared between the S.U.F. and stainless steel fermentor systems.
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