Single‐Use Technologies for Biopharmaceutical Production: Report from the Working Group Bioprocess Technology – Upstream Processing

Abstract

The main goal of the Bioprocess Technology working group is to overcome existing knowledge deficits in the bioprocess characterization of single‐use bioreactors. The required methods have been investigated extensively, evaluated for their suitability for certain single‐use bioreactors, and summarized into a basic structure in the so‐called conceptual matrix. Development of standard operating procedures for the methods selected as well as their verification in interlaboratory tests guarantee that in the future a spectrum of unified and validated methods can be used to compare different bioreactor types objectively.

Bioreactor Technology for Sustainable Production of Plant Cell-Derived Products

“…Mixing ensures a sufficient supply of nutrients and prevents the accumulation of toxic metabolites during fluid homogenisation and particle suspension. In order to determine the quality of mixing, the mixing time is often used [90,91]. For small scale bioreactors, it is generally easy to ensure good mixing and thus low mixing times.…”

Harmonization and characterization of different single‐use bioreactors adopting a new sparger design

“…in tank and stirrer geometry, position of probes, gas distribution systems), a one-to-one comparison of different bioreactors is often hindered [5]. Furthermore, the characterization of single-use bioreactors is not harmonized aside from the technical aspects, due to differences in the study design and the applied methods [6]. When different systems are adopted for the same cell culture processes, e.g.…”

“…in tank and stirrer geometry, position of probes, gas distribution systems), a one-to-one comparison of different Correspondence: Dr. Benjamin Minow (benjamin.minow@ rentschler.de), Rentschler Biotechnologie GmbH, Erwin Rentschler Straße 21, D-88471 Laupheim, Germany Abbreviations: API, active pharmaceutical ingredient; DHS, drilled hole sparger; S.U.B., Thermo Scientific Hyclone Single-Use Bioreactor; XDR TM , Xcellerex Single-Use bioreactor bioreactors is often hindered [5]. Furthermore, the characterization of single-use bioreactors is not harmonized aside from the technical aspects, due to differences in the study design and the applied methods [6]. When different systems are adopted for the same cell culture processes, e.g.…”