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Scale-up of a biosimilar production process with CHO cells from small to bench scale

Eppendorf
27 May 2021

Bioprocess scale-up from small development scale to pilot and production scale is a fundamental part of process development in the biopharmaceutical industry.

In this application note, Eppendorf scaled up a CHO cell culture bioprocess from 1 L using a DASGIP® Parallel Bioreactor System to 5 L using a BioFlo® 320 Bioprocess Control Station.

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Eppendorf BioFlo® 320

Eppendorf

 The BioFlo 320 seamlessly blends beauty and utility in one all-inclusive package. A new industrial design, flexibility between interchangeable autoclavable and single-use vessels, intelligent sensors, Ethernet connectivity, and a new software package are only a few of the features that set it apart from the competition

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Eppendorf DASGIP® Parallel Bioreactor System

Eppendorf

DASGIP Parallel Bioreactor Systems for R&D and process development in both cell culture and microbiology allow for advanced bioprocess control and automation. Parallel processing, precise control of all relevant parameters, user-defined profiles and innumerable automation features result in accelerated and highly efficient process development. Our DASware software solutions support DoE, process historians and comprehensive data management. Configurable solutions address the unique requirements of microbial, phototrophic, mammalian and human cells, stem cell applications, as well as biofuel and biopolymer processes.   Eppendorf DASGIP® Parallel Bioreactor System Features: Advanced process control and parallel operation of up to 16 glass or single-use bioreactors; DASGIP Bioblock for advanced and user-friendly temperature control; Modular design of control units allows for flexible system configurations that meet the demands of specific applications; Control of agitation, pH, level and DO (including customizable cascade modes) in each bioreactor; Variable speed pumps for accurate liquid addition and operation in batch, fed-batch, continuous and cyclic perfusion mode; Optical absorbance measurement for online calculation of e.g. OD600 or cell dry weight; TMFC individual gas mixing of air, N2, O2 and CO2; Online calculation of OTR, CTR and RQ; DASware control Software for advanced process control; Compatible with DASware Software Suite for interconnectivity and bioprocess information management. Applications: Research and development in cell culture and microbiology as well as phototrophic applications; Lab scale fermentation of aerobe and anaerobe bacteria, yeasts and fungi; Cultivation of mammalian, insect and human cell lines; Special applications such as stem cell culture or biofuel/biopolymer development.

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Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.BioprocessingBioprocessing is the use of biological systems for the conversion of raw materials to desired products. This includes the research, development and manufacturing stages of production and can refer to food processing, small-molecule pharmaceutical manufacture, production of recombinant protein therapeutics, or the generation of renewable energy.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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Scale-up of a biosimilar production process with CHO cells from small to bench scale