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A Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification

Eppendorf

A Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification

27 Feb 2017

Efficient biopharmaceutical process development relies on the Quality-by-Design (QbD) paradigm. QbD is a scientific, risk-based proactive approach to drug development that aims to have a full understanding of how the process and product are related. This knowledge is gained by process analytical technology (PAT). This application note describes the successful integration of external PAT with an Eppendorf DASGIP Parallel Bioreactor System using Eppendorf’s software DASware analyze. The aim was to optimize the performance of a Chinese hamster ovary (CHO) mammalian cell bioprocess.

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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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Cell / Tissue CultureCell culture or tissue culture is used to study the biology of cells or tissues and to isolate cellular products in an environment which can be manipulated and well defined. Accurately control your culture environment with bioreactors or culture incubators, bind your cells to a surface or together with an extracellular matrix. Distinguish cell types with differential media or proliferate cells with certain characteristics using selective media. Enrich your media with supplements such as growth factors, sera and vitamins. Find the best cell and tissue culture products, kits and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell Lines Stem Cells and Primary CellsPrimary cell cultures, established cell lines and stem cells are vital for <i>in vitro</i> and <i>ex vivo</i> experimentation. High-quality cells, optimized for your applications, alongside optimized cell substrates, growth medium and supplements, are critical for experimental success. Explore a range of cells suitable for your applications, including isogenic cell lines, competent cells, induced pluripotent stem cell (iPSC)-derived cell lines, fungal/bacterial/mammalian cell lines, stem cells and cancer cell lines. Find the best cells for your research in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.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.Quality ManagementQuality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. 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.CHODrug DevelopmentDrug development refers to the process of bringing a new drug to market.

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A Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification