Presentations

Introduction Process intensification is an approach to improve operational throughput by running a manufacturing process or unit operation differently. In mAb purification, intensified processing can remove bottlenecks created by high bioreactor titers, increase manufacturing flexibility for multi-product facilities, and reduce cost of goods while increasing the focus on product quality. This work focuses on intensifying the anion exchange (AEX) mAb polishing step. AEX polishing is commonly used to provide clearance of host cell protein (HCP) and virus impurities.

 

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Original Publication Date:
09/01/2017

Monoclonal antibodies (mAbs) are important biopharmaceuticals for the treatment of many diseases. During manufacturing, the proteins tend to form aggregates, which reduce product yields, influence drug performance and safety. Environmental conditions during production in mammalian cell culture influence the formation of high molecular weight (HMW) species. In this report, we show how mAb aggregates can be detected directly in the cell culture supernatant using size exclusion chromatography (SEC) in a high pressure liquid chromatography (HPLC) system. We have investigated the impact of batch cultivation in different culture vessels, the addition of Valproic acid (VPA) as small molecule enhancer of protein production and the influence of the cell culture environment itself on the formation of mAb aggregates in Chinese hamster ovary (CHO) cell culture. Our results prove that aggregate formation can occur already during upstream processing (USP) due to intracellular and extracellular mechanisms and is not only a problem in downstream processing (DSP).
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This study evaluates a number of techniques that influence the accuracy and precision of the pipetted volume. The pipette operator has the ability to control all of these parameters by using the appropriate pipetting technique, as well as by choosing the appropriate pipette size and type of pipette tips.


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We have investigated the impact of batch cultivation in different culture vessels, the addition of Valproic acid (VPA) as small molecule enhancer of protein production and the influence of the cell culture environment itself on the formation of mAb aggregates in Chinese hamster ovary (CHO) cell culture. Our results prove that aggregate formation can occur already during upstream processing (USP) due to intracellular and extracellular mechanisms and is not only a problem in downstream processing (DSP).


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The demand for more efficiency and productivity in the laboratory has led to applications using Fast GC-MS methods for routine analysis in a wide range of fields. Many of these applications can involve complex mixtures with some components at trace levels. The fast analysis time requires some unique capabilities, including a GC with fast column heating and cooling for high throughput, a mass spectrometer with high data acquisition speed, and a fast response ion source in order to correctly characterize narrow peaks generated by Fast GC.


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