Presentations

This extended abstract book captures some of the presentations and posters from this very exciting conference. We hope that this book will serve as a resource and summary of the first-rate talks and discussions, as well as encourage you to participate in future events in this HTPD conference series.
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Original Publication Date: 2017

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

The use of cellular assays in drug screening continues to grow with over 50% of primary screens using cell-based formats in 2006. The majority of cells used in the drug discovery industry are fresh, using 'just in time' batch processing from in-house facilities. This process could give rise to a number of issues, namely batch variation, scheduling of cell production and capacity management. We describe the use of microcarrier technology in combination with a suitably configured bioreactor to provide a rapid, robust and reproducible approach to cell production. Cells cultured in this way can be removed from beads, cryopreserved in a single HTS batch size format and maintain assay capacity. Learn More

In August of 2008, company representatives from Abbott, Amgen, Eli Lilly, Genentech, GSK, MedImmune and Pfizer were brought together to help advance the principles contained in ICH Q8 (R2), Q9 and Q10, focusing on the principles of Quality by design. Through a series of inter-company and regulatory interactions, the group set out to create a study that would stimulate discussion around how the core principles contained in these guidelines would be applied to product realization programs, with a multitude of real-world scenarios, as opposed to a singular approach. Learn More

Editors Choice from AspenXchange

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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Editors Choice from AspenXchange

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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