Upstream Processing

Kuhner TOM For Off-Gas Analysis in Shake Flasks

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To facilitate and speed up process- and media development, online measurement techniques for shake flasks accompany manual sampling for maximum information output per cultivation. Off-gas analysis gives oxygen transfer rate (OTR), carbon dioxide transfer rate (CTR) and respiratory quotient (RQ) as quantitative measures of the physiological state of the culture. On shake flask scale, multiple cultivations are usually run in parallel. Off-gas analysis should therefore be cost effective, easy to handle and versatile to match various applications. Therefore, we developed…

September 28, 2021

Automated Cell Line Development With Greater Than 99% Monoclonality On the Beacon® Platform

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For all cell lines used in production for commercial therapeutics, FDA guidelines require assurance of monoclonality. This standard means that typical cell line development (CLD) campaigns often require multiple rounds of cloning easily spanning several weeks to months. However, Berkeley Lights, Inc. (BLI) has developed the ability to save time and money spent on CLD processes via automation. The uniquely powerful Beacon® optofluidic platform performs single-cell cloning, growth and titer measurements, and recovery of top clones with unrivaled (>99%) monoclonality…

February 5, 2020

Long-Term Reliability of an Aseptic On-line Glucose Monitoring and Control System for Perfusion CHO Cell Culture

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Among the variables that are appropriate for direct feedback control of the perfusion rate in mammalian cell cultures, high priority should be given to the glucose concentration. Here we describe the application of a closed-loop control scheme for the long-term cultivation of CHO cells in a high cell density (35 – 40 million cells/ml) perfusion process. The monitoring and control system worked successfully for 2.5 months without any signs of performance degradation. In targeting industrial applications, issues such as reliability,…

December 15, 2017

Novel Single-Use Systems Allow Faster Powder Transfer and Higher Recovery Rates (Poster)

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Single use powder containment practices are still in their infancy but keeping your product from cross contamination and reducing airborne particulates is important. Understanding how more modern bag designs can increase safety and speed is a concern to the industry. We looked at the ease of fill along with dispensing times and product loss. ILC Dover’s EZ-Biopac shows a 71% decrease in filling times when measured against an industry standard 2D bag. Due to the non-static film we saw an…

December 14, 2017

Immuno-Oncology Therapies: In Vitro Functional Assays for Drug Selection and Development

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The immune system is at the center of a new era in effective strategies to treat cancer leading to significant growth in the immunooncology sector, and the development of competing technologies to further improve patient survival rates. Essential to the successful development of cancer immunotherapeutics are ex vivo and in vitro assays to: Confirm mode of action Compare activity with competitors Identify lead candidates Evaluate and select combinations At Abzena, we have developed a suite of assays to confirm and…

December 14, 2017

Comparison of the Finesse SmartGlass™ and SmartVessel™ 3L Bioreactors: Engineering Data and Cell Cultivation Results

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Finesse Solutions Inc. recently introduced the single-use benchtop scale SmartVessel 3L bioreactor, which was developed based on its re-usable counterpart, the SmartGlass bioreactor. With identical main geometrical parameters, the plastic bioreactor mimics the glass vessel with minor modifications for manufacturability. The following study focuses on the engineering data of both vessels, which have been determined with special focus on animal cell culture applications. Furthermore, data from material tests on leachables and extractables as well as results from cell cultivations using…

December 14, 2017

An Introduction to the FUTURA pico for Mini-bioreactors

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Small bioreactors are gaining share in process development laboratories. It is vital that these bioreactors are realistic scale down models of larger systems and it is equally important that online sensors for measuring live biomass can also be used in these vessels. ABER, known and trusted for its sensors that measure live cell concentrations using capacitance technology and adopted in the world’s leading bio pharmaceutical companies from R&D through to cGMP processes brings you the new FUTURA PICO. Our Conventional…

November 20, 2017

A Systematic Development Approach to Optimize and Control Biopharmaceutical Product Quality

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The complexity of recombinant protein manufacturing processes, including expression systems, cell culture process conditions, and choice of media and feeds, present signifi-cant challenges to achieve desired product quality of bio-pharmaceuticals. To address these challenges, Fujifilm Diosynth Biotechnologies (FDB) has developed a unique systematic approach of combining “Media Toolbox†methodology, key chemical components, and cell culture bioprocess “know-how†to optimize and control manufacturing condi-tions that promote the desired product quality profiles of recombinant proteins. Case studies are presented to highlight the…

December 20, 2016

Targeting Desired N-Linked Glycosylation Profiles Through The Use Of Glycosylation Enhancing Feeds And High Throughput And High Resolution N-Glycan Analysis By Multi Capillary Electrophoresis

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Glycosylation is a key product quality attribute for many biotherapeutic proteins expressed in CHO cells. N-linked glycans may display macro- and micro-heterogeneity; the degree of this variation can depend on several factors, including cell line, media/feeds, and process. As a consequence, it has often been challenging to achieve and maintain preferred glycosylation profiles from cell culture development through bioreactor scale-up. In order to address these challenges, we have developed a new feed technology in conjunction with a unique fed-batch process…

December 20, 2016

High Density Culture Strategies For Improved Scalability With Single-Use Systems

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Improvements in single-use systems have allowed implementing high-density cultures in standard work flows. The current study shows integration of the Thermo Scientificâ„¢ HyPerformaâ„¢ Single-Use Bioreactor (S.U.B.) and the XCellâ„¢ ATF6 Single-Use (SU) System to achieve high-density cultures. Current results are compared against similar cultures using a stainless steel ATF6 system. The S.U.B. was able to support high-density cultures (>40E06 cells/mL) without modification to standard single-use components and maintained proper operating parameters. Scale-up criteria for both S.U.B. and ATF are provided…

December 20, 2016