Upstream Processing

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

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,…

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

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…

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

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…

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

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…

An Introduction to the FUTURA pico for Mini-bioreactors

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…

A Systematic Development Approach to Optimize and Control Biopharmaceutical Product Quality

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…

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

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…

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

Improvements in single-use systems have allowed implementing high-density cultures in standard work flows. The current study shows integration of the Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.) and the XCell™ 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…

CryoPod™ Carrier: Standardized Portable Cryogenic Handling of Cellular Therapies

Temperature control during sourcing, manufacturing, and delivery of cell therapies is crucial, as fluctuations can affect viability and function of the cells, and potentially, the overall efficacy and safety of the therapeutic product. In many cell therapy workflows, source cells arrive cryopreserved at LN2 temperatures (-150 to -196 °C) and post-manufacturing, cells are again cryopreserved and stored in vapor- or liquid phase LN2 prior to their use in the clinic. In either case, containers filled with dry ice (-50 to…

Efficient Optimization of CHO Cell Culture Medium and Feed for Increased Antibody Production

Traditional medium optimization strategies are labor intensive, costly, and time consuming. In this project, high-throughput screening technology was adopted along with statistical design to reduce costs and decrease time for optimizing culture conditions for maximized antibody production from a custom Chinese hamster ovary (CHO) cell clone. The presented work includes two phases: phase 1 for basal medium optimization and phase 2 for feed optimization. Phase 1 and phase 2 each have two rounds. A DoE screening methodology was used to…