Posters

T Cells Expanded in the WAVE Bioreactor™ 2/10 System Maintain a Healthy Phenotype

T cell immunotherapy often requires the expansion of a small select starting population in vitro. To achieve therapeutic doses, this population is required to undergo multiple and rapid rounds of replication. Rapid T cell expansion raises the possibility of inducing senescence or an aged phenotype, both of which are detrimental to the recipient patient. The WAVE BioreactorTM System is often used for the final expansion phase before patient infusion and we have analysed the aging characteristics of T cells that…

Transfer of Hepatic Progenitor Stem Cell Culture Process from Multitray Stacks to the Integrity® Xpansion™ Multiplate Bioreactor

Scale-up a stem cell process may be challenging: small variations in physicochemical parameters (surface characteristics, pH and dissolved oxygen) can heavily impact stem cell growth and behavior. The Integrity® Xpansion™ multiplate bioreactors have been designed to enable an easy transfer from multiple-tray stacks process by offering the same cell growth environment: stacked hydrophylized polystyrene plates in a compact and closed system (from 10 to 200 plates per bioreactor equivalent respectively to 6120cm² and 122400cm²). As there is no headspace between…

EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

Endotoxin or lipopolysaccharides (LPS) are highly toxic components of the cell wall of Gram-negative bacteria and are often present in significant amounts in bacterial cell culture expression systems such as E. coli. A number of methods have been adopted for the removal of endotoxin based on adsorption, in particular ion-exchange chromatography. Although downstream processing can significantly reduce endotoxin levels in the product, efficient and cost-effective removal of residual endotoxin from biopharmaceutical preparations remains a challenge. This technical poster addresses the…

Bio-Simplex™ Single-Use, Aseptic PreCulture Systems

The growth and aseptic transfer of a microbial pre-culture from seed vial to bioreactor is a critical process step in the production of BioPharmaceuticals. The pre-culture step is performed in a biological safety cabinet or laminar flow hood, which adds time and significant cost and to the process. Saint-Gobain Bio-Simplex™ Single-Use Pre-culture Systems provide a sterile environment for cell culture and aseptic transfer of all fluids in and out of each cell culture vessel.

Sartopore (R) Platinum Sterile Filtration, Redefined

We introduce a new class of Sterile Filtration for Biopharmaceutical industry with Sartopore® Platinum. It offers exceptional total throughput, thanks to its patent-pending TwinPleat technology with 1 m2 area/10” element. At the heart of Sartopore® Platinum are PES membranes permanently hydrophilized with proprietary grafting of thermally stable polymer on to membrane surfaces. This leads to minimal wetting requirements prior to Integrity testing with < 5 L./10” preflush needed in < 1 min. They also offer low Protein Binding and low…

A New Mixed-Mode Resin for Large Scale Biomolecule Purification

Chromatographic resins with high capacities and selectivities differing from those seen with traditional hydrophobic interaction and ion exchange media are now in demand. Mixed-mode chromatography media is an alternative. Some mixed-mode resins combine both traditional hydrophobic interaction and ion exchange media. This poster introduces TOYOPEARL® MX-Trp-650M, a high-capacity weak cation mixed-mode resin for the purification of biomolecules. The polymethacrylic base bead was chemically modified with the amino acid tryptophan which combines a weak cationic group with a hydrophobic functional group.…

Evaluation of a Novel Polymer Based Protein A Resin for the Capture of Immunoglobulins and Fc-Fusion Proteins

In the biopharmaceutical industry ever increasing monoclonal antibody titers in cell culture have necessitated discovery of more efficient Protein A capture operations, realized in terms of higher binding capacity, faster throughput, increased resin lifetime, and decreased cost of goods. Recent changes in the Protein A intellectual property landscape have invited new competitors to enter this market. Given the increased availability of new Protein A technology, Biogen Idec has evaluated a prototype resin being developed by JSR Life Sciences known as…

Comparison of Commercial Kits for Extraction of Residual Host Cell DNA

Expression of therapeutic proteins in cultured cells is a cost effective method for production of commercial quantities of a drug substance. However, the manufacturing and purification process of these products leaves the potential for DNA contamination from the host cells. Due to the theoretical potential for the transfer of oncogenes from the host cell, the WHO has set a residual host cell DNA limit of 10ng/dose in biologic therapeutics. Regulatory agencies have set allowable limits between 100pg/dose and 10ng/dose depending…

New Core Bead Chromatography Medium Enables Group Separation and High Productivity Purification of Large Molecules

When large biomolecules such as IgM or influenza virus are purified, group separation with gel filtration is the most commonly used technique. Advantages of using gel filtration include the high purity and the high recoveries that can be achieved, while a drawback is the relatively low productivity. Capto™ Core 700 is a chromatography medium (resin) from GE Healthcare Life Sciences designed with core bead technology. The core bead technology enables double functionality for Capto Core 700 – size exclusion and…

Improving Cell Culture Productivity with a SEGFLOW® Automated On-line Sampling and Feed System

A SEGFLOW® automated on-line sampling and feed system (SEGFLOW) was evaluated for its impact on Chinese Hamster Ovary (CHO) cell culture process performance in bench-scale stirred tank bioreactors. The SEGFLOW was integrated with a YSI® Biochemistry Analyzer and a nutrient feed pump allowing real-time glucose analysis and automated glucose feeding to be performed for the test batch. In contrast, a batch using daily manual sampling and bolus feed protocols, was performed as a control. For the SEGFLOW culture, media glucose…