Posters

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…

Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations

A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. Assessment of the library database used for microbial identifications is a critical component of evaluating a system or service in its ability to generate accurate identifications. Comprehensive depth of entries, accuracy and coverage of relevant species frequently found in aseptic and sterile manufacturing environments have a significant impact on both performance and cost. Databases…

Characterization and Performance of the Mobius® CellReady 200 L Bioreactor System: The next Generation of Single-Use Bioreactors

Successful bioprocessing relies on the ability to accurately and effectively monitor and control critical process parameters. The Mobius® CellReady 200 L single-use bioreactor is uniquely designed with the novel Mobius® Mobius® SensorReady technology, an external loop that enables configurable, flexible and functional monitoring and control. Bioreactor characterization properties such as mixing time, volumetric mass transfer capabilities, temperature mapping and power input define the process design space wherein accurate and effective monitoring and control can occur. Each of the aforementioned characterization…

Efficient Production of Recombinant Antibody Derivatives in Pseudomonas flourescens

P. fluorescens serves as an attractive expression host for the production of stable and biologically active antibody fragments. A proprietary strain of P. fluorescens has been specifi cally developed as a protein production platform to enable rapid identification of strains capable of expressing high titers of soluble, active protein, and refl ects the additional sophistication required of engineered antibody derivatives being developed today. Pfēnex Expression TechnologyTM employs a toolbox of defined P. fluorescens strains containing custom-designed combinations of genetic elements…

Towards the Use of Statistical Modeling to Predict Cell Culture Performance of Hydrolysates

Hydrolysates are complex media supplements composed of many as well as different types of components. Predicting cell culture performance of a particular lot remains an elusive target, other than by small scale cell culture testing which consumes valuable time, effort and resources. In order to reduce the need for incoming acceptance tests by our customers, FrieslandCampina Domo plans to develop a simple analytical assay that accurately predicts cell culture performance. Our Quality by Design project has provided information at the…