Posters

Purification of Antibody Fragments: A New Route for Capture

Antibody fragments have the potential to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). The introduction of Capto™ L, with its protein L ligand, provides a possibility for an industrial platform purification approach for capture of this class of biomolecules. Capto L can bind a broad range of antibody fragments containing kappa light chains. Capto L is the latest member of chromatographic media (resins) in the toolbox consisting of several different products with affinity for the…

Novel Plastic Bag for Monoclonal Antibody Final Bulk Storage to Actively Prevent Oxidation

Essentially, human protein such as monoclonal antibody is quite susceptible against oxidation. Nevertheless using the oxygen barrier containers, oxygen within the protein solution and oxygen leaking through the closure port of container affect to the protein. To minimize oxidation of monoclonal antibody, novel plastic bag for monoclonal antibody final bulk storage has been developed. The concept “Active” means that removing oxygen not only passively from the circumstances through the barrier layer within the container (or bag), but also actively removing…

AbSolute® High Cap by Novasep: Revolutionary Protein A Media

Novasep has developed AbSolute® High Cap, an optimized silica-based protein A media for the capture of monoclonal and polyclonal antibodies. This protein A media is adapted to all fermentation volumes while offering the highest dynamic and static binding capacities (DBC10% ≥ 60 mg/mL, SBC ≥ 95 mg/mL) and, as a result, high productivities at all velocities. By decreasing the amount of resin required to downstream a feed (30-50% less), AbSolute® High Cap enhances the robustness of the protein A capture…

Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs

Traditionally, a bioprocess is characterized using a two-step approach involving factor screening designs followed by response surface designs. This approach is very costly and time consuming since it requires a significant number of runs. Recently, Jones and Nachtscheim (2011) described a more efficient design that allows for factor screening, resolution of two-way interactions as well as estimation of quadratic effects in a single-step. The design, termed Definitive Screening has not yet been validated on a bioprocess. Here, traditional and Definitive…

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…

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…