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The “early health” Vision

New approaches to vaccine production are needed. GE Healthcare Life Sciences contributes to the “early health” vision by supporting advances in vaccine development through innovative manufacturing solutions that help to shorten time-to-market, increase output, and assure quality.

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.…

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…

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…

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.

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…