Antibody fragments have the potential to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). The introduction of Captoâ„¢ 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…
Downstream Processing
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…
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…
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…
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…
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-Simplexâ„¢ 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.…
Toward Nonantibody Platforms
Monoclonal antibodies (MAbs) remain the largest segment of the biopharmaceutical market, but they are not the only recombinant proteins in development. Remember that the first biopharmaceutical approved for sale was recombinant insulin — a hormone — back in the 1980s. And proteins aren’t the only recombinant biologics. The sector has expanded since then to include gene therapies and viral vectors, vaccines, and even cells and tissues. Companies around the world are developing such products for cancer, neurological, infectious disease, metabolic,…