mAb Development

Oct 09, 2007
BioPharm International
By BioPharm International Editors
Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1.
Oct 01, 2007
BioPharm International
By BioPharm International Editors
In one series of experiments, the glycosylation site of IgG1 was removed and an IgA glycosylation site was introduced—resulting in a total loss of biological function.
Oct 01, 2007
BioPharm International
Regulatory agencies have evolved along with the biotechnology industry to define quality standards.
May 01, 2007
BioPharm International
This flexible setup minimizes the number of purification process steps, buffers, and process components.
Mar 01, 2007
BioPharm International
To shorten time to market for new therapeutic proteins, new and fast methods, such as high throughput screening, are needed to speed up downstream processing. The platform technology discussed in this article includes a structural approach that can be used as a general procedure to purify therapeutic proteins. The approach starts with ligand screening and selection-on-a-chip, with the Surface Enhanced Laser Desorption Ionization–Time of Flight (SELDI–TOF) mass spectrometer system. Next, resin screening and supplier selection are performed using robotics, followed by scouting studies under dynamic conditions to select the best resin. Finally, optimization studies of critical parameters are carried out with statistical design approaches (design of experiments). A few examples are presented to explain the platform approach for purification development in more detail.
Feb 02, 2007
BioPharm International
Affinity purification schemes for antibody production have certain limitations keeping up with cell culture expression levels as they reach and exceed 10 g/L. New downstream purification processes are based on low cost, long lasting, and high binding (40–100 mg/mL) cation exchange resins.
Jan 01, 2007
BioPharm International
By BioPharm International Editors
The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
Jun 02, 2006
BioPharm International
By BioPharm International Editors
Downstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.
Apr 01, 2006
BioPharm International
In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.
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