Enabling Purification Solutions - 2nd Generation Biologicals

The high resolution separation power of the ContiChrom platform in conjunction with its process economics allows considering the development of 2nd generation products with superior quality characteristics that translate into better safety and/or efficacy product profiles. In one example, an existing API consisting of several isoforms is being developed into a second generation product that has a higher potency and lower related impurities. Most of the upstream process did not change and the process economics was very favorable. In another example, a first generation product was transformed into a 2 nd generation product by PEGylation. Typically, PEGylation is performed on purified API and the PEGylated species have to be further purified, leading to substantial product losses and resulting unfavorable process economics. Employing the Contichrom technology, the product purity and yield could be significantly improved leading to a great improvement of the COG and OPEX.

Examples where the ContiChrom platform has been useful:

•  Monoclonal antibody variant fractionation

•  Bi-specific antibody purification

•  Glycoprotein fractionation

•  Fractionation of IVIGs

•  Generation of high purity omega fatty acids for pharmaceutical use