Articles

RSS

Click Here To Download:
•Article: DNA Clearance From Antibody Preparations Using Mustang Q Membrane - A Model Study

The world market demand for monoclonal IgG and recombinant protein is growing rapidly. Improvements in cell culture techniques have significantly improved the efficiency of production with concentrations of MAb over 1g per L being reported in hybridoma supernatants. However, during the cell growth and harvesting steps, a certain amount of nucleic acid may contaminate the product of interest. Nucleic acid contamination may come from the host cell DNA — genomic or vector — or it may come from retroviral RNA, which is considered a greater risk. Fragments of sizes larger than 2 kilobases are considered to be potentially carcinogenic, and therefore nucleic acids have to be removed from the final product. The FDA Center for Biological Evaluation and Research in the United States initially defined the maximum allowable nucleic acid contamination as 10 pg per dose. Meanwhile the World Health Organization stated that 100 pg per dose could be acceptable. A more recent "Point to Consider" from CBER states that "Lot to lot testing for DNA contents in biological products produced in cell lines should be performed and lot release limits established that reflect a level of purity that can be achieved reasonably and consistently." This all suggests that a rapid and cost-efficient method that clears nucleic acid to below acceptable (and ideally detectable) levels, is needed.

Click Here To Download:
•Article: DNA Clearance From Antibody Preparations Using Mustang Q Membrane - A Model Study

SOURCE: Pall Life Sciences

• Request Information
• Contact Details
• Company Profile