Newer cell based processes for production of influenza vaccines offer opportunities for flexible, rapid scalability of manufacturing that would be challenging with traditional egg based processes. For both egg based and cell based processes, regulatory authorities mandate that all vaccines undergo extensive release testing of the final product for potency, purity and safety. Although a variety of process templates exist, many of the traditional downstream operations, e.g., chromatography, used for purifying therapeutic proteins are of limited utility in vaccine manufacturing processes owing to the complexity of the processes and diversity of targets. Of particular importance is removal host cell impurities, such as nucleic acids, which co-purify with virus during the downstream processing. The World Health Organization (WHO) recommends the final product to be &lt; 10 ng/dose and &lt; 200 base pairs. EMD Millipore’s Benzonase® endonuclease can be successfully used during downstream processing to reduce the overall levels of nucleic acid impurities and limit the size of remaining nucleic acid fragments to &lt; 10 base pairs. In these studies, multiple variables [e.g., Benzonase® and Mg2+concentration, temperature] were evaluated to determine the impact on digestion of MDCK genomic DNA in influenza feed streams. Optimization of analytical methods will be described and their contribution to understanding best practices for Benzonase® implementation will be discussed.

Residual DNA removal by Benzonase® endonuclease in influenza feedstreams

251st National Meeting (2016)

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