The United States of America, As Represented by the Secretary, Department of Health and Human Services

United Therapeutics Corporation

Samir Hussein Shaban

George Mitra

Mary Koleck

David Meh

Timothy Atolagbe

Jianwei Zhu

Yueqing Xie

Trevor Lane Broadt

G Mark Farquharson

Gerald M Farquharson

Jianwei Sean Zhu

Described are improved processes for production and purification of nucleic acid-containing compositions, such as non-naturally occurring viruses, for example, recombinant polioviruses that can be employed as oncolytic agents. Some of the described improved processes relate to improved processes for producing viral DNA template. Also described are improved processes for chromatography purification of nucleic acid-containing compositions, in which the nucleic acid is quantified in chromatography fractions using a rapid detection method of the one or more nucleic acid sequences of the nucleic acid-containing composition, such as detection by real time RT-qPCR. In addition, improved processes for production and purification of oncolytic poliovirus, such as PVS-RIPO, are described. Compositions generated using these methods are also provided.

Processes for production and purification of nucleic acid-containing compositions

Disclosed here includes a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method disclosed here can be particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).

Method for purifying antibodies

Method for purifying antibodies using PBS

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Ashburn, VA, United States of America

Samir Hussein Shaban