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Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial

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*JP: 4826995, US: 8084032, 8435527, 2012-0264918, EP: 1568710, CN: 1680426 Features Enables effective elution of antibodies from protein A column, reducing potential risk of acid denaturation and resultant aggregation Virus inactivation, a key step of clinical antibody manufacturing, is enhanced by arginine The use of this product has no impact on the preceding processes of antibody purification, e.g., loading step of cell culture medium and the following column washing step Flexible customization of Arginine-based elution buffers on demand Elution from Protein A using L-Arginine Comparison with glycine-HCl elution buffer Procedure Equilibrate protein A column (here COSMOGEL Ig-Accept Protein A) with D-PBS Load human serum Wash with 10 column volumes of D-PBS Elute with 5 column volumes of acid (0.1 M glycine pH 2.8 - 4.0) or Arg-Antibody Elution Buffer Analyze eluted fractions by SDS-PAGE Results Arg-Antibody elution buffer shows much higher recovery (lane 6) than glycine buffer (lane 5)

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