Understanding the process-induced formation of minor conformational variants of Erwinia chrysanthemi l-asparaginase

What is it about?

Erwinia chrysanthemi L-asparaginase (ErA) is an enzyme, used as treatment for childhood leukaemia. When it is manufactured, certain conditions during processing may force a small proportion of the enzyme to change shape very slightly. The resulting materials are still efficacious and active, but needed to be understood in terms of control of the manufacture. Our paper shows how to control the formation of these shape (conformational) variants of the enzyme during manufacture.

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Why is it important?

Regulators expect that biopharmaceutical manufacturers must continuously improve their manufacturing processes. Our paper shows our efforts to do this. It is quite likely than many proteins and enzymes used as medicines undergo these slight changes, and other manufacturers will be expected to characterise and understand them.

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