Purification of Factor Xlll Polypeptides From Biological Materials

A method for purifying a factor XIII polypeptide from a biological material comprising:

• (a) subjecting a biological material comprising a factor XIII polypeptide to chromatography on a first anion-exchange chromatographic material, said chromatography comprising:
• (i) applying said biological material to said first anion-exchange chromatographic material;
• (ii) eluting unbound material from the first anion-exchange chromatographic material with a buffer A comprising one or more stabilizing agents selected from sugars, alcohols, and alditols which are capable of increasing the stability of the factor XIII polypeptide, which buffer A is suitable for eluting material not bound to the first anion-exchange chromatographic material;
• and
• (iii) eluting said factor XIII polypeptide from the first anion-exchange chromatographic material by gradient-elution with buffer A′, which buffer A′ is suitable for eluting said factor XIII polypeptide from said first anion-exchange chromatographic material;
• and
• (b) subjecting the eluate from step (iii), or a fluid prepared by use of the eluate from step (iii), to chromatography using a hydrophobic interaction chromatographic material, said chromatography comprising:
• (iv) applying the eluate from step (iii), or a fluid prepared by use of the eluate from step (iii), to said hydrophobic interaction chromatographic material;
• (v) eluting unbound material from the chromatographic material with buffer B, which buffer B is suitable for eluting material not bound to the hydrophobic interaction chromatographic material;
• and
• (vi) eluting said factor XIII polypeptide from said chromatographic material by gradient-elution with buffer B′, which buffer B′ is suitable for eluting factor XIII from said hydrophobic interaction chromatographic material.