20-09-2018 дата публикации
Номер: US20180265543A1
The present disclosure relates generally to methods of producing, processing, or purifying antibodies. The present disclosure also relates to methods of producing, processing, or purifying a target antibody from cell cultures to remove host cell proteins. 1. A method for purifying , producing , processing , or isolating an antibody from a mixture comprising the antibody , the method comprising:a) loading the mixture onto protein A chromatography;b) washing the chromatography with at least one wash solution, wherein the at least one wash solution comprises from about 500 mM to about 8000 mM urea; andc) eluting with an elution buffer to obtain the antibody.2. The method of claim 1 , wherein the at least one wash solution further comprises arginine claim 1 , guanidine claim 1 , sodium chloride (NaCl) claim 1 , caprylate claim 1 , or combination thereof.3. The method of claim 2 , wherein the at least one wash solution comprises from about 100 mM to 1000 mM arginine claim 2 , from about 500 mM to about 1000 mM guanidine claim 2 , from about 500 mM to about 1500 mM NaCl claim 2 , from about 1 mM to about 50 mM caprylate claim 2 , or combination thereof.4. The method of claim 1 , wherein the at least one wash solution is at a pH from about 5.0 to about 8.5.5. The method of claim 1 , wherein the elution buffer comprises from about 5 mM to about 65 mM acetic acid.6. The method of claim 1 , wherein the elution buffer is at a pH of about 2.5 to about 3.5.7. The method of claim 1 , wherein the washing step is carried out at a flow rate of about 50 cm/hr to about 400 cm/hr.8. The method of claim 1 , wherein the washing step is repeated at least one claim 1 , two claim 1 , three claim 1 , or four times.9. The method of claim 1 , further comprising viral inactivation.10. The method of claim 9 , wherein the viral inactivation is conducted at a pH below 4.0 for at least 30 minutes.11. The method of claim 1 , further comprising depth filtration claim 1 , membrane filtration claim 1 , ...
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