Description
MabPolish is a special mixed-mode chromatography media having strong binding to a broad range of host cell proteins and other impurities but little binding to antibodies (typically >90% yield). It is designed for process scale production of monoclonal antibodies. Regulatory support files are available.
Application Guide
MabPolishTM Type I – Anion-exchange mixed-mode resin with very mild hydrophobicity. It can remove high level of HCPs at pH 4 to 5 and salt concentration up to 0.15 M.
MabPolishTM Type II – It is designed to remove high molecular weight species (HMWS) from monoclonal antibodies at pH 4 to 5 and salt concentration up to 0.15M.
MabPolishTM Type III – It has strong anion-exchange and hydrophobic groups for purifying antibodies in bind-elute mode if operational condition is optimised.
MabPolish can be used in flow-through mode to remove impurities from monoclonal antibodies or other antibody materials, at various stages of the whole antibody purification process. Examples of the possible application scenario could be:
- Direct removal of impurities from crude clarified antibody materials (using MabPolish Type I)
- After an antibody is first purified by affinity chromatography media (using MabPolish Type II or III);
- After an antibody is first purified by ion-exchangers (using MabPolish Type II);
- After an antibody is first processed through precipitation (using MabPolish Type I, II, III)
The base matrix is made of beaded agarose that has been highly cross-linked. The media is stable in most chemical conditions experienced in the bioprocessing industry.
MabPolish Selection Kit contains 1 ml each of MabPolish Type I, Type II, Type III, MabPolish DUO 150A, 150C.
Pre-packed columns for screening and process development use are available at following sizes: 1 ml, 5 ml, 3.8 ml (7x100mm ID x BH), 9.5 ml (11x100mm ID x BH), 20 ml (16x100mm ID x BH), 53 ml (26x100mm ID x BH). All these columns have connections fully compatible to Akta systems. Column hardware has 6 bar (0.6 MPa) pressure rating. See Column Instruction for details of HiSep and Optio column hardware.
Pre-packed columns for pilot to production scale use with column diameter ranging from 5cm to 45cm are available on request. For bulk loose media, please contact us.
This range of chromatography media is developed and supported for production scale chromatography use. Regulatory Support File (RSF) is available to assist process validation and submissions to regulatory authorities.