Protein A affinity chromatography is the key capture method in monoclonal antibody (mAb) purification and the quality of the resin is key to the whole process. Geert Lissens, Sales Manager Europe at JSR Life Sciences, explains, “the selection of an appropriate Protein A resin has direct implications on the overall process economics of mAb production, be it on the media expense, buffer consumption, labour time or productivity.”
But what makes a good resin? Lissens describes how “state-of-the-art resins must offer good specificity, high mass transfer and binding capacity, low non-specific adsorption, low ligand leakage, suitable back pressure under high flow operation, and good chemical stability – particularly during alkaline sanitization.”
With these attributes in mind, JSR Life Sciences developed ‘Amsphere™ A3’, launching the novel Protein-A bioprocess media for therapeutic protein purification in January this year. Lissens explains it is a “platform-ready resin with outstanding DBC and improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime.”
This is based on customer data gathered over the last 9 months on more than 25 mAbs from over 20 different biotech companies, with results that demonstrate DBC of up to 70 g/Liter and excellent impurity clearance. A3 is also very suited for fragment purification: DBCs up to 20-30g/L can be achieved based on a binding of Protein-A to the VH-region of fragments.
“Platform purification also implies that the media can easily be used at large scale with consistent packing performance and pressure flow behaviour that enables users to apply high flow velocities. The resin can be run in manufacturing scale columns at high flow rates up to 400 cm/hour at 20 cm bed height” Lissens adds.
Geert Lissens is speaking on ‘Platform Purification of Antibodies using the HighCapacity Amsphere™ A3 Protein A Resin’ at BioProcess International Europe. He will give insights into the selection of ligand design, bead design and surface modification, as well as presenting three different scenarios that show the distinct benefits Amsphere™ A3 offers.