TOYOPEARL AF-rProtein A-650F affinity resin is well-suited for capturing of antibodies out of high titre feedstocks. It combines a high binding capacity at short residence time and fast mass transfer kinetics with alkaline stability.
TOYOPEARL AF-rProtein A-650F affinity resin is well-suited for capturing of antibodies out of high titre feedstocks. It combines a high binding capacity at short residence time and fast mass transfer kinetics with alkaline stability. The typical dynamic binding capacity for IgG is higher than 30 mg/mL resin at two minutes residence time. Thus, Toyopearl AF-rProtein A-650F offers the opportunity to improve process economics by increasing both, throughput and robustness. The high binding capacity helps to minimize the resin and buffer volumes needed for a given target load. Applying higher flow rates reduces loading and cycle times in lab scale and process scale purifications.
A newly developed recombinant ligand (non-animal-derived) has been engineered to maintain capacity even after repeated exposure to alkaline solution. Its multipoint attachment to the TOYOPEARL polymeric matrix further enhances chemical and thermal stability. In practice this pays off for a low level of protein A leaching and also for a high resistance to alkaline solutions employed in cleaning-in-place (CIP) procedures. As a consequence the number of cycles can be increased when compared to Protein A resins with lower caustic stability.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.