Protein A Resin Is Used to Remove Impurities From the Purified mAbs

Protein A Resin

Protein A resin is a type of chromatography medium used in the purification of monoclonal antibodies (mAbs) and other immunoglobulins. It was first discovered in the 1960s by a group of scientists at the University of Stockholm, who isolated it from the cell wall of the bacteria Staphylococcus aureus. Since then, Protein resin has become a standard technology in the biopharmaceutical industry for the production of mAbs.

Protein A resin has unique properties that make it ideal for the purification of mAbs. It selectively binds to the Fc region of immunoglobulins, which is the constant region that does not vary between different mAbs, and separates them from other components in a sample. This selectivity allows for high yields of purified mAbs with high purity and quality. In addition, Protein resin is a robust and scalable technology that can handle large volumes of starting material and can be used in various stages of the mAb production process. There are different types of Protein resins available, including natural and recombinant versions, with different binding capacities and selectivities. The choice of Protein resin depends on the characteristics of the mAb and the specific requirements of the purification process.

The global Protein A Resin Market was valued at US$ 474.0 Mn in 2019 and is forecast to reach a value of US$ 907.3 Mn by 2027 at a CAGR of 8.5% between 2020 and 2027.

Protein resin is used in various stages of the mAb production process, as described below: In the capture step, Protein resin is used to isolate mAbs from the starting material, which can be a complex mixture of proteins, such as cell culture supernatants or ascites fluid. The starting material is loaded onto a column containing Protein resin, which binds to the Fc region of IgG. Non-specific components are washed away, and the bound mAbs are eluted from the column using a low-pH buffer or other elution methods. The eluted mAbs are further purified in subsequent chromatography steps to remove remaining impurities.

In the polishing step, Protein A Resin is used to remove impurities from the purified mAbs. This is often the final step in mAb purification and is critical for achieving the desired purity and quality of the final product. Impurities, such as host cell proteins, DNA, and aggregates, can affect the efficacy and safety of the mAb and must be removed to meet regulatory standards. Protein resin can be used in polishing steps to remove these impurities by selectively binding and removing residual mAbs and other proteins. Protein resin is also used in formulation development of mAbs. Formulation development involves determining the best conditions for storing and delivering the mAb, such as buffer composition, pH, and preservatives. Protein resin is used to assess the stability of the mAb under different conditions, such as exposure to heat, light, or different pH levels. This information is used to optimize the formulation of the mAb for commercial production and delivery to patients. Protein resin is also used in quality control of mAbs. 

Quality control involves testing the final product for purity, potency, and safety before it is released for commercial use. Protein resin can be used in quality control assays to determine the concentration of mAbs in a sample and to assess the purity of the mAb by measuring the amount of residual impurities. These assays are critical for ensuring that the final product meets regulatory standards and is safe and effective for patients.