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The biopharmaceutical industry has made significant strides in the production of biologic drugs. Biologic drugs differ from traditional small molecule drugs in that they are made from living organisms, such as bacteria, yeast, or mammalian cells. Biologic drugs are commonly used to treat chronic conditions, such as cancer and autoimmune diseases. Purification is a critical step in the manufacture of biopharmaceuticals to ensure that the final product meets the quality and safety standards required by regulatory agencies.
Antibodies are one of the largest classes of biologic drugs, and they are commonly used to treat cancer, autoimmune diseases, and infectious diseases. Antibody manufacturing involves the expression of antibodies in mammalian cells, followed by purification steps to isolate and characterize the desired antibody product.
Several innovative purification technologies have been developed to address the challenges of antibody purification. These technologies include:
HTPD is a process development approach that uses parallel screening of process conditions to optimize antibody purification. HTPD enables rapid optimization of purification conditions, reducing the time and cost of process development.
Single-use technologies, such as single-use bioreactors and chromatography columns, offer several advantages over traditional stainless steel equipment. Single-use technologies are more flexible and allow for rapid changeovers, reducing downtime between batches. They also eliminate the risk of cross-contamination, enhancing product purity and safety.
Continuous chromatography involves the use of a continuous resin bed to improve process efficiency and product yield. Continuous chromatography eliminates the need for column packing and unpacking, reducing the time and cost of purification.
Affinity precipitation is a novel purification approach that uses a dendrimer-based precipitation agent to selectively bind and remove impurities from the antibody product. Affinity precipitation offers high purity and yield, and it has the potential to reduce the cost of antibody production.
In summary, the biopharmaceutical industry continues to explore opportunities to improve the efficiency of biologic drug production. Antibody purification is a critical step in the manufacture of biologic drugs, and the development of new purification technologies has been essential in addressing the challenges of antibody purification. Advanced purification technologies, such as HTPD, single-use technologies, continuous chromatography, and affinity precipitation, have the potential to revolutionize antibody purification and improve the efficiency and safety of biologic drug production.
