Repligen is a leading large-scale manufacturer of Protein A, a critical reagent used in the production of monoclonal antibody therapeutics. We manufacture and sell multiple forms of bulk Protein A under long term supply agreements with large life sciences companies. These customers incorporate Protein A into their chromatography media products that they in turn sell to biopharmaceutical companies for the production of monoclonal antibodies. Use of Protein A chromatography media is recognized as the established standard for highly efficient purification of monoclonal antibodies. Demand for Protein A is driven by the continued growth of the monoclonal antibody therapeutics market. Over 30 monoclonal antibodies are currently approved for commercialization, and an industry pipeline of over 300 monoclonal antibodies in clinical development is expected to generate additional approvals and global market expansion.
Our growth factor products are used to increase productivity during the fermentation (cell culture) stage of manufacturing biologic drugs. The use of growth factors results in improved yield of the final drug product. We obtained our growth factors through the acquisition of Repligen Sweden AB, and we expect this product line to benefit from increased market demand for cell culture supplements. Our primary growth factor product is LONG ®R3IGF-1, a more biologically potent alternative to recombinant insulin. Repligen’s growth factor products are currently used in the manufacture of nine biologic drugs approved by the U.S. Food and Drug Administration (FDA).
Our proprietary chromatography products are sold directly to biopharmaceutical manufacturers. These products are utilized during the purification and quality control stages of biomanufacturing and include Repligen’s Protein A affinity chromatography media, our pre-packed OPUS ® chromatography columns and our Protein A ELISA test kits. In the area of purification, we currently offer three types of Protein A media that are used in the manufacture of several approved monoclonal antibodies. We also sell our OPUS ® pre-packed chromatography columns as a disposable technology alternative for manufacturers of clinical-stage or niche commercial biologics. In the area of quality control, our ELISA test kits are used to ensure the purity of monoclonal antibody products by detecting any leached Protein A during process monitoring and final product testing.
In total, we have a portfolio of over 15 bioprocessing products, many of which have been incorporated into established biopharmaceutical manufacturing processes. Consistent with our focus on the growth of our bioprocessing business, we are currently exploring opportunities to acquire synergistic bioprocessing companies and/or consumable bioprocessing products.