The discovery of numerous potent and broad neutralizing antibodies (bNAbs) against\nHuman Immunodeficiency Virus type 1 (HIV-1) envelope glycoprotein has invigorated the potential\nof using them as an effective preventative and therapeutic agent. The majority of the anti-HIV-1\nantibodies, currently under clinical investigation, are formulated singly for intra-venous (IV) infusion.\nHowever, due to the high degree of genetic variability in the case of HIV-1, a single broad neutralizing\nantibody will likely not be suffcient to protect against the broad range of viral isolates. To that end,\ndelivery of two or more co-formulated bnAbs against HIV-1 in a single subcutaneous (SC) injection\nis highly desired. We, therefore, co-formulated two anti-HIV bnAbs, 3BNC117-LS and 10-1074-LS,\nto a total concentration of 150 mg/mL for SC administration and analyzed them using a panel of\nanalytical techniques. Chromatographic based methods, such as RP-HPLC, CEX-HPLC, SEC-HPLC,\nwere developed to ensure separation and detection of each antibody in the co-formulated sample.\nIn addition, we used a panel of diverse pseudoviruses to detect the functionality of individual\nantibodies in the co-formulation. We also used these methods to test the stability of the co-formulated\nantibodies and believe that such an approach can support future efforts towards the formulation and\ncharacterization of multiple high-concentration antibodies for SC delivery.
Loading....