期刊
ANTIBODIES
卷 9, 期 3, 页码 -出版社
MDPI
DOI: 10.3390/antib9030036
关键词
HIV; AIDS; co-formulation; high concentration; analytical characterization; antibody (s)
类别
资金
- Bill and Melinda Gates Foundation (BMGF) Collaboration for AIDS Vaccine Development (CAVD) [OPP1147661, OPP1153692, OPP1146996]
- Bill and Melinda Gates Foundation [OPP1153692, OPP1147661] Funding Source: Bill and Melinda Gates Foundation
The discovery of numerous potent and broad neutralizing antibodies (bNAbs) against Human Immunodeficiency Virus type 1 (HIV-1) envelope glycoprotein has invigorated the potential of using them as an effective preventative and therapeutic agent. The majority of the anti-HIV-1 antibodies, currently under clinical investigation, are formulated singly for intra-venous (IV) infusion. However, due to the high degree of genetic variability in the case of HIV-1, a single broad neutralizing antibody will likely not be sufficient to protect against the broad range of viral isolates. To that end, delivery of two or more co-formulated bnAbs against HIV-1 in a single subcutaneous (SC) injection is highly desired. We, therefore, co-formulated two anti-HIV bnAbs, 3BNC117-LS and 10-1074-LS, to a total concentration of 150 mg/mL for SC administration and analyzed them using a panel of analytical techniques. Chromatographic based methods, such as RP-HPLC, CEX-HPLC, SEC-HPLC, were developed to ensure separation and detection of each antibody in the co-formulated sample. In addition, we used a panel of diverse pseudoviruses to detect the functionality of individual antibodies in the co-formulation. We also used these methods to test the stability of the co-formulated antibodies and believe that such an approach can support future efforts towards the formulation and characterization of multiple high-concentration antibodies for SC delivery.
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