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Open AccessArticle

Characterization of Co-Formulated High-Concentration Broadly Neutralizing Anti-HIV-1 Monoclonal Antibodies for Subcutaneous Administration

1
IAVI, 125 Broad Street, New York, NY 10004, USA
2
CuriRx, Inc., 205 Lowell Street, Wilmington, MA 01887, USA
3
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA
4
Laboratory of Molecular Immunology, The Rockefeller University, New York, NY 10065, USA
5
Howard Hughes Medical Institute, The Rockefeller University, New York, NY 10065, USA
*
Author to whom correspondence should be addressed.
Both authors contributed equally to the work.
Antibodies 2020, 9(3), 36; https://doi.org/10.3390/antib9030036
Received: 26 June 2020 / Revised: 21 July 2020 / Accepted: 23 July 2020 / Published: 29 July 2020
(This article belongs to the Special Issue Monoclonal Antibody-Directed Therapy)
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. View Full-Text
Keywords: HIV/AIDS; co-formulation; high concentration; analytical characterization; antibody (s) HIV/AIDS; co-formulation; high concentration; analytical characterization; antibody (s)
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MDPI and ACS Style

Sharma, V.K.; Misra, B.; McManus, K.T.; Avula, S.; Nellaiappan, K.; Caskey, M.; Horowitz, J.; Nussenzweig, M.C.; Seaman, M.S.; Javeri, I.; Dey, A.K. Characterization of Co-Formulated High-Concentration Broadly Neutralizing Anti-HIV-1 Monoclonal Antibodies for Subcutaneous Administration. Antibodies 2020, 9, 36. https://doi.org/10.3390/antib9030036

AMA Style

Sharma VK, Misra B, McManus KT, Avula S, Nellaiappan K, Caskey M, Horowitz J, Nussenzweig MC, Seaman MS, Javeri I, Dey AK. Characterization of Co-Formulated High-Concentration Broadly Neutralizing Anti-HIV-1 Monoclonal Antibodies for Subcutaneous Administration. Antibodies. 2020; 9(3):36. https://doi.org/10.3390/antib9030036

Chicago/Turabian Style

Sharma, Vaneet K.; Misra, Bijay; McManus, Kevin T.; Avula, Sreenivas; Nellaiappan, Kaliappanadar; Caskey, Marina; Horowitz, Jill; Nussenzweig, Michel C.; Seaman, Michael S.; Javeri, Indu; Dey, Antu K. 2020. "Characterization of Co-Formulated High-Concentration Broadly Neutralizing Anti-HIV-1 Monoclonal Antibodies for Subcutaneous Administration" Antibodies 9, no. 3: 36. https://doi.org/10.3390/antib9030036

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