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Page 1
CMC Regulatory Considerations for Antibody-Drug Conjugates.
Bechtold-Peters K, Ruggiero A, Vriezen N, Ihle N, Klein A, Morgan C, Schweizer D, Liu D, Jacobson F, Buecheler J, Panek M, Duggan N, Malyala P, Dupraz P, Desai P, Niu S, Feng Y, Wang X. Bechtold-Peters K, et al. Among authors: malyala p. J Pharm Sci. 2023 Dec;112(12):2965-2980. doi: 10.1016/j.xphs.2023.09.007. Epub 2023 Sep 21. J Pharm Sci. 2023. PMID: 37741455 Review.
GalNAc-Lipid nanoparticles enable non-LDLR dependent hepatic delivery of a CRISPR base editing therapy.
Kasiewicz LN, Biswas S, Beach A, Ren H, Dutta C, Mazzola AM, Rohde E, Chadwick A, Cheng C, Garcia SP, Iyer S, Matsumoto Y, Khera AV, Musunuru K, Kathiresan S, Malyala P, Rajeev KG, Bellinger AM. Kasiewicz LN, et al. Among authors: malyala p. Nat Commun. 2023 May 15;14(1):2776. doi: 10.1038/s41467-023-37465-1. Nat Commun. 2023. PMID: 37188660 Free PMC article.
In vivo CRISPR base editing of PCSK9 durably lowers cholesterol in primates.
Musunuru K, Chadwick AC, Mizoguchi T, Garcia SP, DeNizio JE, Reiss CW, Wang K, Iyer S, Dutta C, Clendaniel V, Amaonye M, Beach A, Berth K, Biswas S, Braun MC, Chen HM, Colace TV, Ganey JD, Gangopadhyay SA, Garrity R, Kasiewicz LN, Lavoie J, Madsen JA, Matsumoto Y, Mazzola AM, Nasrullah YS, Nneji J, Ren H, Sanjeev A, Shay M, Stahley MR, Fan SHY, Tam YK, Gaudelli NM, Ciaramella G, Stolz LE, Malyala P, Cheng CJ, Rajeev KG, Rohde E, Bellinger AM, Kathiresan S. Musunuru K, et al. Among authors: malyala p. Nature. 2021 May;593(7859):429-434. doi: 10.1038/s41586-021-03534-y. Epub 2021 May 19. Nature. 2021. PMID: 34012082
Generation and characterization of a bivalent protein boost for future clinical trials: HIV-1 subtypes CR01_AE and B gp120 antigens with a potent adjuvant.
Wen Y, Trinh HV, Linton CE, Tani C, Norais N, Martinez-Guzman D, Ramesh P, Sun Y, Situ F, Karaca-Griffin S, Hamlin C, Onkar S, Tian S, Hilt S, Malyala P, Lodaya R, Li N, Otten G, Palladino G, Friedrich K, Aggarwal Y, LaBranche C, Duffy R, Shen X, Tomaras GD, Montefiori DC, Fulp W, Gottardo R, Burke B, Ulmer JB, Zolla-Pazner S, Liao HX, Haynes BF, Michael NL, Kim JH, Rao M, O'Connell RJ, Carfi A, Barnett SW. Wen Y, et al. Among authors: malyala p. PLoS One. 2018 Apr 26;13(4):e0194266. doi: 10.1371/journal.pone.0194266. eCollection 2018. PLoS One. 2018. PMID: 29698406 Free PMC article.
Innate transcriptional effects by adjuvants on the magnitude, quality, and durability of HIV envelope responses in NHPs.
Francica JR, Zak DE, Linde C, Siena E, Johnson C, Juraska M, Yates NL, Gunn B, De Gregorio E, Flynn BJ, Valiante NM, Malyala P, Barnett SW, Sarkar P, Singh M, Jain S, Ackerman M, Alam M, Ferrari G, Salazar A, Tomaras GD, O'Hagan DT, Aderem A, Alter G, Seder RA. Francica JR, et al. Among authors: malyala p. Blood Adv. 2017 Nov 17;1(25):2329-2342. doi: 10.1182/bloodadvances.2017011411. eCollection 2017 Nov 28. Blood Adv. 2017. PMID: 29296883 Free PMC article.
Gaps in knowledge and prospects for research of adjuvanted vaccines.
Seder R, Reed SG, O'Hagan D, Malyala P, D'Oro U, Laera D, Abrignani S, Cerundolo V, Steinman L, Bertholet S. Seder R, et al. Among authors: malyala p. Vaccine. 2015 Jun 8;33 Suppl 2:B40-3. doi: 10.1016/j.vaccine.2015.03.057. Vaccine. 2015. PMID: 26022566
Analysis of immunoglobulin transcripts and hypermutation following SHIV(AD8) infection and protein-plus-adjuvant immunization.
Francica JR, Sheng Z, Zhang Z, Nishimura Y, Shingai M, Ramesh A, Keele BF, Schmidt SD, Flynn BJ, Darko S, Lynch RM, Yamamoto T, Matus-Nicodemos R, Wolinsky D; NISC Comparative Sequencing Program; Nason M, Valiante NM, Malyala P, De Gregorio E, Barnett SW, Singh M, O'Hagan DT, Koup RA, Mascola JR, Martin MA, Kepler TB, Douek DC, Shapiro L, Seder RA. Francica JR, et al. Among authors: malyala p. Nat Commun. 2015 Apr 10;6:6565. doi: 10.1038/ncomms7565. Nat Commun. 2015. PMID: 25858157 Free PMC article.
23 results