Ivan L Budyak
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Explore the profile of Ivan L Budyak including associated specialties, affiliations and a list of published articles.
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18
Citations
58
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Recent Articles
1.
Lehman S, Vreeland W, Blaszczyk A, Adams-Hall S, Ahuja S, Arnaout A, et al.
Hum Gene Ther
. 2024 Dec;
36(1-2):36-44.
PMID: 39723438
Recombinant adeno-associated virus (AAV) is one of the main viral vector-based gene therapy platforms. AAV is a virus consisting of a ≈25 nm diameter capsid with a ≈4.7 kb cargo...
2.
Budyak I, Huang L, Dukor R
J Pharm Sci
. 2024 May;
113(8):2651-2655.
PMID: 38750935
Characterization and understanding of protein higher order structure (HOS) is essential at all stages of biologics development. Here, two folding variants of a bispecific monoclonal antibody, the correctly folded form...
3.
Saggu M, Bou-Assaf G, Bucher R, Budyak I, Buecheler J, Cao S, et al.
J Pharm Sci
. 2024 Jan;
113(5):1401-1414.
PMID: 38220088
Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these...
4.
Yang J, Ostafe R, Welch C, Verhalen B, Budyak I, Bruening M
Anal Chem
. 2023 May;
95(22):8541-8551.
PMID: 37216615
Therapeutic monoclonal antibodies (mAbs) provide effective treatments for many diseases, including cancer, autoimmune disorders, and, lately, COVID-19. Monitoring the concentrations of mAbs is important during their production and subsequent processing....
5.
Shahfar H, OBrien C, Budyak I, Roberts C
Mol Pharm
. 2022 Oct;
19(11):3820-3830.
PMID: 36194430
Static light scattering (SLS) was used to characterize five monoclonal antibodies (MAbs) as a function of total ionic strength (TIS) at pH values between 5.5 and 7.0. Second osmotic virial...
6.
Bou-Assaf G, Budyak I, Brenowitz M, Day E, Hayes D, Hill J, et al.
J Pharm Sci
. 2022 Jan;
111(7):2121-2133.
PMID: 34986360
Analytical ultracentrifugation (AUC) is a critical analytical tool supporting the development and manufacture of protein therapeutics. AUC is routinely used as an assay orthogonal to size exclusion chromatography for aggregate...
7.
Scannell M, Hyatt M, Budyak I, Woldeyes M, Wang Y
Pharm Res
. 2021 Oct;
38(11):1947-1960.
PMID: 34647231
Purpose: Protein solubility is an important attribute of pharmaceutical monoclonal antibody (MAb) formulations, particularly at high MAb concentrations. PEG-induced protein precipitation has been routinely used to assess protein solubility. To...
8.
Doyle B, Rauk A, Weiss 4th W, Budyak I
Anal Biochem
. 2020 Jul;
605:113837.
PMID: 32702436
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is routinely used for quantitation of soluble aggregates as an orthogonal technique to size-exclusion chromatography (SEC). SV-AUC presents many advantages over the SEC, yet lower...
9.
Doyle B, Budyak I, Rauk A, Weiss 4th W
Anal Biochem
. 2017 May;
531:16-19.
PMID: 28529050
Appropriate characterization of soluble aggregates is an important aspect of biologics development and manufacturing, and sedimentation velocity analytical ultracentrifugation (SV-AUC) is often used an orthogonal technique to size-exclusion chromatography (SEC)...
10.
Budyak I, Griffiths K, Weiss 4th W
Anal Biochem
. 2016 Aug;
513:36-38.
PMID: 27567991
Throughout the course of drug development there are many instances in which a variability assessment within a set of analytical data is required, which may be challenging for techniques that...