Characterization of Therapeutic Proteins

Struble, Evi; Kirschbaum, N.; Liu, J.; Marszal, Ewa; Shapiro, Marjorie A.

doi:10.1007/7355_2015_5005

Cited by 6 publications

(6 citation statements)

References 172 publications

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“…A similar study on controlled crystallization was not performed with dexamethasone to the best of our knowledge. However, it was shown that when dexamethasone is combined with poly(dodecyl methacrylate), the polymer may act as a nucleation site to form a crystalline drug form [ 46 ]. It should be noted that the study [ 46 ] was performed on thin films of polymer/drug mixtures.…”

Section: Resultsmentioning

confidence: 99%

“…Polymer and Dexa powders spectra were analyzed to identify specific vibration modes for Dexa. Dexamethasone amorphous and crystalline phase was distinguished as described in ref [ 46 ]. Raman spectrum of Dexa in an amorphous phase was obtained from ethanolic Dexa solution (1 mg·mL −1 ).…”

Section: Methodsmentioning

confidence: 99%

“…However, it was shown that when dexamethasone is combined with poly(dodecyl methacrylate), the polymer may act as a nucleation site to form a crystalline drug form [46]. It should be noted that the study [46] was performed on thin films of polymer/drug mixtures. The morphology of the microparticles from P1 copolymer (10 mg•mL −1 ) and Dexa (2 mg•mL −1 ) in a dried state was studied by scanning electron microscopy (SEM) and wide-angle X-ray scattering (WAXS) methods (Figure 7a-c).…”

Section: Formation Of Microparticles In P1 Copolymer/dexa Solutionsmentioning

confidence: 99%

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Effect of Dexamethasone on Thermoresponsive Behavior of Poly(2-Oxazoline) Diblock Copolymers

et al. 2021

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Thermoresponsive polymers play an important role in designing drug delivery systems for biomedical applications. In this contribution, the effect of encapsulated hydrophobic drug dexamethasone on thermoresponsive behavior of diblock copolymers was studied. A small series of diblock copoly(2-oxazoline)s was prepared by combining thermoresponsive 2-n-propyl-2-oxazoline (nPrOx) and hydrophilic 2-methyl-2-oxazoline (MeOx) in two ratios and two polymer chain lengths. The addition of dexamethasone affected the thermoresponsive behavior of one of the copolymers, nPrOx20-MeOx180, in the aqueous medium by shifting the cloud point temperature to lower values. In addition, the formation of microparticles containing dexamethasone was observed during the heating of the samples. The morphology and number of microparticles were affected by the structure and concentration of copolymer, the drug concentration, and the temperature. The crystalline nature of formed microparticles was confirmed by polarized light microscopy, confocal Raman microscopy, and wide-angle X-ray scattering. The results demonstrate the importance of studying drug/polymer interactions for the future development of thermoresponsive drug carriers.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Formation Of Microparticles In P1 Copolymer/dexa Solutionsmentioning

confidence: 99%

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Effect of Dexamethasone on Thermoresponsive Behavior of Poly(2-Oxazoline) Diblock Copolymers

et al. 2021

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“…In contrast, each monoclonal product contains a single kind of pathogen-specific antibody made from the culturing of mammalian cells at industrial scale. Differences in the post-translational modifications and other productionrelated factors notwithstanding [49], all the molecules in such preparations have the same sequence, structure and function.…”

Section: Immune Prophylaxis and Therapymentioning

confidence: 99%

Immune Prophylaxis and Therapy for Human Cytomegalovirus Infection

Struble¹,

Murata

Komatsu

et al. 2021

IJMS

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Human Cytomegalovirus (HCMV) infection is widespread and can result in severe sequelae in susceptible populations. Primary HCMV infection of naïve individuals results in life-long latency characterized by frequent and sporadic reactivations. HCMV infection elicits a robust antibody response, including neutralizing antibodies that can block the infection of susceptible cells in vitro and in vivo. Thus, antibody products and vaccines hold great promise for the prevention and treatment of HCMV, but to date, most attempts to demonstrate their safety and efficacy in clinical trials have been unsuccessful. In this review we summarize publicly available data on these products and highlight new developments and approaches that could assist in successful translation of HCMV immunotherapies.

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“…Some of these variants have been reported to cause reduced efficacy or side effects. 8 During manufacturing process development, examples of sequence mutations and terminal peptide truncation have been reported. 9 Thus, it is of high importance to develop robust analytical methods to accurately measure these variants in support of monoclonal antibody manufacturing and finished product characterization.…”

Section: Introductionmentioning

confidence: 99%

Antibody characterization using novel ERLIC-MS/MS-based peptide mapping

Jing

Kim²,

Zhou³

et al. 2018

mAbs

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Electrostatic repulsion hydrophilic interaction chromatography (ERLIC) coupled with mass spectrometry (MS) is a technique that is increasingly being used as a trapping/enrichment tool for glycopeptides/phosphorylated peptides or sample fractionation in proteomics research. Here, we describe a novel ERLIC-MS/MS-based peptide mapping method that was successfully used for the characterization of denosumab, in particular the analysis of sequence coverage, terminal peptides, methionine oxidation, asparagine deamidation and glycopeptides. Compared to reversed phase liquid chromatography (RPLC)-MS/MS methods, ERLIC demonstrated unique advantages in the retention of small peptides, resulting in 100% sequence coverage for both the light and heavy chains. It also demonstrated superior performance in the separation and characterization of asparagine deamidated peptides, which is known to be challenging by RPLC-MS/MS. The developed method can be used alone for peptide mapping-based characterization of monoclonal antibodies, or as an orthogonal method to complement the RPLC-MS/MS method. This study extends the applications of ERLIC from that of a trapping/fractioning column to biologic therapeutics characterization. The ERLIC-MS/MS method can enhance biologic therapeutics analysis with more reliability and confidence for bottom-up peptide mapping-based characterization.

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Characterization of Therapeutic Proteins

Cited by 6 publications

References 172 publications

Effect of Dexamethasone on Thermoresponsive Behavior of Poly(2-Oxazoline) Diblock Copolymers

Effect of Dexamethasone on Thermoresponsive Behavior of Poly(2-Oxazoline) Diblock Copolymers

Immune Prophylaxis and Therapy for Human Cytomegalovirus Infection

Antibody characterization using novel ERLIC-MS/MS-based peptide mapping

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