Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Yin, Jian; Swartz, Trevor E.; Zhang, Jian; Patapoff, Thomas W.; Chen, Bartolo; Marhoul, Joseph; Shih, Norman; Kabakoff, Bruce; Rahimi, Kimia

doi:10.5731/pdajpst.2016.006494

Cited by 6 publications

(2 citation statements)

References 2 publications

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“…The absorption spectrum is the characteristic absorption curve of a material and is strictly consistent with molecular structure ( 30 ). The molecular structures of different materials have a unique spectrum.…”

Section: Resultsmentioning

confidence: 91%

Tracking of transplanted human umbilical cord-derived mesenchymal stem cells labeled with fluorescent probe in a mouse model of acute lung injury

Geng-long

et al. 2018

Int J Mol Med

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The aim of the present study was topreliminarily visualize the distribution of humanumbilical cord-derived-mesenchymal stem cells (hUC-MSCs) in treating acute lung injury (ALI) using a targeted fluorescent technique. Anovel fluorescent molecule probe was first synthesized via the specific binding of antigen and antibody in vitro to label the hUC-MSCs. Two groups of mice, comprising a normal saline (NS)+MSC group and lipopolysaccharide (LPS)+MSC group, were subjected to optical imaging. At 4 h following ALI mouse model construction, the labeled hUC-MSCs were transplanted into the mice in the NS+MSC group and LPS+MSC group by tail vein injection. The mice were sacrificed 30 min, 1 day, 3 days and 7 days following injection of the labeled hUC-MSCs, and the lungs, heart, spleen, kidneys and liver were removed. The excised lungs, heart, spleen, kidneys and liver were then detected on asmall animal fluorescent imager. The fluorescent results showed that the signal intensity in the lungs of the LPS+MSC group was significantly higher, compared with that of the NS+MSC group at 30 min (3.53±0.06×10−4, vs. 1.95±0.05×10−4 scaled counts/sec), 1 day (36.20±0.77×10−4, vs. 23.45±0.43×10−4 scaled counts/sec), 3 days (11.83±0.26×10−4, vs. 5.39±0.10×10−4 scaled counts/sec), and 7 days (3.14±0.04×10−4, vs. 0.00±0.00×10−4 scaled counts/sec; all P<0.05). The fluorescence intensity in the liver of the LPS+MSC group, vs. NS+MSC group was measured at 30 min (0.00±0.00×10−4, vs. 0.00±0.00×10−4 scaled counts/sec); 1 day (5.53±0.08×10−4, vs. 5.44±0.16×10−4 scaled counts/sec); 3 days (0.00±0.00×10−4, vs. 8.67±0.05×10−4 scaled counts/sec); 7 days (0.00±0.00×10−4, vs. 0.00±0.00×10−4 scaled counts/sec). The signal intensity of the heart, spleen and kidneys was minimal. In conclusion, the novel targeted fluorescence molecular probe was suitable for tracking the distribution processes of hUC-MSCs in treating ALI.

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Section: Resultsmentioning

confidence: 91%

Tracking of transplanted human umbilical cord-derived mesenchymal stem cells labeled with fluorescent probe in a mouse model of acute lung injury

Geng-long

et al. 2018

Int J Mol Med

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“…Validation of the tristimulus colorimetry approach in accordance to ICHQ2 (R1) guidance showed instrument, assay repeatability and intermediate precision of the method to be well below what is considered a visually perceptible color difference [34]. Under the experimental conditions, the spectral method was determined to yield results at least equivalents to those generated by visual assessment [34].…”

Section: Compendial and Characterization Methods For Determination Of The Color Of Protein Solutionsmentioning

confidence: 98%

The Different Colors of mAbs in Solution

Ambrogelly

2021

Antibodies

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The color of a therapeutic monoclonal antibody solution is a critical quality attribute. Consistency of color is typically assessed at time of release and during stability studies against preset criteria for late stage clinical and commercial products. A therapeutic protein solution’s color may be determined by visual inspection or by more quantitative methods as per the different geographical area compendia. The nature and intensity of the color of a therapeutic protein solution is typically determined relative to calibrated standards. This review covers the analytical methodologies used for determining the color of a protein solution and presents an overview of protein variants and impurities known to contribute to colored recombinant therapeutic protein solutions.

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Mechanisms of color formation in drug substance and mitigation strategies for the manufacture and storage of therapeutic proteins produced using mammalian cell culture

Cheng

Song

et al. 2019

Process Biochemistry

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Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Cited by 6 publications

References 2 publications

Tracking of transplanted human umbilical cord-derived mesenchymal stem cells labeled with fluorescent probe in a mouse model of acute lung injury

Tracking of transplanted human umbilical cord-derived mesenchymal stem cells labeled with fluorescent probe in a mouse model of acute lung injury

The Different Colors of mAbs in Solution

Mechanisms of color formation in drug substance and mitigation strategies for the manufacture and storage of therapeutic proteins produced using mammalian cell culture

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