Page 63 - Pharmaceutical- Guide to Biopharmaceutical

References:

Culture

p. 12_Monitoring of Metal Elements in Cell Culture Supernatant using Atomic Absorption Spectrometry Cell Line Optimization
1) Inn H Yuk et al., Biotechnology Progress, 30, 429-442 (2014)
2) Prabhu et al., Applied Microbiology and Biotechnology, 102, 5989-5999 (2018)
3) Application News A634 “Direct Analysis of Metallic Elements in Cell Culture Medium by Atomic Absorption Spectrophotometry (AAS)”
p. 14_Simultaneous Analysis of Components in CHO Cell Culture Supernatant for Optimization of the Culture Process
1) Zhiyuan Sun et al., Biologicals, 61, 144-51 (2019) Culture

Quality Control

p. 26_ Analysis of Protein Secondary Structures—Analysis on Changes of Secondary Structures in Egg White Proteins Caused by Thermal
Denaturation—
1) JENNIFER KOVACS-NOLAN, J. Agric. Food Chem., 53, 8421-8431 (2005)
2) Yoshinori Mine et. al., J. Agric. Food Chem., 38 (12), 2122–2125 (1990)
3) Jilie KONG, Shaoning YU., Acta Biochim. Biophys. Sin., 39(8), 549–559 (2007) Purification
4) A. Kato and T.Takagi, J. Agric. FoodChem., 36, 1156-1159 (1988)

p. 30_ N-Linked Glycan Analysis Using MALDImini-1—Structural Analysis and Identification of Sialyl Linkage Isomers
1) Nishikaze T, et al., Anal Chem, 89, 2353-2360 (2017)
2) Hanamatsu H, et al., Anal Chem, 90(22), 13193-13199 (2018)

p. 40_Characterization of Insoluble Subvisible Particles in Biopharmaceuticals Using the Flow Imaging Method
1) Susumu Uchiyama, Yakugaku Zasshi (Journal of the Pharmaceutical Society of Japan), 138, 1503-1507(2018)
2) Kiyoshi M et al., Journal of Pharmaceutical Sciences, 108, 832-841 (2019) Characterization

p. 44_Analysis by ICP Mass Spectrometry Specified in the ICH Q3D Guideline for Elemental Impurities
1) Guideline for Elemental Impurities in Drug Products (PFSB/ELD Notification No. 4, September 30, 2015)
2) GUIDELINE FOR ELEMENTAL IMPURITIES Q3D(R1)
3) Supplement II to the Japanese Pharmacopoeia 17th Edition (June 28, 2019, Ministry of Health, Labour and Welfare Notification No. 49)
Note: Currently, biopharmaceuticals are not subject to ICH Q3D.

Pharmacokinetics Quality Control

p. 48_LC/MS Bioanalysis of Antibody Drugs by nSMOL Fab-Specific Protein Analysis Method—Example of Trastuzumab Analysis—
1) Iwamoto N et. al., Analyst, DOI: 10.1039/c3an02104a
2) Iwamoto N et. al., Anal Methods, DOI:10.1039/c5ay01588j

p. 50_High-Sensitivity LC/MS Bioanalysis of Trastuzumab by nSMOL
1) Iwamoto N et.al., Analyst, DOI: 10.1039/c3an02104a Pharmacokinetics
2) Iwamoto N et al., Anal Methods, DOI: 10.1039/c5ay01588j
3) Application News C145A

p. 52_Comprehensive Analysis of All Metabolites Using GC/MS and LC/MS for Researching Intestinal Bacteria
1) M. Matsumoto, et al., Scientific Reports, 2, 223 (2012).

p. 56_Profiling Cancer Cells Using a Benchtop MALDI-TOF MS System Others
1) Stübiger, G. et al., Analytical Chemistry, 90, 13178-13182 (2018)

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