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Sequence analysis of therapeutic monoclonal antibody
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Lian-quan QI, Yu BAI, Jian-hui LUO*
Acta Pharmaceutica Sinica | 2019, 54(11) : 2113 - 2117
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Acta Pharmaceutica Sinica | 2019, 54(11): 2113-2117
New Drug Forum
Sequence analysis of therapeutic monoclonal antibody
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Lian-quan QI, Yu BAI, Jian-hui LUO*
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2019-11-12 doi: 10.16438/j.0513-4870.2019-0255
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Sequence analysis of DNA, mRNA and protein is an essential component of biologics or bioprocess development. Analysis of sequences at the DNA, mRNA, and protein levels after the transfer of the gene of interest into a host cell is an important part of quality control. This article reviews the application of new technologies such as next-generation sequencing and LC-MS/MS in biological drug development such as monoclonal antibodies. These techniques have different requirements in term of cost, handling time and expertise. Selecting an appropriate technique with a sound rationale at different stages of drug development will add to the success rate of research and development, and ensure product quality, thus ensuring the clinical efficacy and safety.

sequence analysis  /  monoclonal antibody  /  mass spectrometry  /  next generation sequencing
Lian-quan QI, Yu BAI, Jian-hui LUO. Sequence analysis of therapeutic monoclonal antibody[J]. Acta Pharmaceutica Sinica, 2019 , 54 (11) : 2113 -2117 . DOI: 10.16438/j.0513-4870.2019-0255
Year 2019 volume 54 Issue 11
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Article Info
doi: 10.16438/j.0513-4870.2019-0255
  • Receive Date:2019-04-08
  • Online Date:2026-01-26
  • Published:2019-11-12
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  • Received:2019-04-08
  • Revised:2019-05-11
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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