コンテンツへスキップ
Merck

Physicochemical characterization of Remsima.

mAbs (2014-12-18)
Soon Kwan Jung, Kyoung Hoon Lee, Jae Won Jeon, Joon Won Lee, Byoung Oh Kwon, Yeon Jung Kim, Jin Soo Bae, Dong-Il Kim, Soo Young Lee, Shin Jae Chang
要旨

Remsima (infliximab) was recently approved as the world's first biosimilar monoclonal antibody (mAb) in both the European Union and Korea. To achieve this, extensive physicochemical characterization of Remsima in relation to Remicade was conducted in order to demonstrate the highly similar properties between the two molecules. A multitude of state-of-the-art analyses revealed that Remsima has identical primary as well as indistinguishable higher order structures compared with the original product. Monomer and aggregate contents of Remsima were also found to be comparable with those of Remicade. In terms of charge isoforms, although Remsima was observed to contain slightly less basic variants than the original antibody, the difference was shown to be largely due to the presence of C-terminal lysine. On the other hand, this lysine was found to be rapidly clipped inside serum in vitro and in vivo, suggesting it has no effect on the biological potency or safety of the drug. Analysis of the glycan contents of the antibodies showed comparable glycan types and distributions. Recent results of clinical studies have further confirmed that the two antibody products are highly similar to each other. Based on this research as well as previous clinical and non-clinical comparability studies, Remsima can be considered as a highly similar molecule to Remicade in terms of physicochemical properties, efficacy, and safety for its final approval as a biosimilar product to Remicade.

材料
製品番号
ブランド
製品内容

Sigma-Aldrich
アセトニトリル, suitable for HPLC, gradient grade, ≥99.9%
Sigma-Aldrich
トリフルオロ酢酸, suitable for HPLC, ≥99.0%
Sigma-Aldrich
トリフルオロ酢酸, ReagentPlus®, 99%
Sigma-Aldrich
ギ酸, reagent grade, ≥95%
Sigma-Aldrich
グリシン, ReagentPlus®, ≥99% (HPLC)
Sigma-Aldrich
ギ酸, ACS reagent, ≥96%
Sigma-Aldrich
トリフルオロ酢酸, puriss. p.a., suitable for HPLC, ≥99.0% (GC)
Sigma-Aldrich
ギ酸, puriss. p.a., ACS reagent, reag. Ph. Eur., ≥98%
Sigma-Aldrich
アセトニトリル, ACS reagent, ≥99.5%
Sigma-Aldrich
グリシン, suitable for electrophoresis, ≥99%
Sigma-Aldrich
アセトニトリル, for HPLC, for UV, ≥99.9% (GC)
Sigma-Aldrich
ヨードアセトアミド, Single use vial of 56 mg
Sigma-Aldrich
アセトニトリル, suitable for HPLC, gradient grade, ≥99.9%
Sigma-Aldrich
ヨードアセトアミド, BioUltra
Sigma-Aldrich
DL-ジチオトレイトール 溶液, BioUltra, for molecular biology, ~1 M in H2O
Supelco
DL-ジチオトレイトール 溶液, 1 M in H2O
Sigma-Aldrich
グリシン, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
ヨードアセトアミド, ≥99% (NMR), crystalline
Sigma-Aldrich
ギ酸, puriss., meets analytical specifications of DAC, FCC, 98.0-100%
Sigma-Aldrich
トリフルオロ酢酸, ≥99%, for protein sequencing
Sigma-Aldrich
ギ酸, ACS reagent, ≥88%
Sigma-Aldrich
グリシン, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
アセトニトリル, suitable for HPLC-GC, ≥99.8% (GC)
Sigma-Aldrich
3,3′,5,5′-テトラメチルベンジジン, ≥99%
SAFC
グリシン
Sigma-Aldrich
アセトニトリル, biotech. grade, ≥99.93%
Sigma-Aldrich
3,3′,5,5′-テトラメチルベンジジン, ≥98% (TLC)
USP
グリシン, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
アセトニトリル, anhydrous, 99.8%
Sigma-Aldrich
ギ酸, ≥95%, FCC, FG