絞り込み

16406

広告

原子炉建屋想定し高専生技術競う (デイリースポーツ)

東京電力福島第1原発の原子炉建屋を想定した会場で、高専生が自作ロボットの操作技術を競う「廃炉創造ロボコン」が16日、福島県楢葉町で開かれた。廃炉技術に興味を持っ...

  1. [企業] Andreessen Horo...
  2. 金井さん、17日宇宙へ (デイリースポー...
  3. 宇宙飛行士の金井さん あす打ち上げ 長期...
  4. [企業] Relay社 蛋白質の動きの理...

ニュース一覧

Evaluation of automated Wes system as an analytical and characterization tool to support monoclonal antibody drug product development.

著者 Wang J , Valdez A , Chen Y
J Pharm Biomed Anal.2016 Dec 21 ; ():.
この記事をPubMed上で見るPubMedで表示
この記事をGoogle翻訳上で見る Google翻訳で開く

スターを付ける スターを付ける     (10view , 0users)

Full Text Sources

Monitoring and evaluation of critical quality attributes (cQA) in monoclonal antibodies (mAb) are a regulatory requirement in pharmaceutical industry. High molecular weight (HMW) species are of critical importance due to the potential risk associated with immunogenicity. HMW species are typically monitored by size exclusion chromatography (SEC). Although low molecular weight (LMW) species are also detected by SEC, low-resolution separation of LMW limits its capability to monitor mAb fragmentation. Recently, we have developed new methods for LMW characterization and evaluation based on the Wes instrument from ProteinSimple. The capillary western blot is based upon size-based separation in a capillary system, and detection by specific immunoprobing, following the separation. The capability of this method for characterization of mAb fragments were demonstrated. The characterization was achieved by probing two antibodies targeted to specific regions (Fc region or Fab region) of IgG1 protein. The specificity of these two antibodies was evaluated against F (ab') 2 and Fc/2 fragments generated from Ides enzyme treated IgG1 protein. The results showed the selected antibodies provide high specificity to F (ab') 2 and Fc/2 fragments. Fractions collected from SEC were used to evaluate this method. The detected fragments from SEC fractions were identified based on their estimated molecular weight and antibody detection. The result proved the capability of the capillary western blot as a characterization method for IgG1 fragments. In addition, with the specific detection to IgG1 and IgG4, the power of the capillary western blot to specifically characterize and evaluate individual IgG fragmentations in an IgG1 and IgG4 mixture was also demonstrated. When heat stressed samples were used, results showed method capability as stability indicating in IgG1 and IgG4 mixture samples. The stressed mixture samples were also evaluated by the total protein assay in which protein samples were biotinylated after separation and were labeled with HRP linked streptavidin to provide chemiluminescence detection. The results indicated total protein assay can be a useful complementary method to capillary western blot immunoassay.
PMID: 28069351 [PubMed - as supplied by publisher]
印刷用ページを開く Endnote用テキストダウンロード