JSR株式会社
JSRグループのライフサイエンス事業は「JSR Life Sciences」として、抗体医薬製造用材料（バイオプロセス用材料）、診断・研究試薬材料、抗体医薬開発・製造受託サービスを提供しています。
会社カテゴリー：原薬・添加剤・中間体、製造受託機関(CMO)、分析、試験受託サービス、医薬品製造関連資材、研究関連資材
主サービス提供地域：日本、アメリカ合衆国、中華人民共和国、大韓民国、台湾、ヨーロッパ(イギリス以外)、イギリス、インド
製品・サービス詳細
CLONALITY ASSURANCE クロナリティの評価
サービスカテゴリー：開発、分析、製造
Establishing monoclonality of research cell banks (RCB) and manufacturing cell banks (MCB) is critical for successful and cost-effective biologic manufacturing campaigns and regulatory filings.
研究用細胞株（RCB）と製造用細胞株（MCB）のクロナリティ評価サービス。規制当局との円滑な交渉、また製造に伴うリスクの低減をサポートします。
Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality...
Utilizing whole genome sequencing (WGS) and proprietary bioinformatics tools, Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality using integration sites as markers and provide transgene sequence, copy number and integrity. Additionally, Selexis has established a method for establishing clonality, based on a FISH-DNA platform, by detecting the specific location of the integrated recombinant transgene at the chromosomal level. In the case that two or more FISH patterns are found in the MCB, either the cell line is nonclonal in origin or chromosomal rearrangement has occurred during propagation. This method allows for analysis of single cells to assess the homogeneity within the parental population.
Three Possible Solutions for Accurate Determination of Clonality of Cell Lines:
