お客様の成功事例PIMS AAV Temp ロゴ

IDBS PIMS democratizes batch data management for AAV Gene Therapies and accelerates CMO collaboration

重要なポイント

  • 当社の目標は、スプレッドシートのバッチ・データ管理から一元化されたレポジトリに移行することである。
  • 複数の企業向けバッチデータ管理製品が、以下の8つの要件に重点を置いて候補製品を採点する構造化プロセスを用いて評価された。
  • The Company selected IDBS PIMS クラウド型プロセス情報管理システム

運営上のニーズ

臨床段階の大手バイオテクノロジー企業で、網膜、代謝、神経変性治療領域における遺伝子治療製品候補を開発している。
複数の外部パートナーを活用し、独自の遺伝子導入プラットフォームの一部としてAAVウイルスベクターを製造している。当社の目標は、スプレッドシートのバッチ・データ管理から一元化されたレポジトリに移行し、遺伝子導入のデリバリーを加速することである。 CMO data and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

評価プロセス

The Company’s manufacturing team is experienced with enterprise batch data management and quality assurance, which led them to seek a solution that is easy to implement, offered intuitive data entry and democratizes data so that all stakeholders have easy access. The Company formed a selection task force led by its Senior Manager of Manufacturing Sciences. Multiple enterprise batch data management products were evaluated using a structured process that scored candidates on eight weighted requirements. Based on this rigorous scoring methodology and following final approval from its executive team, the Company selected IDBS PIMS cloud-based process information management system.

お客様の声

製造科学部門アソシエイト・ディレクター

  • We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives.
  • データにすぐにアクセスでき、一括記録のデータマイニングを避けることが重要だった。
  • The product team and product are what sold us.
  • We were impressed with the overall ease of configuration and navigation as well as flexibility for use across many partners and products.
  • There just isn’t another product out there that fits our needs like PIMS does.

Why IDBS PIMS?

トップ・バリュー・プロポジションとして以下のものが報告された:

  •  Centralized batch data management – IDBS PIMS enables efficient consolidation of batch data records into a validatable single source of truth with out-of-the-box integrated analytics for CPV APR and process optimization.
  • CMO data delivery – IDBS PIMS streamlines CMO batch data delivery by providing manufacturing partners with direct secure access to intuitive batch data entry and collaboration workflow features.
  • Product roadmap – Flexibility of the IDBS PIMS platform to evolve and meet its future business, regulatory and IT needs was very important to the Company.

成功の鍵

The following were reported as important to selecting IDBS PIMS:

  • Technical expertise – The Company’s team was impressed with the personal attention and access to the product development staff who provided detailed, well-thought-out responses to technical questions.
  • Price point – IDBS PIMS’ licensing and all-inclusive cloud offering was very attractive compared to on-premise solutions with a higher total cost of ownership.

期待される効果

  • Batch data verification – The Company sees IDBS PIMS as a complete batch data management and QC solution that will be integral to its large-scale commercialization efforts.
  • 21 CFR Part 11 – As its pipeline of gene therapies nears commercialization, the Company will be able to quickly standup a validated system by avoiding the time and cost of manually mining batch data while benefiting from the 21 CFR Part 11 compliance that IDBS PIMS offers.
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