客户成功案例PIMS AAV Temp 徽标

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

要点

  • 公司的目标是从电子表格批量数据管理转向中央存储库
  • 采用结构化流程对多种企业批量数据管理产品进行了评估,该流程根据八项加权要求对候选产品进行评分
  • The Company selected IDBS PIMS 基于云的流程信息管理系统

业务需求

这是一家处于临床阶段的领先生物技术公司,正在开发视网膜、代谢和神经退行性疾病治疗领域的候选基因治疗产品。
公司利用多个外部合作伙伴,生产 AAV 病毒载体,作为其专有基因递送平台的一部分。公司的目标是摆脱电子表格批量数据管理,转而采用集中式存储库,加快基因递送平台的交付。 首席营销官 data and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

评估过程

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.

客户报价

制造科学副主任

  • We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives.
  • 重要的是要能随时获取数据,避免批量记录数据挖掘。
  • 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?

据报告,以下是最重要的价值主张:

  •  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.

成功的关键

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.

预期效益

  • 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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