Casos de éxito de clientesPIMS AAV Temp Logotipo

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

Puntos clave:

  • El objetivo de la empresa es pasar de la gestión de datos por lotes en hojas de cálculo a un repositorio centralizado
  • Se evaluaron varios productos empresariales de gestión de datos por lotes mediante un proceso estructurado que puntuaba a los candidatos en función de ocho requisitos ponderados
  • The Company selected IDBS PIMS sistema de gestión de la información de procesos basado en la nube

Necesidades operativas

Una empresa biotecnológica líder en fase clínica está desarrollando candidatos a productos de terapia génica en las áreas terapéuticas de retina, metabolismo y neurodegeneración.
Con la ayuda de múltiples socios externos, fabrica vectores virales AAV como parte de su plataforma patentada de administración de genes. El objetivo de la empresa es pasar de la gestión de datos por lotes en hojas de cálculo a un repositorio centralizado, acelerar la entrega de OCM data and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

Proceso de evaluación

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.

Presupuestos de clientes

Director Asociado de Ciencias de la Fabricación

  • We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives.
  • Era importante disponer de datos fácilmente accesibles y evitar la extracción de datos de registros por lotes.
  • 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?

Las principales propuestas de valor son las siguientes:

  •  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.

Claves del éxito

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.

Beneficios esperados

  • 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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