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

Points clés :

  • L'objectif de l'entreprise est d'abandonner la gestion des données par lots à l'aide d'un tableur au profit d'un référentiel centralisé
  • Plusieurs produits de gestion des données de lots d'entreprise ont été évalués à l'aide d'un processus structuré qui a permis de noter les candidats en fonction de huit critères pondérés
  • The Company selected IDBS PIMS système de gestion des informations sur les processus basé sur l'informatique en nuage

Besoins opérationnels

Une société de biotechnologie de premier plan au stade clinique développe des produits candidats de thérapie génique dans les domaines thérapeutiques de la rétine, du métabolisme et de la neurodégénérescence.
En s'appuyant sur de multiples partenaires externes, elle fabrique des vecteurs viraux AAV dans le cadre de sa plateforme propriétaire d'administration de gènes. L'objectif de l'entreprise est d'abandonner la gestion des données par lots à l'aide de tableurs au profit d'un référentiel centralisé, d'accélérer la livraison des vaccins et d'améliorer la qualité des produits. OCM data and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

Processus d'évaluation

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.

Devis clients

Directeur associé des sciences de la fabrication

  • We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives.
  • Il était important d'avoir des données facilement accessibles et d'éviter l'extraction de données par lots.
  • 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?

Les propositions suivantes ont été signalées comme étant les plus intéressantes :

  •  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.

Les clés de la réussite

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.

Bénéfices attendus

  • 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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