고객 성공 사례PIMS AAV 임시 로고

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

요점

  • 회사의 목표는 스프레드시트 일괄 데이터 관리에서 중앙 집중식 리포지토리로 전환하는 것입니다.
  • 여러 엔터프라이즈 배치 데이터 관리 제품을 8가지 가중치 요구 사항에 따라 점수를 매기는 구조화된 프로세스를 사용하여 평가했습니다.
  • The Company selected IDBS PIMS 클라우드 기반 프로세스 정보 관리 시스템

운영 요구 사항

한 선도적인 임상 단계의 생명공학 회사는 망막, 대사 및 신경 퇴행성 치료 분야에서 유전자 치료 제품 후보를 개발하고 있습니다.
여러 외부 파트너를 활용하여 독점적인 유전자 전달 플랫폼의 일부로 AAV 바이러스 벡터를 제조합니다. 이 회사의 목표는 스프레드시트 배치 데이터 관리에서 중앙 집중식 리포지토리로 전환하고, 다음을 신속하게 제공하는 것입니다. CMO data and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

평가 프로세스

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.

고객 견적

제조 과학 부책임자

  • We needed an easy way to democratize process data for everyone to understand what was going on, from PD scientists to executives.
  • 데이터에 쉽게 액세스할 수 있도록 하고 일괄 기록 데이터 마이닝을 피하는 것이 중요했습니다.
  • 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?

다음은 최고의 가치 제안으로 보고된 내용입니다:

  •  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.

성공의 열쇠

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.

기대되는 이점

  • 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.
사례 연구 다운로드

고객 성공

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