Cell & Gene Therapy: Easily and Confidently Centralize, Analyze and Share Product, Process and Patient Data Across Your Supply Chain

Developers of cell and gene therapies are increasingly looking at enhancing their clinical and commercial process data management approaches to address the challenges associated with more complex manufacturing processes, the explosion of data, short production timelines and global supply chains (CDMOs, CMOs, QC testing houses, logistics companies, etc.).

From collection of unique raw materials during apheresis through batch production to clinical endpoint data, Skyland PIMS® provides a CFR Part 11 compliant, centralized platform to establish common data structures, traceability and transparency while strengthening communication and collaboration across teams, sites and partners.

PIMS™ breaks down data silos and ensures data transparency and traceability among internal teams as well as external partners throughout the development and production supply chain.

We have data everywhere in different formats. PIMS enables us to bring this data into one validatable space.

MSAT Manager, Global Gene Therapy Company

Ultimately the big value is the data repository, streamlined batch review and verification, and knowing what data can be trusted.

Head Process Engineer, Early Stage CAR T Immunotherapy Company

We needed a solution that allows for greater levels of data integrity and scale in terms of being able to generate and analyze even more batches as we go forward. We use Skyland PIMS to form the process knowledge base for the CMC section for our BLA.

Head of Technical Operations, Restorative Cell Therapy Company

BPI Article: Cell and Gene Therapy Data Management: Solutions to Address Complex Challenges

Featuring Steve Goodman (bluebird bio Head of Drug Product Manufacturing) and Robert Di Scipio (Skyland CEO)

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Customer Spotlights.
Explore how Skyland PIMS addresses business, operations and regulatory requirements.

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PIMS in action using a CAR T process (5 min video)

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Learn How Robust Process, Product and Patient Data Management Accelerates CGT Development and Manufacturing Success

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Persistent Knowledge Base

Serving as a persistent product and process data library, Skyland PIMS ensures process knowledge is maintained across the supply chain and throughout the product life cycle. PIMS tracks changes to process and product specifications and target control limits with a full audit trail of authorship, timestamp and rationale. PIMS also supports document attachments, comments, URLs and flowcharts for additional context

Enhanced Data Integrity

With no custom coding required, PIMS’ automatic derived values and digital query capabilities together with its intuitive data entry and approval workflows provide higher levels of data integrity compared to Excel and bespoke solutions.

Accelerated, Actionable Insights

Skyland PIMS makes efficient use of scarce resources with its unique Data Cascadefunctionality providing data contextualization throughout required data sets enabling rapid automatic data analytics and charting for KPIs, continuous process verification (CPV), preparation of APRs, process optimization, process validation, and batch release.

Skyland PIMS was purpose-built to meet your technical requirements:

  • Cloud-Based
  • Controlled & Secure Data Sharing
  • 21 CFR Part 11 Compliant
  • Validatable
  • Persistent Knowledge Base
  • User Friendly
  • Easily Configurable
  • Minimal IT Involvement
  • Digital Data Source Connectivity
  • Rapid Deployment
  • Scalable to Fit All IT Landscapes
  • Low Total Cost of Ownership
  • Intuitive Workflows
  • No Coding