Skyland PIMS Democratizes Batch Data Management for AAV Gene Therapies and Accelerates CMO Collaboration

Key points:

• The Company’s goal is to move away from spreadsheet batch data management to a centralized repository
• Multiple enterprise batch data management products were evaluated using a structured process that scored candidates on eight weighted requirements
• The Company selected Skyland PIMS cloud-based process information management system

Operational needs

A leading clinical-stage biotechnology company is developing gene therapy product candidates in the retinal, metabolic and neurodegenerative therapeutic areas.
Leveraging multiple external partners, it manufactures AAV viral vectors as part of its proprietary gene delivery platform. The Company’s goal is to move away from spreadsheet batch data management to a centralized repository, accelerate delivery of CMO data, and begin preparing for the rigorous data management requirements of process performance qualification and validation as it approaches commercialization.

Evaluation process

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 Skyland PIMS cloud-based process information management system.

Customer quotes

Associate Director of Manufacturing Sciences

• We needed an easy way to democratize process data for everyone to understand
  what was going on, from PD scientists to executives.
• Having data readily accessible and avoiding batch record data mining was important.
• The Skyland team and product is 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 fit our needs like PIMS did.

Why Skyland PIMS?

The following were reported as top value propositions:

• Centralized batch data management – Skyland 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 – Skyland 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 Skyland PIMS platform to evolve and meet its future business, regulatory and IT needs was very important to the Company.

Keys to success

The following were reported as important to selecting Skyland PIMS:

• Technical expertise – The Company’s team was impressed with the personal attention and access to Skyland’s development staff who provided detailed, well-thought-out responses to technical questions.
• Price point – Skyland PIMS’ licensing and all-inclusive cloud offering was very attractive compared to on-premise solutions with a higher total cost of ownership.

Expected benefits

• Batch data verification – The Company sees Skyland 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 Skyland PIMS offers.