Leading Biotech Company Paves Its Way to Success with Skyland PIMS

HOW A LEADING BIOTECH COMPANY CREATED A SINGLE SOURCE OF DATA TRUTH FOR ITS DIVERSE MANUFACTURING NETWORK WITH COMPLIANT, SCALABLE PROCESS DATA MANAGEMENT TECHNOLOGY

Summary:

Hear from Mark Isaacs, VP of Sales, and Teodor Leahu, Director of European Operations, how Skyland PIMS® cloud-based and compliant data management system helps a leading biotech company efficiently manage critical process data across its expanding manufacturing network. Mark and Teodor discuss the Company’s needs, how PIMS™ addresses these needs, and the pivotal role PIMS is playing in the Company’s digital transformation.

The Biotech’s product was in Phase III trials when it began searching for a data management solution to support its current small batch US captive production and near-future large batch EU CMO production.

One of the key objectives for adopting new technology was to establish a single source of truth across its manufacturing supply chain to support tech transfer efforts and the ongoing process monitoring program.

The challenge

Given the product’s Phase III status, it was vital to adopt compliant, validatable technology that supports the Company’s Continued Process Verification (CPV) strategy.

The Company wanted a system that streamlined tech transfer while also providing timely visibility of its CMO’s data. They sought to establish an end-to-end view of the manufacturing process’ performance and required analytical capabilities to efficiently conduct batch-to-batch and site-to-site comparisons.

The IT infrastructure at each facility was at varying levels of maturity. One predominately used paper and Excel to manage data, while the other included standard data management systems such as LIMS. The new technology needed to be flexible enough to handle data from both environments – hand-entered, spreadsheet upload, and system integration capabilities. The system also needed to scale as the facilities’ infrastructures evolved and provide data integrity insurance at every step.

Given the complexity of the requirements, the Company conducted a proof-of-concept (POC) with their CMO to ensure PIMS met their needs.

“It was unusual and encouraging that the Sponsor and the CMO collaborated on the proof-of-concept,” stated Mark. “They worked together to understand the technology and experienced first-hand the expertise of our services team to rapidly build the process definition’s unit operations with terms that both the Sponsor and CMO required for operational success.”

The solution

The Company confirmed PIMS maintained the level of data integrity required for their unique use case, serving as the single source of data truth within their geographically dispersed and technically different manufacturing network.

With both captive and CMO data being easily configured and analyzed in one place, the Company will meet its need for supply chain visibility and site-to-site comparisons in the same repository rather than constantly checking between paper and Excel and different versions of the truth.

The built-in analytics replaces the time-consuming and costly transfer and validating of data to a desktop system. Using PIMS’ comprehensive validation kit, the Company will save up to 80% of the time traditionally spent on validation efforts and move into a validated state in weeks.

The journey from discovery to PIMS implementation was completed in a matter of months, and the Customer was thrilled by the efficiency and quality of the IDBS team.

The future

The Company expects to benefit from PIMS’ ability to provide deeper process understanding. Serving as a persistent, dynamic knowledge base across the product lifecycle, PIMS bridges the data gap between process development and manufacturing, allowing for a continual feedback loop of information to support continuous process improvement.

The Biotech also sees great value in the ease at which PIMS enables knowledge to be shared across internal and external teams, sites, and partners. The Company plans to expedite time to market by applying past learnings to the products entering their clinical pipelines, including different versions of the same drug or the same unit operations to other products.

They also acknowledge that information flow is very powerful, but the value of one-directional information flow – from process development to manufacturing – is limited. After tech transfer, thousands of manufacturing data points are not used or not even recorded. If recorded, they go into data cemeteries where they’re not leveraged. PIMS’ ability to make data bidirectional is extraordinary and novel for the industry.

About the customer

This leading biotech company excels at translating scientific research into clinically actionable test results based on a deep understanding of the human genome and the biology behind the genetic disease. Its unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate, and pharmaceutical partners, means it is first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions.