Top 5 global CDMO relies on cloud-based IDBS PIMS to collaborate with sponsors, ensure regulatory compliance and secure product quality
The CDMO improved its manufacturing data collection and information visibility for real-time decision-making.
- This CDMO was relying on email to communicate project data updates to customers
- It sought out a single system that could handle multiple project sites and standardize processes while still being flexible
- It has seen improved technical capability in batch data monitoring and client information sharing
A top five global CDMO implemented a process information management system (PIMS) from IDBS for improved manufacturing data collection and information visibility for real-time decision-making related to more than 1,200 products that the company manufactures.
As a strategic CDMO and clinical services partner offering an end-to-end supply chain solution for BioPharma-integrated drug development, it is imperative that this top five global CDMO accelerates process understanding and ensures product quality – while maintaining regulatory compliance, says their Director of Biomanufacturing Global Network Operations.
However, like many of its CDMO counterparts, this top five global CDMO was relying on email to communicate project data updates to customers. This data was being collected using disparate, disconnected spreadsheets that were typically formatted differently depending on the process engineer. Finally, there was no secondary check on the data, which opened the door for inconsistencies in data and potential errors.
According to one of their project managers, the Company realized that these obstacles were having a negative impact on effective and fast decision-making to efficiently and proactively monitor processes, prevent batch failure and assist and streamline continued process verification (CPV) reporting during batch manufacturing.
The top five global CDMO made the decision to seek out a single system that could handle multiple project sites and standardize processes while still being flexible enough to accommodate different processes, from process development to clinical through to commercial manufacturing. “It was also important that we found software that required limited IT assistance and did not require validation for each new process and product that we were being asked to support,” says their Director of Biomanufacturing Global Network Operations.
Also critical, he says, was finding a solution that could leverage clinical data sets and process knowledge as the basis for commercial manufacturing processes, manage data to conform to evolving regulations, mitigate risk, enable and promote data sharing with drug sponsors and comply with 21 CFR Part 11.
The top five global CDMO reviewed existing products on the market, most of which required significant IT support, a long and resource-intensive set-up period and regular validation for each process and product.
The top five global CDMO ultimately chose cloud-based IDBS PIMS for its ease of use, data visibility both internally and externally, and its ability to validate manufacturing processes. Since implementing IDBS PIMS, the Project Manager says the top five global CDMO has seen improved technical capability in batch data monitoring, client information sharing and much more efficient CPV reporting without using disparate data systems.
The top five global CDMO uses PIMS for daily monitoring, which has proven beneficial in identifying potential manufacturing issues quickly and expediting remediation to save what would have ended in full or partial lost batches. “We currently have 50% of the team using PIMS to investigate deviations with great success,” says the Project Manager. “We expect to increase its use for this purpose and go to PIMS first when doing a data review and to receive clearer direction on what to investigate.”
Additional benefits realized using IDBS PIMS include:
- Enhanced data reporting of all in-process control (IPC) parameters, microbial control, daily sample analysis and daily process monitoring;
- Improved visibility of product, process and batch data management to create a secure audit trail; and
- Real-time data sharing; clients can view their product as the batch is progressing remotely.
With these efficiency and quality improvements in place, the top five CDMO expects cost savings equivalent to nearly 13,000 hours per year across all teams using PIMS (Fig. 1).
Figure 1: Time savings expected from PIMS (Source: IDBS 2023 internal data).
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