CO.DON was founded in 1993 as a biotech company and has developed a procedure for the production of personalized cell therapies for cartilage defects. In state-of-the-art and so far globally unique facilities, cartilage cells from the patients are cultivated based on a taken sample and subsequently implanted back into them. The bodies of the patients accept the cultivated cartilage as their own, effectively healing joint defects.
In the production process of CO.DON, various isolators are used in a cleanroom environment to isolate the cartilage cells from the patient’s sample. The cartilage cells are then cultivated in incubators for approximately 30-60 days, with the addition of a serum. The adherence to limit values within the facility is a mandatory requirement for ensuring guaranteed quality, high effectiveness, and compatibility of the produced cartilage cells.
As a company in the pharmaceutical industry, CO.DON is subject to strict guidelines that necessitate, among other things, seamless monitoring of production processes and adherence to documentation requirements. Compliance with these Good Manufacturing Practices (GMP) guidelines is regularly audited by official authorities.
From the beginning, CO.DON has relied on digital tools for monitoring production parameters and environmental variables. However, the implemented solution provided by the equipment manufacturer has proven to be inadequate both in practical use and in terms of meeting the requirements of the certification authority.
The objectice of CO.DON
In November 2022, Mathias Striese, Head of Engineering at CO.DON, became aware of ENLYZE as a solution to achieve seamless recording, documentation, and monitoring of all critical plant parameters.
As a prerequisite, it was clear that GMP compliance must be ensured. In addition to data validity verification, long-term data storage for a period of 30 years is also included, utilizing redundant data storage systems. At the same time, the software should be user-friendly and customizable to meet the individual needs of the users.
In particular, the qualified person should receive visual support during batch release to easily detect process anomalies and parameter deviations throughout the production of a batch. This ensures traceability of process deviations based on the batch number. Therefore, the ability to link with the data from the quality management software by MasterControl, which is currently under development, was crucial.
Due to the dynamic corporate culture and upcoming audits, a timely implementation without significant internal resource allocation was crucial for CO.DON.
In summary, CO.DON was focused on the following aspects in their search for a new process monitoring and traceability solution:
Speed of implementation
High service level and low internal resource commitment
Reliable, redundant data recording including validation of data correctness to comply with GMP guidelines
User-friendly interface and adaptability to user needs
Automated monitoring of threshold values
Future-proofing of the solution by enriching the process parameters with further context information from the MasterControl system
At the end of February 2023, ENLYZE visited CO.DON’s production site in Leipzig for the first time and connected all 24 controllers of the entire production plant on the same day. The integration effort on the part of CO.DON was simply to configure the firewall. The rest was done by ENLYZE within 5h without interrupting the operational process.
Just one week later, ENLYZE had identified the necessary data from the controllers and, where needed, corrected it by scaling accordingly. Nothing stood in the way of validating the recorded values according to GMP guidelines. The first versions of a Grafana dashboard have already been used for this validation.
All collected data is stored by ENLYZE in two different cloud systems with two different providers by default. Long-term, redundant data storage was thus also ensured.
The extension of the data recording with additional plant parameters could be done independently by Mathias Striese using the “ENLYZE Variable Selection Flows” and the “Variable Contextualization”. He was eventually able to further modify the initial Grafana dashboards to fit CO.DON’s needs.
In particular, the input of colleagues from production and quality management was crucial here. A clear plant monitoring was crucial for production. Deviation of individual parameters and impending exceedance of threshold values should be detected early on, enabling timely corrective actions to be taken in the production process.
The quality assurance department required a visual representation of the plant parameters over specific production batch timeframes. This visualization serves both for documentation purposes and for validating process conformity, ensuring that the plant parameters remained within the defined limits. The ease of use now saves time for the qualified person, and the visual representation provides an additional layer of safety to prevent errors.
Down the road, CO.DON will also feed process deviation alerts into dedicated MS Teams channels. These notifications should further improve the response time. Furthermore, there are already discussions on how to adapt the rules underlying the alarms to provide early indication of impending instabilities.
Moreover, in addition to redundant cloud storage, local data storage is also important as further security for seamless data recording to meet GMP guidelines. The technical implementation is to be realized with another edge device from ENLYZE as well as local databases that receive the data via MQTT.