About CO.DON

CO.DON was founded in 1993 as a biotech company and has developed a process for manufacturing personalized cell therapies for cartilage defects. In state-of-the-art, and currently unique facilities worldwide, cartilage cells from patients are cultured from a taken sample and subsequently implanted. The patients' bodies accept the cultivated cartilage as their own, effectively healing joint defects.

In the production of CO.DON, various isolators are used to isolate the cartilage cells from the patients' samples under a protective atmosphere. With the addition of a serum, the cartilage cells are then cultivated in incubators for about 30-60 days. Compliance with limit values within the facility is a mandatory requirement for guaranteed quality, high efficacy, and compatibility of the produced cartilage cells.

Situation

As a company in the pharmaceutical industry, CO.DON is bound by strict regulations that, among other things, require continuous monitoring of production and documentation obligations. Compliance with these GMP guidelines (Good Manufacturing Practices) is regularly checked by official bodies.

From the very beginning, CO.DON relied on digital tools for monitoring production parameters and environmental variables; however, the implemented solution from the equipment manufacturer proved to be inadequate in everyday use and from the perspective of the certification body.

Objectives of CO.DON

In November 2022, Mathias Striese - Head of Engineering at CO.DON - became aware of ENLYZE to implement a solution for comprehensive recording, documentation, and monitoring of all critical plant parameters.

It was clear that GMP compliance must be ensured. In addition to the verifiability of data validity, long-term data storage for over 30 years in redundant data storage must also be included. At the same time, the software should be easy to use and adaptable to the individual needs of users.

In particular, the qualified person should receive visual support within the framework of batch release to easily recognize process anomalies and deviations of parameters over the course of production of a batch. Thus, traceability of process deviations based on the batch number should be ensured. Therefore, the connectability with the data from the quality management software from MasterControl, which is still under development, was also crucial.

Due to the dynamic corporate culture and upcoming audits, timely implementation without significant internal resource expenditure was also crucial for CO.DON.

In summary, CO.DON was looking for a new process monitoring and traceability solution that focused on the following points:

Speed of implementation

• High service level and low internal resource commitment

• Reliable, redundant data recording along with validation of data accuracy to comply with GMP guidelines

• Ease of use and adaptability to user needs

• Automated monitoring of limit values

• Future viability of the solution through enrichment of process parameters with additional contextual information from the MasterControl system

The Solution

At the end of February 2023, ENLYZE visited the production site of CO.DON in Leipzig for the first time and connected all 24 controls of the entire production plant on the same day. The integration effort on the part of CO.DON was limited to configuring the firewall. ENLYZE took care of the rest within 5 hours without halting operations.

"The use of Grafana was a real game changer for us. Especially with the ENLYZE infrastructure in the background, we were able to visualize our data at high speed within an intuitive environment and set alarms as we needed. The possibilities here with Grafana are nearly limitless. The agility also impressed my team: with new insights, changes could be implemented with just a few clicks."

- Mathias Striese, Head of Engineering CO.DON

Just a week later, ENLYZE had identified the necessary data from the controls and, where necessary, corrected them through appropriate scaling. There were no longer any obstacles to validating the recorded values according to GMP guidelines. Initial versions of a Grafana dashboard were already employed for this validation.

All collected data is automatically stored by ENLYZE in two different cloud systems with two different providers. Thus, long-term, redundant data storage was also ensured.

The expansion of data recording to include additional plant parameters could be carried out by Mathias Striese independently using the “ENLYZE Variable Selection Flows” and “Variable Contextualization.” He was then able to further modify the initial Grafana dashboards and adapt them to the needs of CO.DON.

In particular, the input from colleagues in production and quality management was crucial here. For production, a clear monitoring of plant operations was essential. Deviations from individual parameters and impending limit value breaches should be detected early so that corrective action can be taken in production.

Quality assurance required a visual presentation of the plant parameters over the periods of specific production batches. This presentation serves both documentation and validation of process conformity, meaning that the plant parameters behaved within the defined limit values. The ease of use now saves particularly the qualified person time, and the visual presentation provides an additional safety layer for error prevention.

"Since establishing our site, we have never experienced such a fast and smooth implementation of a digital solution. ENLYZE came to us and was able to connect directly with our controls without any problems. Colin, Clemens, and Henning immediately understood what we needed and were able to present a functioning solution within a few days. I could then make further adjustments myself with just a few clicks. We had already resigned ourselves to a lengthy process. But the speed and competence of ENLYZE showed us that it can be done differently."

- Mathias Striese