Endocyte is a biopharmaceutical company seeking to maximize the potential of small molecule drug conjugates (SMDCs) with companion imaging agents. The goal of the Endocyte process is to identify patients who can benefit from treatment, enabling physicians and patients to make accurate, timely treatment decisions.
For Endocyte, regulations determined their need to monitor temperature control equipment and laboratories to ensure all critical assets were properly maintained; and with a monitoring system that was FDA 21 CFR Part 11 compliant.
The company has a large network of 53 monitoring points including laboratories, refrigerators, freezers and environmental chambers. These include an array of material from tissues for clinical trials; reagents and cells for drug discovery; and buffers and chemicals for analytical development. The facility also includes quality GMP rooms for drug product storage, drug substances and intermediates used in manufacturing of lyophilized injectable products. Another core part of their facilities include accelerated stability chambers, used in all phases of development. These environmental rooms measure how quickly products degrade by pushing the levels of temperature and humidity. This determines the product stability profile for regulatory product filing.
Endocyte needed an environmental monitoring solution for their facilities that would:
Give complete insight and visibility into all labs and equipment to ensure they were functioning properly around the clock
A secure system that could potentially continue running in case of power failure
Easy to use system that would send alarm notifications conveniently such as email or text so corrective action could be taken quickly
Pass all regulatory requirements for data handling and system ownership including FDA 21 CFR Part 11, GMP, GLP and GAMP 5
The Solution: Central, Continuous Monitoring
Endocyte chose ELPRO’s Central Monitoring System elproSUITE to meet their needs for a compliant and reliable environmental monitoring solution. This includes the ECOLOG-NET LP4, LA8 (wired) and LR8 (wireless). The ECOLOG-NET LP4 is a 4 channel datalogger designed for logging and monitoring temperatures over a period up to 90 days, still collecting data without power due to integrated backup battery. Standardized Pt100 measuring technology allows the unit to be used for a multitude of various applications that fit well in Endocyte’s facilities.
For certain parts of Endocyte’s facilities, specifically GMP areas, the most highly secure and reliable system was necessary. Therefore ECOLOG-NET LA8 as a wired system was implemented using a hardwired LAN connection. A true wired system physically has a wire between the sensor and logger, therefore there is no concern of loss of data transmission. The LA8 datalogger can read any 4-20 mA inputs for logging differential pressure, CO2 or particle concentrations.
Regulations seem to constantly change from Endocyte’s perspective; but FDA 21 CFR Part 11 on drug storage and manufacture of clinical drug products was definitely the most predominant regulation to follow. For a biopharma company involved in clinical trials, this regulation was even more specific for Phase III Trials and what the requirements were for a redundant monitoring system, stating specifically that GMP store rooms should only be accessed by certain approved personnel and such access could be proven and documented. For example, if a GMP room goes out of temperature range, how does Endocyte prove who made any changes to the CMS system alarm limits or other system settings? Therein lies the importance of a reliable audit trail using an effective CMS system, including electronic signatures, password protection, and unique usernames. Data security is paramount to ensure critical asset integrity, and regulatory compliance.
In addition to having compliant software and data handling, Endocyte wanted intuitive software that was easy to use by all stakeholders and could centrally monitor their network of labs, refrigerators, freezers and GMP facilities. ECOLOG-NET stores the data on a central network, allowing the Facility Manager to see all measurement point values, alarms and deviations remotely, giving complete control and visibility into how the facility is performing at all times. In case of deviations and alarms, the Facility Manager is conveniently emailed or text message informed regarding the alarm status to ensure prompt action can be taken.
Redundancy and Security
The very basis of a redundant system is to ensure continued operation in the case of power, internet or hardware failure. If one component is removed, the rest of the system still operates. It also means if there is an alarm, the alarm notification is redundant in several locations, i.e. locally, telephone email, computer, etc. so that it’s certain to be received by the system owner. Another paramount security factor with the elproSUITE is that Endocyte owns their data. In a GMP regulated environment this is necessary to ensure accessibility at all times, even in the case of a power failure. Alternative CMS systems hosted off-site, or cloud services, can have ‘down time’; limiting customers access to their data and often subject to recurring fees. Not to mention, what if the off-site service provider closes, where does the data go then?
Read more in the article, How a CMS works and questions to consider, about how redundancy and system design impact your research facilities.
Validation and Qualification
In a GMP or regulatory driven environment, not only are data handling processes under potential scrutiny by authorities, the actual CMS system itself must meet certain criteria to prove it operates as the manuals say it does. Endocyte worked with an external consultant like many biopharma companies to ensure the system was completely validated. Rather than each biopharma company validating the system themselves, ELPRO has already fully GMP validated our CMS system with complete documentation, thus saving customers a huge amount of time to go through the entire qualification themselves. ELPRO’s IQ and OQ full documentation has been used by a long list of customers and accepted by a number of regulatory agencies.
Right now, Endocyte is creating protocols for conducting regular reporting of their facilities’ performance. This is a key reason they decided to use the ELPRO Central Monitoring System. Facility Managers can create schedules for the CMS system to automatically generate a report for their needs, to receive notifications of alarms and events periodically (weekly, monthly, yearly) and / or report per sensor (alarms and events).
«Our next step with the CMS system is to provide regular reports to Endocyte management how well the facilities are performing and proactively identify any problem equipment or handling process errors.»Alyssa Mahlke, Facility Manager, Endocyte
Read more about establishing GLP compliant monitoring processes for research facilities in the white paper Transitioning to an Enterprise CMS (Environmental Monitoring System) in a Regulated Environment