Remotely monitored environments hold the medicines of the future

Published 2022-08-10

ClinStorage has found a growing niche in the pharmaceutical industry. In meticulously controlled warehouses, they store the medicines of the future. The company uses the validated testo Saveris 1 computerized remote monitoring system to ensure that any temperature changes in refrigerators and freezers can be detected and acted upon quickly.

– Having full control of temperatures is essential for us, says Sven Jacobsson of ClinStorage. Sven runs ClinStorage together with Ola Camber. Sven has a PhD in analytical chemistry and Ola in pharmacy (drug development). Both previously worked in senior positions at major pharmaceutical companies such as Pharmacia and AstraZeneca.

– We discovered that solving how to handle and store investigational medicinal products and different active substances correctly and reliably was not a trivial task. It is often difficult for many smaller biotech companies to solve this,” says Sven.

High interest in pharmaceutical storage
In 2008, Sven Jacobsson and Ola Camber started ClinStorage. It quickly became apparent that there was great interest among mainly smaller pharmaceutical companies to get help with storage that meets the authorities’ high standards. ClinStorage has grown steadily and currently employs six people in a 300 square meter, specially designed warehouse in Solna, just north of Stockholm. The customers are drug development companies in Sweden and the other Nordic countries.

– In addition to storage, we also coordinate and manage transportation in cooperation with established freight forwarders. We are what you would call a one stop shop,” says Sven.

The choice fell on the testo Saveris 1
In order to get even better control of all temperature levels, Sven Jacobsson and Ola Camber decided a few years ago to invest in a digitalized, validatable monitoring system for pharmaceutical storage. Together with a consultant, they compared various systems on the market before finally choosing testo Saveris 1, which today monitors the temperatures in some 30 rooms, refrigerators, freezers, tanks and thermoses via a large number of loggers. The system is also connected to the diesel power plant that ClinStorage has as a backup to ensure safe 24/7 operations.

– Everything is working well and we are very satisfied. What was crucial was that we have been able to validate the system and have an annual calibration of all measuring equipment. This provides us with reliable data and also good documentation to show when we are inspected by authorities or customers who want to see details of how the temperature monitoring is structured and what procedures are in place for different scenarios.

Validation ensures functionality
Shortly after Nordtec has installed and commissioned testo Saveris 1 for ClinStorage, a validation of the entire monitoring system was carried out. This is to ensure that the system meets the requirements specification. It was an extensive and thorough review, to say the least. Every single detail was tested and evaluated. Nordtec’s representative checked that measurement data cannot be manipulated, that all interactions in the system can be traced, that alarm levels on all sensors work, that every employee at ClinStorage has the right authorization, that all alarms work as they should, that all measurement data is collected and stored securely (with backups) – just to name a few examples.

What exactly are you storing?
– Investigational medicinal products. That is, before a medicine is approved by the authorities to be prescribed by doctors and sold commercially, it goes through a series of clinical tests to demonstrate efficacy and examine the risk of side effects. While this is being done, the medicine should be stored in the same conditions as the finished medicine, so that it is not affected and retains its properties,” says Sven:

– A finished medicine, such as a vaccine, can consist of a large number of components such as excipients and carrier systems. Each such component, or pharmaceutical material as it is often called, requires storage at a certain specified temperature.

What temperatures are involved?
– We have everything from ultra-low temperatures like minus 196 (!) degrees (in the gas phase above liquid nitrogen) to storing pharmaceutical materials at plus 30 degrees. To cope with this wide range of temperatures, we need highly accurate and calibrated measuring equipment to read the correct temperatures.

How long do you store the medicines?
– These range from temporary storage of three to six months to storage for up to ten years. This means we need easy access to digital temperature data over a long period of time. Because if there is a problem in the clinical trial, you want to be able to go back and look at what the temperature curve looked like maybe five years ago when you started to store the drug.

Do you see any trends in the pharmaceutical industry?
– There is an increasing focus on advanced therapy medicinal products, which is the umbrella term for cell, gene and tissue therapies. In other words, biology is more like medicine, for example by adding a cell that can attack a cancerous tumor or a genetic code that allows the body to develop a defense. An obvious, current and clear trend is the Covid-19 vaccines from Pfizer-BioNtech and Moderna, which add the macromolecule mRNA so that the body can develop an antibody repository against generated spike proteins. These groups of products also have in common that they require significantly lower temperatures for storage and distribution compared to traditional medicines. We at ClinStorage are at the forefront of providing such storage and distribution solutions.

What are you aiming for next?
– We have developed a new service where we label and pack medicines to be sent to clinical trials. We have recently been inspected by the Swedish Medical Products Agency and hope to be certified for this type of handling in the near future. In terms of space, we have the capacity to grow for the next few years, but if the growth continues unabated, we will probably need a more large-scale expansion. Whether this can be done in our existing premises or in new facilities remains to be seen.