The development of a new drug is one of the longest and most expensive processes in modern science. It takes an average of 10 to 15 years from the initial idea to approval, and the costs can reach several billion euros. In practically every phase of this process, cryopreservation plays a crucial, albeit often invisible, role.
From the storage of biological reference samples to the preservation of cell lines for drug tests and the provision of clinical test samples - without reliable cryotechnology, the entire drug development process would come to a standstill.
Consarctic® supports leading pharmaceutical companies such as BioNTech, Bayer and GSK with cryoproducts and services that meet the highest regulatory requirements.
In the early phase of drug development, thousands or even millions of chemical compounds are tested for their potential efficacy. The biological test systems - often cell lines or tissue sections - must be available in the highest quality and reproducibility.
Pharmaceutical companies maintain so-called master cell banks and working cell banks. The Master Cell Bank is the original, characterized cell line that serves as a reference. The Working Cell Bank is expanded from it and used for daily trials. Both bank types are stored cryopreserved in nitrogen tanks and require the highest safety standards.
Once a promising drug candidate has passed initial screening, preclinical studies follow - first in vitro (on cell cultures) and then in vivo (on animal models). Cryotechnology is also required here.
In toxicological studies, tissue samples from treated animals are cryopreserved and stored for later histological examinations. The quality of the freezing process determines whether the fine structures of the tissue are preserved for analysis.
In clinical phases I to III, drugs are tested on increasingly large patient groups. The cryogenic infrastructure supports this process on several levels.
Large clinical trials are often conducted simultaneously at dozens of clinics in different countries. Blood samples, biopsies and other patient samples need to be transported from the trial site to the central laboratory for cryopreservation. The Cryo Transport Containers of the Consarctic® ASR+ series ensure safe and validated transportation, even over international distances.
Increasingly, biomarker samples are also being collected in clinical studies for the purpose of personalized medicine. These samples often have to be stored for decades, as they enable retrospective analyses that were not planned at the time of the study.
For pharmaceutical companies operating in a highly regulated environment, the origin and quality of their laboratory equipment is a crucial factor. Consarctic® manufactures its cryogenic systems in Germany in compliance with ISO 13485 and ISO 9001 standards and provides full IQ/OQ documentation for every piece of equipment.
The 24/7 emergency service ensures that valuable samples remain protected even in the event of unforeseen events - because the loss of a cell bank or a clinical sample collection can set back the entire development process by years.
In pharmaceutical research, cryopreservation is often regarded as a purely supportive function. In reality, however, it is a strategic success factor: it ensures the reproducibility of experiments, the integrity of regulatory samples and ultimately the future of new therapies.
Are you looking for a reliable partner for the cryogenic infrastructure of your pharmaceutical research? The experts at Consarctic® are at your side - from the initial consultation to turnkey laboratory equipment.