Delivering vaccines to all corners of the world is a complex undertaking. It takes a chain of precisely coordinated events in temperature-controlled environments to store, manage, and transport these life-saving products. This is called a cold chain.
When it comes to pharmaceutical cold chains, there are very clear regulations around the transport and storage processes, particularly within the European Union. Biomedicines such as vaccines must be continuously stored in a limited temperature range – between 2°C and 8°C – from the time they are manufactured until the moment of vaccination, because temperatures that are too high or too low can cause the vaccine to lose its potency. Once a vaccine loses its potency, it cannot be regained or restored.1 Pharmacies, hospitals, and distributors are required to monitor and audit cold storage of their biomedicines both during transportation and in stock.
These regulations may soon become even more stringent. Currently, GDP (Good Distribution Practices) make drug companies directly liable for medicine in the cold chain, from manufacturing all the way until it goes inside the patient. The new regulations, if passed, will mean the responsibility will fall on wholesale distributors to ensure that the quality and integrity of medicines is maintained throughout the supply chain. This is where Rebus Labs comes into the picture.