BPRC has already made great strides in the development of alternative research methods. Now our experts have come another step closer to this objective, with the engineering of an animal-free method to detect impurities in new types of medicines – impurities that can cause dangerous side effects.
Drug safety is an important issue. That's a given. But while most newly developed 'biopharmaceuticals' have passed all the safety tests, it's not uncommon for them to induce a severe inflammatory response, known as adverse immunostimulation (AI), once actually administered in humans. Recently, a team of researchers at BPRC and the Leiden Centre for Human Drug Research (CHDR) analysed how often this happens, and why. Click here to read the full article.
New animal-free method
It turns out that many new types of drugs (biopharmaceuticals) contain minuscule impurities of microbial origin, whereas the safety screening required under current regulatory guidelines tests for only one kind of impurity (endotoxins). Microbial and other kinds of impurities go undetected by these tests, even though they can have dangerous side effects in patients.
BPRC's Alternatives Unit now has developed two animal-free methods to measure innate immune responses. Known as ‘bioassays’, these methods are sensitive enough to detect such impurities. The article's authors therefore recommend the use of bioassays like these whenever screening biopharmaceuticals for safety and purity.
BPRC is of course best known as a primate research centre. The overarching objective of all our work is to solve medical problems, and to do so using animal-free methods to the greatest possible extent. As such, one of our focus areas is to research potential alternatives to animal testing. This is all the more vital when these kinds of innovations can aid in the development of new drugs and treatments for serious illnesses.