Many drugs interact with our blood, either after injection or uptake via our digestive system. Protein drugs are mostly directly administered via the blood stream, therefore a valid question is: will the drug activate an immune response?
Our immune system keeps us safe against the invasion of harmful agents, such as bacteria, viruses, fungi, and non-human proteins and DNA. The first line of defense is the innate immune response, followed by the production of specific antibodies for long-term protection. One major component of the innate immune response is the complement system, which can be divided in three pathways. One protein (C3) active in all three pathways produces a measurable product, the protein C3a, which acts as a first indicator that the complement system was activated.
We have designed a module, which measures the level of complement activation in human plasma of a drug formulation, either directly applied, or harvested from our protein production module: IN-CAS (in-line complement activation screening). The amount is determined with rapid, single angle SPR based on ELISA* principles.
Module status: designed.