There is a lack of patient derived real-life clinical data to understand the clinical relevance of immunogenicity via the SC route of administration. Even the data that exists from current clinical trials does not delve deep into onset, kinetics and maturation of response following different routes of delivery. In general, there are no harmonized, industry-wide accepted in vitro or preclinical in vivo models through which multiple proteins have been tested to make comparisons across different datasets and draw broad conclusions. Harmonized models would allow correlation of the drug product attributes with safety/adverse events related to SC delivery as well as build the understanding around if immunogenic events due to SC delivery lead to long term immune response and memory. ​