(Newswire.net — June 18, 2021) –The recent COVID-19 has turned our focus to medicine, research, and our health. There is a greater curiosity today to understand how different foreign substances such as viruses and vaccines impact our body, their role on our overall health, and ways to remain safe and healthy at all times.
One of the central aspects of this discussion is immunogenicity. What is it really and how is it relevant in the current pandemic and a post-COVID world? How can it impact our health in the future? Let’s figure it out.
What is Immunogenicity?
Immunogenicity is the ability of different substances to trigger or provoke the immune system in humans and animals. What this essentially means is that vaccines and antigens can cause an immune system to act in a specific way such as develop antibodies, and this is the fundamental concept that drives vaccinations today.
On the flip side, immunogenicity is also unfortunately what causes immunosuppressant conditions where the body attacks its own system. So, this is like a double-edged sword that can augur well for your health when implemented effectively and accepted well by your body.
What impacts immunogenicity?
Human beings vary greatly in terms of their body composition, so it’s hard to expect that their immunogenicity will be alike. In fact, there are a host of factors that go into determining how a particular antigen will impact a human.
Other than the body composition itself, some factors that can have an impact on the effect of antigens are:
- Allelic differences between the patient and the product
- Immune privilege at the site of administration
- Maturation status of the cells
- Need for multiple administrations at the same or different site
- Immunological basis of the disease itself
- Age of the immune system
- Presence of pre-existing conditions
- Genetic composition of individuals
- Possible transplantations or surgeries
- The blood group of the individual
- Histocompatibility of the antigens that are administered
Since so many factors are involved, it’s no doubt that immunogenicity is complex and the results vary greatly. This is why most studies and complex administration of antigens require a preclinical immunogenicity study that could include anti-PEG assessments, cell-based and ligand-binding based neutralization arrays, isotyping assays, biosimilar studies, and more.
Preclinical immunogenicity
Besides vaccines, another area where immunogenicity comes in handy is the preclinical tests and trials.
Though preclinical immunogenicity cannot accurately predict the level of immunogenicity in humans, it helps to understand the body composition and toxicity levels and hence, plays a big role in understanding the impact of antigens on a typical body type.
Of course, such trials have to be conducted in laboratories that are equipped for effectively handling immunogenicity using the appropriate equipment.
Typically, the laboratory you choose must have the following:
- Custom drug labeling
- PC characterization
- Optimal MRD and drug tolerance
- ACE and SPEAD adapted methods
- Pre-validation cut point assessment
- Balanced design
- Cut point setting
- In study cut point assessment
Such an advanced laboratory facility becomes essential for accurate preclinical immunogenicity that can give insights into the efficacy of certain drugs and vaccines.