When developing gene therapy, vaccines and other biopharmaceutical products, it’s essential to measure the body’s reaction to them to assess how efficient they are and avoid causing harm to those using them. Doing so early in the drug development process can help ensure that funds are not wasted on a drug that provokes a response that could be detrimental to the patient.
Sometimes, the human body can recognize specific treatments as foreign elements, resulting in an immune system reaction that can be more harmful than the initial condition. The immune system can produce anti-drug antibodies (ADAs), which can hamper or even negate these treatments’ positive impact, which is why immunogenicity testing is vital. Here, experts at Alderley Analytical explain the importance of ADA testing and the benefits of addressing this testing early on.
Understanding Immunogenicity
As mentioned, the human body’s reaction to a drug can work similarly to the way it does when we suffer illness. Producing antibodies is what the immune system is designed for, so it is essential to reduce the risk of this when developing treatments to avoid the following complications:
- A lower efficacy- – ADA production can reduce treatment efficacy. Not only can this lead to higher doses being prescribed to counteract this issue, but it can also cause side effects that can have a negative impact.
- Safety issues – While some immune system responses are relatively mild, such as rashes, some ADAs can cause life-threatening reactions. Patient safety must always be at the forefront of treatment development, and ADA testing is vital in ensuring treatments do not cause further harm. Early identification can ensure adjustments are made so human trials are safe to go ahead with and the risk of patient harm is minimized.
- Alteration of impact – ADAs could change how drugs are distributed around the body due to interfering with drug target engagement and how they break down and are removed. This can make it alter the effective level of drugs in the system and accurate assessment of the half-life of a drug, for example.
Benefits of ADA testing
Ironing out issues with ADAs is vital. ADA responses should be analyzed for each developed biopharmaceutical drug and as part of the broader picture of biopharmaceutical research. The biopharmaceutical industry’s reputation is built on evidential data, and ADA testing is a big part of that.
ADA testing is vital to ensure:
- Early detection of issues – Finding ADAs early on in development can allow pharmaceutical developers to make informed decisions about continuing with the development of a therapy or treatment. This can help avoid extra expenses.
- Dose adjustments – If ADAs are identified but can be worked through by giving the patient an adjusted dose, this can keep the treatment safe and improve its efficacy.
- Regulatory requirements – It is vital to meet the regulatory requirements for testing. ADA testing is a critical part of this. Should this not be done carefully and correctly, it could delay treatment or lead to it not being approved.
There are expert providers of ADA testing services that can help you understand the impact of your fledgling treatment on the immune system of those it is meant to treat. Not only can this help you meet regulatory requirements, but it can also help you assess the safety and efficacy of the treatment to make the necessary amendments if a drug is seen to provoke an unsatisfactory reaction.
