What you need to know when submitting an Investigational New Drug (IND) application

A drug developers goal is to progress feasible drug candidates to the clinical phase. To achieve this they need to go through the various requirements set by regulatory bodies. To ensure you aren't prevented from progressing you need to consider assessing immunogenicity as part of your IND application.

Are you planning to submit an IND application?

This application is necessary when seeking permission from the FDA to conduct clinical trials of a new drug or biological product in humans. However, before these trials occur, regulatory bodies require thorough in vitro assays and high throughput screening technologies to ensure the drug's safety and efficacy. In this blog post, we will explore the importance of immunogenicity assessment in IND filings and how the Mixed Lymphocyte Reaction (MLR) assay can assist in this process.

What do you need for your IND application?

When submitting an IND application, you must provide detailed information about the drug's chemistry, manufacturing, controls, pharmacology, toxicology, and clinical protocols. The FDA reviews the application carefully to ensure that the proposed trials are safe and that the drug's benefits outweigh the risks. Assessing immunotoxicity is crucial because it helps identify potential adverse effects on the immune system before clinical trials begin.

The FDA places great emphasis on evaluating immunotoxicity during the drug development process. Since the immune system protects the body from foreign substances, interactions between drugs and the immune system can lead to harmful reactions. To address this concern, the FDA recommends various methodologies. One such method is the Mixed Lymphocyte Reaction (MLR) assay, which measures the response and proliferation of T-cells in an allogeneic way, providing a comprehensive assessment of immunotoxic potential.

What benefits can the MLR assay provide for your application?

The MLR assay offers several advantages. It is highly sensitive and can detect even weak T-cell responses. Additionally, it can identify immune responses to both MHC-restricted and non-MHC-restricted epitopes, providing an overall evaluation of immunogenic potential. However, interpreting the assay results can be challenging due to variations in donor cells and antigen presentation. Nonetheless, these variations can offer insights into how the drug candidate might behave in a larger population.

To streamline the IND application process, it is crucial to consider employing the MLR assay along with high throughput multiplexing assessment. This approach allows for the simultaneous analysis of multiple immune response markers, reducing time and costs. It enhances efficiency, provides a more comprehensive evaluation of the immune response, and contributes to a more accurate immunogenicity assessment.

Final considerations 

In conclusion, evaluating immunotoxicity is vital when preparing IND filings. The MLR assay, with its ability to assess T-cell immune responses, plays a critical role in this evaluation. Combining it with high throughput multiplexing assessment can expedite the IND application process while ensuring patient safety. If you want to delve deeper into this topic and learn more about the MLR assay and its applications, we invite you to download our whitepaper, which can further support your drug development journey.

Investigational New Drug whitepaper 

Mixed Lymphocyte Reaction Assay Service