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Whitepaper
Strengthening investigational new drug applications with a mixed lymphocyte reaction assay
Regulatory bodies have provided recommendations for in vitro assays and to leverage high throughput screening technologies to increase the likelihood of rapidly moving therapeutic candidates into clinical trials.
This white paper discusses the requirements of regulatory bodies and how a rapid immunogenicity assessment screening can provide invaluable support for your application.
In this white paper you will learn:
- What an investigational new drug filing is
- Why assessing immunogenicity of therapeutic candidates is crucial for IND filing
- The advantages and limitations of MLR assays for an IND filing
For research use only. Not for use in diagnostic procedures.
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Strengthening investigational new drug applications with a mixed lymphocyte reaction assay