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New Therapeutic Modalities

At Concept life sciences we support many new drug modalities. These innovative approaches in drug development go beyond traditional small molecule drugs. Examples include targeted protein degraders, gene therapies, RNA-based therapeutics, and antibody drug conjugates. Discovery and preclinical testing for these modalities involves assessing safety, efficacy, and pharmacokinetics in laboratory and animal models. For gene therapies, this might include testing in cell cultures and animal models to ensure targeted gene delivery and expression. RNA-based therapeutics, such as mRNA vaccines, undergo preclinical testing to evaluate their safety profile and effectiveness in inducing desired cellular responses. Targeted protein degraders also require bespoke design beyond the classical rule of 5 with adapted bioassays elucidated the complex pharmacology associated with their mechanism of action.

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A more in-depth view

In addition, we can support GMP release testing for cell therapy products This testing is critical to meet regulatory requirements and maintain product consistency. Key aspects of GMP release testing for cell therapy products may include:

  1. Identity Testing: Confirming that the cells in the final product are indeed the intended cells, often through genetic or phenotypic analysis.
  2. Potency Testing: Assessing the therapeutic effectiveness of the cells by evaluating their ability to perform the intended biological function.
  3. Viability Testing: Verifying the viability and functionality of the cells, as viable cells are crucial for the therapeutic effect.    

These tests collectively ensure that the cell therapy product meets predefined specifications and is safe for administration to patients. The specifics of GMP release testing can vary based on the nature of the cell therapy and regulatory guidelines.