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Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer (EMEA/CHMP/BWP/271475/2006)

 The guideline with the reference number "EMEA/CHMP/BWP/271475/2006" pertains to "Potency Testing of Cell-Based Immunotherapy Medicinal Products for the Treatment of Cancer." This guideline was developed by the European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) and is specific to cell-based immunotherapy products intended for cancer treatment. Here is an overview of this guideline:


1. Purpose and Scope:

The primary purpose of this guideline is to provide recommendations and regulatory guidance for the potency testing of cell-based immunotherapy medicinal products used in the treatment of cancer. Potency testing is essential to ensure the effectiveness and consistency of these products.

2. Applicability:

The guideline applies to cell-based immunotherapy products, such as cancer vaccines and adoptive cell therapies, which harness the patient's immune system to target and destroy cancer cells.

3. Definitions:

The document provides definitions of key terms and concepts relevant to the potency testing of cell-based immunotherapy products.

4. General Principles:

The guideline outlines general principles for the design and conduct of potency assays specific to the product's mechanism of action. These principles ensure that the assays accurately assess the product's intended therapeutic effect.

5. Target Antigens and Mechanisms:

It discusses the importance of selecting relevant target antigens and mechanisms of action for potency testing based on the specific cell-based immunotherapy product.

6. Assay Development:

Recommendations are provided for the development of potency assays, including considerations for assay sensitivity, specificity, precision, and robustness.

7. In Vitro Assays:

The guideline emphasizes the use of in vitro assays that simulate the interaction between the cell-based immunotherapy product and its target, providing relevant information on the product's potency.

8. In Vivo Assays:

In some cases, in vivo assays may be necessary to assess the product's potency, particularly when in vitro assays cannot adequately replicate the product's mechanism of action.

9. Validation and Qualification:

The guideline discusses the validation and qualification of potency assays to ensure their reliability and consistency.

10. Documentation and Reporting:

- It provides recommendations on the documentation and reporting of potency testing results in regulatory submissions.

11. Specificity and Sensitivity:

- The guideline addresses the importance of specificity and sensitivity in potency assays to ensure that they accurately measure the intended therapeutic effect and do not yield false-positive or false-negative results.

12. Stability Testing:

- Recommendations are provided for conducting stability testing to assess the potency of cell-based immunotherapy products over their shelf life.

13. Bridging Studies:

- If changes are made to the manufacturing process or product formulation, the guideline discusses the need for bridging studies to demonstrate that the potency assay remains relevant and consistent.


This guideline is essential for ensuring that cell-based immunotherapy products for cancer treatment are effectively and consistently evaluated for potency, contributing to their safety and efficacy. It provides a framework for manufacturers to develop and validate appropriate potency assays and communicate this information to regulatory authorities. Please note that the specific requirements and recommendations may evolve, so it's important to consult the most up-to-date version of the guideline on the EMA's official website or through regulatory authorities

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