Immunotherapy Workflow - Step 6. Quality Control

Quality experts conduct tests on the cells ready for injection back into the patient to confirm IdentityPuritySafety and Potency (*1).
The life of patients relies on the quality of the immunotherapy product. In accordance with GLP, each stage of production is subject to quality controls:  
Control of production materialsIn-process control & testingrelease testingvalidation of the production processstability study, …
Good practices, recommendations and guidelines are provided by the European Medicines Agency and controlled by the Committee for Advanced Therapies (CAT) who is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

Contact us

quality control QC in Immunotherapies ATMP Cell and gene therapies

​Your challenges

  • ​How to check purity and effect of other cell types and carry over from manufacture? What can I use as Cell based standards?
  • Are you prepared to automated high throughput sample analysis and cell culture automation?
  • How precise is your automated handling of small sample volumes?
  • Is your cell counting and viability analysis method automated, easy and reliable? Can you answer data integrity questions from auditors?

Ask our experts

​Our Solutions for your Workflow

  Cell culture QC lab 

Flow cytometry QC Lab 

Biochemistry QC lab 

Molecular Biology QC lab 

Microbiology QC Lab 

Raw Material QC Lab

Lab Furniture 

​Quality control testing categories

In general, quality control testing is also classified into the following categories: 

Control of production materials

The substances or materials used in the preparation of the cell therapy product includes cells, vectors for gene modification, culture mediums, cytokines, various additive components, cryoprotectants, excipients, and so forth. The materials used for production are directly related to the quality of the products. Therefore, researchers should establish a good and standardized quality management system for production materials, including risk assessment of their use, auditing of suppliers, and quality testing.

In-process control & testing

These control and testing includes monitoring process parameters and achieving the objectives of process control, and the quality of cells during the preparation process.
Goal is to ensure the  repeatability  of the production process and  batch-to-batch consistency  of the final products.

Release testing

These final tests are conducted in order to ensure that the product’s identity, purity, safety, and effectiveness meet the requirements. These characteristics of the cell products should be tested by means of various methods, with the products being released only if they are qualified and certificated. Also for clinical trials, quality control items should generally include product identification, biological efficacy, purity, impurities, cell number (i.e., live cell count, number of functional cells, etc.), and general detection (e.g., sterility, mycoplasma, endotoxin, and appearance).

Validation of the production process

For the whole process, comprehensive process characterization and process validation of multiple continuous batches (at least three batches) of production are required.

Stability study

Well-controlled cold chain transport and storage play an important role in ensuring the quality of cell products and preventing the occurrence of bacteria and mycoplasma contamination. It is recommended that the investigative items include cell characteristics, biological potency, cell purity, number and ratio of living cells, cell count, and safety-related tests.


(*1) Potency test

Biological activity is the specific ability or capacity of the product to achieve a defined biological effect.
Potency test is the measure of the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product, which is linked to the relevant biological properties.
One of the requirements included in  Directive 2003/63/EC (Annex I, part IV)  is that human somatic cell therapy medicinal products are made of a defined number (pool) of viable cells. Cell viability is an important parameter of product integrity and may be used as an in-process control after manipulation of certain cell characteristics e.g. up-regulation of cell surface expression of specific antigens after cytokine treatment. Cell viability may also be an important element of the potency of cell based products. However, it should be linked with other measures of potency that demonstrate the potential for biological activity of the product, such as quantitative antigen expression or biological activity as measured in the bioassay.

Cell Volume: One Crucial Indicator Among Many in White Blood Cell Health


Cell volume is an important indicator of white blood cell health and therapeutic potential - Beckman Coulter

Rich Jones, Ph.D., gave a talk at Phacilitate Leaders Summit and World Stem Cell Summit titled "Cell volume is an important indicator of white blood cell health and therapeutic potential". Dr. Jones compares 3 technologies for determining cell volume.

Sources and references

  Yonghong Li, Yan Huo, Lei Yu, Junzhi Wang, Quality Control and Nonclinical Research on CAR-T Cell Products: General Principles and Key Issues, Engineering, Volume 5, Issue 1, 2019, Pages 122-131, ISSN 2095-8099,

Committee for medicinal products for human use (CHMP)  Guideline on potency testing of cell-based immunotherapy medicinal products for the treatment of cancer | European Medicines Agency ( . EMA/CHMP/BWP/271475/2006 rev.1 – Adopted 21 July 2016