From Cells to Treatment: How Dendritic Cell Immunotherapy Is Made
In the cell therapy developed at the Centre of Excellence CREATIC, manufacturing is not a separate technical stage taking place far from the patient. The starting material is the patient's own cells, and the resulting medicinal product is individually prepared for each patient. CREATIC’s dendritic cell immunotherapy is the first product ever to obtain the hospital exemption in the Czech Republic – how is it made? And why are cleanrooms, quality control and Good Manufacturing Practice essential to its production?
Dendritic cells
How Can the Immune System Be 'Taught' to Recognise Tumour Cells?
One answer lies in dendritic cells (DCs), which are key regulators of the immune response. They can capture tumour antigens - which help the immune system distinguish foreign or altered cells - process them and present them to T lymphocytes, thereby triggering a targeted response against tumour cells.
In anticancer immunotherapy, this principle is used deliberately. Dendritic cells are obtained from the patient's blood, modified outside the body and then returned in the form of a personalised medicinal product. Their role is to activate the immune system so that it can recognise and attack the tumour.
Interleukin-12 (IL-12) also plays an important role. It is a signalling molecule of the immune system that helps activate other cells involved in the antitumour response. IL-12 supports the so-called Th1 immune response, increasing the activity of cytotoxic T lymphocytes and NK cells – cells capable of directly destroying tumour cells. The aim is a stronger and more targeted immune response in the patient.
This approach is based on the principles of personalised medicine and the Fair Medicine concept. Each medicinal product is prepared individually from the cells of a specific patient under controlled cleanroom conditions. The result is therefore not a medicine produced in large batches, but a product tailored to one patient.
One answer lies in dendritic cells (DCs), which are key regulators of the immune response. They can capture tumour antigens - which help the immune system distinguish foreign or altered cells - process them and present them to T lymphocytes, thereby triggering a targeted response against tumour cells.
In anticancer immunotherapy, this principle is used deliberately. Dendritic cells are obtained from the patient's blood, modified outside the body and then returned in the form of a personalised medicinal product. Their role is to activate the immune system so that it can recognise and attack the tumour.
Interleukin-12 (IL-12) also plays an important role. It is a signalling molecule of the immune system that helps activate other cells involved in the antitumour response. IL-12 supports the so-called Th1 immune response, increasing the activity of cytotoxic T lymphocytes and NK cells – cells capable of directly destroying tumour cells. The aim is a stronger and more targeted immune response in the patient.
This approach is based on the principles of personalised medicine and the Fair Medicine concept. Each medicinal product is prepared individually from the cells of a specific patient under controlled cleanroom conditions. The result is therefore not a medicine produced in large batches, but a product tailored to one patient.
Cleanrooms and GMP Are More Than a Technical Detail
Cell-based medicinal products are manufactured in cleanrooms, environments with strictly controlled conditions. Manufacturing must also comply with Good Manufacturing Practice, known as GMP.
GMP defines how medicines must be produced so that the process is controlled and reproducible. Each step follows a precise procedure and is documented. The final product is also tested, including characteristics such as cell properties and viability. Only once the defined requirements have been met can the medicinal product be released for administration to the patient.
Cell-based medicinal products are manufactured in cleanrooms, environments with strictly controlled conditions. Manufacturing must also comply with Good Manufacturing Practice, known as GMP.
GMP defines how medicines must be produced so that the process is controlled and reproducible. Each step follows a precise procedure and is documented. The final product is also tested, including characteristics such as cell properties and viability. Only once the defined requirements have been met can the medicinal product be released for administration to the patient.
When Manufacturing Becomes Part of Treatment
For conventional medicines, manufacturing is usually separate from the treatment itself. Autologous cell therapy is different: the process begins with collecting cells from a specific patient and ends with administering a tailored medicinal product prepared specifically for that patient's needs directly to the patient.
Manufacturing is therefore a direct part of the entire treatment pathway. The hospital exemption provides a regulatory framework that, under precisely defined conditions, allows such an advanced therapy medicinal product without standard marketing authorisation to be used in clinical practice. Requirements for quality and safety remain fully in place.
The manufacturing process of a cell-based medicinal product shows that, in personalised therapies, the technology cannot be separated from the individual patient. Every step leads to a product intended for one person. In the next article, we move from manufacturing to situations in which standard treatment options are no longer sufficient, and to the long-term experience on which today's dendritic cell immunotherapies at CREATIC are built.
For conventional medicines, manufacturing is usually separate from the treatment itself. Autologous cell therapy is different: the process begins with collecting cells from a specific patient and ends with administering a tailored medicinal product prepared specifically for that patient's needs directly to the patient.
Manufacturing is therefore a direct part of the entire treatment pathway. The hospital exemption provides a regulatory framework that, under precisely defined conditions, allows such an advanced therapy medicinal product without standard marketing authorisation to be used in clinical practice. Requirements for quality and safety remain fully in place.
The manufacturing process of a cell-based medicinal product shows that, in personalised therapies, the technology cannot be separated from the individual patient. Every step leads to a product intended for one person. In the next article, we move from manufacturing to situations in which standard treatment options are no longer sufficient, and to the long-term experience on which today's dendritic cell immunotherapies at CREATIC are built.
Continue the series
Next article: When Standard Treatment Options Are Not Enough: Personalised Therapy in Practice