Medical science is making treatments more precise and personalized. Advanced Therapy Medicinal Products (ATMPs) are changing the way serious diseases are treated. These treatments use cells, genes, and tissues to help the body heal in new ways, sometimes even curing diseases.
Medimo Oy is an expert in the ATMP field. Its job is to make sure these medicines meet high-quality and safety standards before they are used. Medimo’s specialists work with pharmaceutical companies to ensure every ATMP is developed and produced correctly.
One of Medimo’s key experts is Sanna Tuhkala, who works as a Quality Expert. She has extensive experience in the pharmaceutical industry, especially in the Qualified Person (QP) role. She has worked as a QP for both sterile medicines and ATMP products.
Before joining Medimo, Sanna worked at FinVector, where she learned about ATMP production and safety requirements. She believes ATMPs will make healthcare more effective and personal.
What are ATMP products, and how are they different from traditional medicines?
Sanna Tuhkala explains that ATMPs are advanced medical treatments that can help when traditional medicines do not work.
Unlike regular medicines, which are chemical-based, ATMPs are living medicines made from cells or genetic material. This makes them much more complex to develop and produce.
ATMPs are divided into three types:
- Gene therapy products – These fix or replace faulty genes to treat diseases. They can help with rare genetic disorders where a damaged gene is replaced with a healthy one.
- Cell therapy products – These use modified patient cells to treat diseases like cancer. A well-known example is CAR-T cell therapy, where a patient’s immune cells are changed to attack cancer cells more effectively.
- Tissue-engineered products – These help repair or rebuild damaged tissues. They are used in burn treatment and severe injuries to help the body heal itself.
One of the most promising ATMP treatments is CAR-T cell therapy. In this process, a patient’s T-cells are modified in a lab to find and destroy cancer cells. This treatment has improved cancer care by making cancer detection and destruction more precise. Since the treatment is custom-made for each patient, it works better and causes fewer side effects.
According to Sanna, ATMPs could help treat many diseases, including cancer, eye diseases, heart diseases, and rare genetic disorders. In the future, some ATMPs may work with just one dose, changing how long-term illnesses are treated.
Medimo’s role as an ATMP expert
ATMPs are very different from traditional medicines, so strict quality control and regulations are needed. Medimo Oy helps pharmaceutical companies meet these requirements before ATMPs are approved for use.
Sanna Tuhkala works at Medimo as an expert in ATMP quality assurance and regulatory compliance. She has deep knowledge of medicine production and laws. ATMPs are more complicated than regular medicines because they are made for individual patients instead of being mass-produced. However, larger batch sizes are also possible if the product is not specifically tailored to an individual patient. Each batch must be safe, effective, and sterile before it is used.
Sanna explains that ATMP development requires teamwork. Medimo’s role is to help companies follow regulations and bring safe and effective ATMP treatments to patients.
The importance of a QP in ATMP quality control
Sanna Tuhkala is qualified to work as a Qualified Person (QP) for ATMP products, meaning she is certified to work in a company that requires a QP or Quality Expert. This role ensures that every batch meets legal and quality requirements before patients receive treatment.
Sanna emphasizes that while ATMP quality requirements vary by case, all medicines—whether tablets or ATMP products—must follow the same basic principle: they must be effective and safe for the patient. Since ATMP products contain living cells or genetic material, quality control is more challenging due to variability in raw materials, making sterility and strict monitoring processes even more important.
Being a QP requires deep knowledge and teamwork with experts in research, production, and regulations. Sanna finds her work challenging but rewarding, as she helps bring new medical treatments to patients safely.
The future of ATMPs
Sanna Tuhkala believes ATMPs will play a bigger role in medicine in the future. Their development is moving quickly, and they are expected to change healthcare in the coming years. Treatments for genetic diseases and cancer will be some of the main uses of ATMPs. Personalized treatments will likely become more common and affordable, helping more patients.
However, ATMP development is expensive and takes time because of strict regulations and long research processes. This can delay new treatments from reaching the market. Sanna emphasizes that researchers, pharmaceutical companies, and regulatory authorities must work together to make ATMPs available safely and efficiently.
New rules and regulations are also being introduced to improve ATMP safety and quality control. The European Union has updated sterile medicine production guidelines, and similar changes are expected for ATMPs. This means better monitoring and stricter quality controls throughout the production process.
Working together for safer and more effective treatments
Sanna Tuhkala sees ATMPs as one of the most interesting medical innovations of the future. She believes expert organizations like Medimo play a key role in ensuring these treatments are safe and follow all required standards.
She highlights that ATMP development requires strong cooperation between scientists, pharmaceutical companies, and regulators. Her job focuses on ensuring these new treatments follow high quality and safety standards, so patients can trust them.
ATMPs offer new possibilities for treating many diseases, and development is happening quickly. Sanna and Medimo’s specialists are committed to bringing these treatments safely to patients. In the future, ATMPs could revolutionize healthcare, especially for diseases that currently have no effective treatments. Medimo will continue to lead the way, ensuring these innovative therapies become a safe and effective part of modern medicine.
