Advanced Therapy Medicinal Products (ATMPs) are biological medicinal products that require different procedures for clinical trials compared to traditional medicinal products.

ATMPs can be classified in three different ways – cell therapy medicinal products (CTMP), gene therapy medicinal products (GTMP) and tissue engineered products (TEP), but they can be also a combination of these classes. AMTPs is also an EU specific classification, ensuring that products that fall under the above categories are regulated as medicines throughout the different regions.

It is important to understand the nature and the manufacturing process of an ATMP for set-up and execution of the clinical development and later marketing of these therapies.

Recently one of our Senior Regulatory Executives went on an ATMP course to further their knowledge within the area.

Why did you decide to undertake this course?

There are significant differences between biological medicinal products compared to small molecules, due to the inherent variability of biological products. This course, led by TOPRA, was an excellent opportunity to learn about the key differences and considerations.

What did it entail and what did you learn about?

The course included topics on pre-clinical and clinical development, immunogenicity issues, Quality/CMC considerations, Module 3 dossier guidelines, Bioassays and considerations specific to registration of Biologicals, Vaccines, Biosimilars and Gene/Cell therapies.

The course provided great guidance on the key differences between biological products and small molecules and highlighted considerations specific to biological products of different modalities across the full product development, registration and life-cycle.

Some of the key learnings were in respect to the variability of biological medicinal products requiring more stringent manufacturing processes and process controls to ensure comparability of the medicinal product and on the need for bioassays in addition to the physio-chemical testing required for small molecules. How these requirements are then translated into the registration dossier and how the product life-cycle should be correctly managed.

What were the benefits of this course and how are they helping you in your current role?

I‘ve benefitted from expanding not just my regulatory knowledge into a new area but also by gaining further understanding of development of biological medicinal products, which helps me to better understand the regulatory guidance and reasons behind authority requirements.

How has undertaking this course helped you to help clients and projects?

Understanding the key differences between biological products and small molecules enables Callisto to provide current, prompt guidance and support to clients interested in biological medicines, vaccines, biosimilars or advanced therapy medicinal products.

I’m looking forward to further development of my knowledge on biologicals medicines with additional reading on the subject.