Masterarbeit

Regulatory considerations for CMC development of platform based mRNA vaccines ***

Alexander Reichenbach (2024)

Summary
Language: English
In the field of medical research, continuous innovation has led to significant advances in healthcare. Vaccines based on messenger RNA (mRNA) are a remarkable breakthrough, signaling a fundamental shift in vaccination strategies. The versatility of mRNA technology holds immense promise for proactively combating infectious diseases. Its ability to rapidly adapt and integrate adaptations during development and production makes mRNA a key tool in combating future infectious outbreaks. However, from regulatory perspective, there is still much potential for mRNA vaccines to fulfill their role as rapidly adaptable tools in the fight against global infectious diseases. New mRNA vaccines are currently being independently assessed, requiring all clinical trial or market applications to be supported by product specific data. The high degree of similarity between the products raises the question of whether prior knowledge and data from other products can be used in a supportive manner to reduce the effort required to create product specific data. This ultimately raises the question of whether a platform can be created on which products can be referenced, thus reducing the need for product-specific data.
This thesis takes up the approach of a platform for the quality of mRNA vaccines and explains how the establishment of a platform could succeed on the basis of a quality by design model, taking into account the current regulatory landscape. It also provides an overview of where elements of the manufacturing process and the product itself could be platformed.
Summarized, detailed guidance for platformization of mRNA vaccines and leveraging from prior knowledge is only limited available, but with a suitable approach to generating the supportive data, there is an opportunity to benefit from a platform in many areas of the manufacturing. This needs to be properly defined for this purpose, but can then contribute to faster development and approval of mRNA vaccines.
Pages: 83 / 100
Annexes: 0, Pages: 0