Innovative Analytical Testing: Sequencing Methods For Nucleic Acids And Advanced Therapeutics

Nucleic acids are fundamental to the creation of many advanced therapeutic products and play a pivotal role in the evolution of next-generation medicines. Ensuring that these products are manufactured and tested accurately from the outset is crucial for their success, safety, and timely market entry. Recent advancements in sequencing technologies have established new success criteria within the current global regulatory framework, enhancing the precision and reliability of these processes.

Nucleic acids, including plasmids and mRNA, are indispensable for developing vaccines as well as cell and gene therapies. In 2023, the global market for plasmid DNA manufacturing was estimated at $1.80 billion and is projected to grow at an impressive rate of 21% annually over the next seven years. This growth is largely driven by the rising demand for GMP (Good Manufacturing Practice) grade plasmids, which are essential for the clinical development of novel cell and gene therapies. Additionally, the development of plasmid-DNA vaccines is contributing to market expansion, thanks to their lower risk of oncogenesis and immunogenicity compared to other types of vaccines.

An outsourcing partner that is strategically positioned to meet this growing demand with capability to manufacture GMP-grade plasmids at a large scale, as well as a comprehensive suite of analytical methods to ensure the identity and quality of the products, can support the advancement and commercialization of cutting-edge therapies.