Global demand for genetically modified therapies like cell & gene therapies along with mRNA vaccines has spiked in the last few years. With that, plasmid manufacturing market is expected to growth at a CAGR of over 20% in the coming years. To keep pace with the increasing demand, new manufacturing capacity is needed.
The most common production process is based on bacterial fermentation. Even if it is well established, the design and realization of new manufacturing facilities is not exempted of challenges. Factors like production scale (i.e.. batch size), type of plasmid (i.e. drug product vs drug substance vs starting material) as well as GMP requirements (i.e. multi-product, contamination control, risk based approaches) will determine the design and future operations.