In the ongoing shift of biologics manufacturers to single-use systems, Cytovance®, a leading biopharmaceutical CDMO, announced the addition of an integrated single-use platform for the manufacturing of plasmid DNA (pDNA) at their facilities in Oklahoma City, OK. According to the company, two grades are available (Critical Reagent Grade™, CGMP-grade) in lot sizes from 1g to 50g, and one grade is available (R&D-grade) in lot sizes from 1g to 5g.
Given the increasing growth in the gene therapies market, the plasmid DNA contract manufacturers are likely to witness an increase in demand in the coming years. In fact, the cell and gene therapies market has grown exponentially in the last few years. As per the Alliance of Regenerative Medicine’s recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene therapies. With over 2,600 clinical trials registered to date, cell and gene therapies are playing in a league of their own. The increased demand for these therapies has created new opportunities for vector manufacturers.
One of the key takeaways from a recent market report by Roots Analysis is that the demand for vectors is high, raising sponsor companies’ expectations from manufacturing service providers for solutions to deal with the growing need to address the existing capacity shortage. The adoption of novel technologies by manufacturers is expected to help the companies significantly overcome the demand vs supply gap in this market.
Here is an excerpt from the report by Roots Analysis:
“The available vector manufacturing capacity is insufficient for handling the estimated current demand. The situation is unlikely to improve as more cell and gene therapies enter the market. Left unchecked, the demand may soon overwhelm the existing capacity to supply vectors. However, stakeholders are expanding existing capabilities and upgrading legacy technologies to accommodate larger scale contracts, without significantly compromising on quality”
Another key point that the report extensively talks about is the increasing demand for alternate vector types. The report compares the current capabilities of vector manufacturers for various vector types. Below, is an illustrative figure highlighting the capabilities of manufacturers in this space, for different vectors:
As the market for cell and gene therapies matures, it will be interesting to see the strategies that different developers adopt in overcoming the capacity crunch.
To access the full report on the viral and non-viral vector manufacturing market, click here.