Do you recommend outsourcing or manufacturing plasmid DNA internally?
This question is part of the following Ask The Expert session:
Plasmid DNA Production for Cell and Gene Therapy
Job Title: Associate Director, EMEA Segment Development for Cell and Gene Therapy
Today, most if not all pDNA manufacturing is being outsourced to specialized manufacturers and CMOs. With the increasing demand of pDNA within the biopharma industry, demand for appropriate manufacturing capacity and expertise is also increasing. This rises the need to build long-term solutions to be ready to cover future market needs and ensure supply integrity by investing in inhouse pDNA manufacturing.
The cost of outsourcing is quite high, requiring highly specialized expertise and manufacturing facility. At the same time, building a pDNA production facility with the required expertise and capabilities is also costly investment. Both options have pros and cons and making decision about manufacturing your plasmid DNA in house or outsourcing it would require a strong cost assessment study for each option taking into consideration the availability of the required expertise and facility in alignment with the company short- and long-term vision.
For example, a company using pDNA as raw material for viral vector production or mRNA synthesis would have a different vision and need compared to a company using pDNA as a final product for vaccine or direct gene transfer therapy. In other words, outsourcing the core activity of a company is different from outsourcing part of the process.
Outsourcing enables to benefit from required competencies and capabilities along with quality, efficiency, productivity and speeding time-to market. However, it is important to carefully select the partner based on the experience they have on the field, quality management systems, timelines and successful regulatory inspection history. Outsourced work is an extension of your business, so it is important to find the right partner with similar values as your own company.