4basebio: Manufacturing high-quality synthetic DNA for the genetic medicine revolution
High-quality DNA is in demand for gene therapies and vaccines to treat cancer and many other rare and devastating diseases. It’s also the starting point for mRNA vaccines, such as those used to protect people against COVID-19.
The challenge
Cambridge-based SME 4basebio has developed an enzyme-led manufacturing process that avoids using plasmids. This approach is safer and faster because it avoids the cumbersome fermentation processes required for plasmid DNA and eliminates bacterial contaminants.
As a start-up with limited bandwidth, 4basebio accessed CPI’s specialist expertise and state-of-the-art biologics facilities to scale-up and improve a central step in their purification process. We introduced a DNA polishing tool to remove impurities, developed analytical methods for checking product quality, and reviewed the regulatory landscape to ease their path to market.
CPI helped us accelerate a vital aspect of our manufacturing process to expedite our journey towards a clinical product. We’ve made significant progress in our GMP manufacturing capabilities, leading to our first DNA sales and increased interest in our products from partners and client base.
Carmen Mañas Torres, Team Leader in Synthetic DNA Purification – 4basebio
How CPI helped
- Developed analytical approaches for assessing the quality of the DNA product using high-performance liquid chromatography (HPLC).
- Provided support with scaling up and improving the downstream processing of DNA using tangential flow filtration (TFF).
- Screened different materials and protocols for the final polishing step after DNA purification.
- Consultancy around the regulatory landscape for DNA as a therapeutic starting material – such as in the manufacturing of RNA and adeno-associated virus (AAV) – or as a therapeutic itself.
- Ran a comparison between the client’s DNA and existing products on the market.
Achievements
- Developed a method for downstream purification of synthetic DNA using TFF to create a higher-quality product.
- Developed HPLC approaches to analyse impurities in the product twice as quickly and more effectively than with standard chromatography.
"*" indicates required fields