How enzymatically produced synthetic DNA is accelerating the future of next-gen therapies
For decades, plasmid DNA (pDNA) has been a key starting material for next generation therapies. With its inherent challenges and an increasing demand for DNA, there is a need for new alternatives to the plasmid-based approach. This is why 4basebio’s synthetic DNA was developed, to offer a faster, cleaner and safer alternative to pDNA.
In a recent interview with Drug Discovery News, Amy Walker, Chief Operations Officer at 4basebio discussed the advantages of synthetic DNA and its impact on the development of gene therapies. With 4basebio’s recent good manufacturing practice (GMP) certification being approved, find out what that means for you!
The full article is worth a read, but if you’re short on time, here are some highlights.
Addressing the challenges of DNA sourcing for drug development
One of the biggest pain points our clients experience is sourcing high-quality DNA in a timely and scalable manner. Traditional plasmid production often comes with lead times of 9 to 12 months. “4basebio’s enzymatic synthesis cuts this to as little as 8 weeks from sequence to product, an advantage that can dramatically shorten development timelines” Amy said.
In addition to speed, 4basebio offers unparalleled flexibility. Traditional plasmid manufacturers often require large-scale production using bioreactors. In contrast, 4basebio’s scalable enzymatic process can produce synthetic DNA in quantities tailored to the customer’s needs. This minimizes waste and reduces cost, making it ideal for personalized medicine and mRNA-based therapies that require smaller, customized batches.
“Our mission is to accelerate the development of next generation therapies by delivering high-performance synthetic DNA with significantly shorter lead times and performance benefits as compared to traditional plasmid-based methods.”
Amy Walker
COO
Tailored DNA formats for targeted applications
A unique strength of 4basebios synthetic DNA lies in its portfolio of customizable application-specific DNA formats:
opDNA®: Designed for mRNA production, it features an open 3' end, removing the need for enzymatic linearization and simplifying the workflow.
hpDNA: Ideal for viral vector production, particularly adeno-associated virus (AAV) applications, this format eliminates bacterial backbones, reducing cost and enhancing safety.
osDNA®: Allows researchers to tune innate immune activation, offering precise control over immunostimulatory responses in various applications.
oeDNA®: Ideal for gene editing applications, specifically to enable precise insertion via homology-directed repair (HDR)
“All 4basebio molecules can facilitate DNA dose reductions in downstream applications due to lack of bacterial backbone.” Amy adds.
GMP certification: Enabling clinical-grade DNA production
The recent GMP certification received by 4basebio, has been a major milestone for the company and future customers. It ensures faster access to clinical-grade synthetic DNA, simplifies regulatory navigation, and reduces development risk. 4basebio can now support customers from early-stage development through to clinical applications. With access to custom research use only (RUO) grade material for initial discovery/pre-clinical studies you are supported through to high-quality grade DNA for late pre-clinical studies and finally move on to GMP grade material can be used for further clinical applications. “This enables a smooth transition into regulated development by using high-quality material that is representative of GMP quality material that will be ultimately required for clinical application.” Amy concludes.
Check out the full article to learn more about 4basebio’s synthetic DNA platform and how it can accelerate your development pipeline.