Freqently Asked Questions

4basebio offers three distinct quality grades of its synthetic DNA; Research Use Only (RUO), High Quality (HQ), and GMP critical starting material and drug substance.  Our manufacturing facility received a GMP certificate and a Manufacturing and Importation Authorisation for Investigational Medicinal Products (MIA-IMP) in Q1 of 2025, enabling us to supply GMP-grade critical starting material and drug substance for your program.   

4basebio produces and utilizes circular, plasmid backbone-free DNA templates that are directly fed into cell-free amplification reactions. The templates can be produced using wide array of starting DNA material ranging from de-novo synthesized DNA fragment blocks to plasmid DNA. 4basebio can accept initial DNA material from the client if preferable, commonly requiring amounts of up to 100ug of DNA. Our experienced molecular biology team will advise on the best strategy for your custom project. 

Our standard turn-around time for RUO grade material is 8-10 weeks, which includes time for us to generate your starting material, produce the circular backbone-free DNA template, amplify the cell-free master template, and purification and QC. While this timeline is slightly longer than traditional plasmid starting material at this scale, our enzymatic-based manufacturing process significantly improves the safety and speed at larger scales. Our process does allow for a fully synthetic process, and we work with many of the leading providers to secure the gene fragments.  

4basebio can manufacture GMP-grade synthetic DNA in as little as 12 weeks compared to the 16+ weeks of traditional plasmid DNA.

On our standard CoA, we provide standard QC assay results including appearance, concentration, endotoxin, identity, residual host protein, sterility, and bioburden.  

Due to our manufacturing process not requiring the amplification of a bacterial based backbone, we do not provide assays for residual host genomic DNA, residual host RCA, restriction digest, and detection of Kanamycin.   

Plasmid DNA production involves bacterial fermentation, which introduces risks of endotoxin contamination, residual host cell proteins, chromosomal DNA, and RNA that must be removed through extensive purification. 4basebio’s synthetic DNA technology platform is produced through cell-free enzymatic synthesis, avoiding bacterial components entirely and resulting in a cleaner starting material with a simpler purification profile for downstream manufacturing.

Plasmid production requires maintaining bacterial cell banks, fermentation infrastructure, and longer lead times (typically weeks) for production scale-up. Synthetic DNA can be manufactured more rapidly (days to weeks depending on complexity), doesn't require biological systems, and offers more flexible, on-demand production. This makes synthetic DNA particularly advantageous for rapid response applications like pandemic vaccines or personalized cancer vaccines where speed and adaptability are critical.

4basebio will create a customized solution for the storage of your master synthetic material. Please contact our Business Development team for more details on this custom service.  

You can order your custom synthetic DNA constructs directly with one of our Business Development team members. Email us at info@4basebio.com or complete this request via a quote form.