Frost & Sullivan has awarded biopharmaceutical firm Cytogenix with its 2006 award for innovation in biotechnology processing for its cell-free manufacturing method that enables generation of large quantities of high-purity DNA in small highly automated production modules at a fraction of the time and cost of traditional bioprocess methods.
The market research firm deemed Cytogenix' ssDNA expression technology to be a fundamental improvement to the large-scale production of DNA, allowing it to make a market-ready vaccine from start to finish in less than three months. The need for DNA made under current good manufacturing practice (cGMP) at affordable prices is increasing as more DNA-based medicines are entering the clinic, while fears of a bird flu pandemic and a bioterrorist attack are driving governments and the pharmaceutical industry to look for rapid DNA production methods.
With Cytogenix' technology, DNA can be rapidly produced with cell-free process control that mimics the chemistry associated with small molecule production.
It therefore does not require methods for cell collection, processing, and culture maintenance, thus significantly reducing quality assurance, quality control, and compliance overhead costs compared to traditional methods.
The entire process is bench-scale and requires less equipment, less space and less human intervention compared to bioprocess manufacturing facilities.
"The total absence of bacteria and growth media means that there is no need to employ mechanical or chemical purification methods to extract cell or animal proteins, RNA, genomic DNA, and backbone molecules," says Frost & Sullivan research analyst Katherine Austin.
"This feature provides the designer more control over coding for non-specific and specific immune responses."
The final product does not require refrigeration as standard vaccines do, and this could make a significant difference in vaccination rates in countries where electricity is often not available.
The company has completed the design and construction of a prototype production module for high-quality, cell-free DNA and last month announced a follow-on order for the production of its synthetic DNA, synDNA, from an unnamed client referred by Aldevron, which provides contract services to accelerate gene and protein based research.
"CytoGenix' synDNA has been selected as the best-in-class innovation in recognition of its revolutionary potential for changing DNA manufacture," Cytogenix CEO Malcolm Skolnick said.
"Our short term goal is to develop synDNA vaccines including avian flu, smallpox and Brucellosis as well as contract manufacturing of synDNA for other biotechnology companies."
The Houston-based company is now implementing standard operating procedures to comply with cGMP to allow the production of clinical-grade material.
As the demand for dependable delivery and expression systems increases and more and more companies seek to avoid the cost of traditional fermentation methods, Cytogenix believes it is fit to win the race for better purity, price and production cycle times in DNA production.