BOULDER, CO–(Marketwired – January 19, 2016) – ViroCyt®, the leader in rapid virus quantification, announced today the release of the most recent addition to its ViroTag® portfolio: ViroTag AAV2-3. When combined with the Virus Counter® 3100, this reagent enables real-time quantification of Adeno-associated virus serotypes 2 and 3, both of which are currently being developed as gene therapy vectors for a variety of different diseases.
Following notable setbacks during the previous decade, the gene therapy field is resurgent, both in the breadth and the depth of different applications being pursued using this approach. With this continued success, however, comes the realization of the challenges inherent with transitioning from early research and development to late-stage clinical trials and product launch.
“A primary issue is the consistent and compliant production of viral vectors at levels necessary to support commercialization,” according to Dr. Michael Olszowy, Chief Technology Officer at ViroCyt. “As the number of successful trials grows and the likelihood of multiple product approvals increases, the realization that current manufacturing technologies have not kept pace highlights this as an area in urgent need of innovation.”
One of the most problematic steps is in the quantification of viral vectors during growth, harvest, purification and release. Traditional methods such as qPCR and absorbance readings at 260 nm and 280 nm are highly variable, resulting in over- or under-estimation of particles present at any given step.
Said Dr. Derek Hei, Director of Waisman Biomanufacturing, “There are currently in excess of 100 clinical studies underway using AAV-mediated gene therapy across a broad spectrum of diseases, including hemophilia, heart disease, muscular dystrophy, cystic fibrosis and Alzheimer’s disease. While the most often used method for quantifying AAV is qPCR, it is generally recognized in the AAV community that qPCR is at best an indirect readout of particle number, and results for the same sample can vary significantly. The ViroTag method for rapidly assessing viral particle concentration provides a valuable tool for use in process development, in-process testing, and release testing of AAV.”
ViroCyt has developed a novel approach enabling direct, biologically-specific quantification of viruses in minutes rather than the days or weeks required by more traditional methods. Marketed under the tradename ViroTag®, this new product category utilizes a fluorescently-labeled, high-affinity antibody targeted to the virus of interest. During a 1-minute sample analysis, the preparation is evaluated with the Virus Counter® 3100, an instrument developed expressly for the purpose of real-time virus quantification.
About ViroCyt, Inc.
ViroCyt, Inc. was created with the goal of bringing game-changing solutions to the Life Science industry. Our primary focus is replacing outdated technologies that slow down the pace of virus-related research and product development. Additional information can be found at http://www.virocyt.com.
About Waisman Biomanufacturing
At Waisman Biomanufacturing (http://gmpbio.org/), our goal is to accelerate the advancement of novel biological therapies and vaccines by offering the manufacturing and support services required for cGMP production of drugs used in human clinical trials. Waisman Biomanufacturing has a proven track record for producing high-quality clinical trial material for both large and small biotech companies, universities, and federal agencies such as the National Institutes of Health.