To our Valued Clients and Business Partners, VGXI’s top priority is to continue delivering the highest quality DNA products and services while ensuring the security and safety of our team. VGXI is actively monitoring the evolving situation and will continue to provide updates as new information becomes available. Manufacturing activities have been… Read More »
The Woodlands, Texas – January 28, 2011 Dr. Bryan Byong Jin Kim (43), President and CEO of VGX International (“VGXI”), was named as “The Most Powerful Business Leaders in Korea” in the “Biotechnology Enterprise Sector” by Fortune Korea that was held at the Millennium Hilton Hotel on December 23rd, 2010. The award… Read More »
The Waisman Clinical BioManufacturing Facility knows how important it is to maintain strict cleanroom cleanliness and sterility because, if contaminated with microorganisms, the products the WCBF manufactures could adversely harm patients. The Clean-Don technology from Kimberly-Clark Professional is their new approach to sterile gowning. Learn how this new product shortens gowning time… Read More »
The new CellBase CT system, which was developed in collaboration with leading cell therapy experts, can be used in a GMP facility for rapid scale up of existing manual cell culture processes in T-flasks. CellBase CT provides researchers with a fully-contained, aseptic cell expansion area where the risk of external contamination or… Read More »
This study evaluated prophylactic and therapeutic effects of the IL-13Rα2 cDNA vaccination in syngeneic animal models of melanoma, sarcoma and breast cancer cells expressing IL-13Rα2 to prime the immune system. CTL activity and IFN-γ release was measured in mice vaccinated with prophylactic IL-13Rα2 DNA and boosted with ECDα2, resulting in higher measurements than DNA… Read More »
This study confirms that enhanced cellular immune responses result in mice via chimaeric Gag VLPs incorporating GagRT and GagTN as vaccine boost candidates to a pVRCgrttnC DNA priming vaccine for HIV-1. The DNA prime/mixed VLP boost vaccination increased the cumulative Gag- and RT-specific IFN-γ responses relative to two DNA vaccinations 4-fold, and… Read More »
A plasmid is extra chromosomal DNA that is not incorporated in the main helix of genomic DNA. Plasmids occur in nature and can be found everywhere – in plants, insects, and bacteria. Scientists have discovered various applications for plasmids including gene therapy and DNA vaccines. These applications deliver the plasmid to a… Read More »
Baylor College of Medicine, in conjunction with The Methodist Hospital Research Institute, has developed a way to use minivector DNAs in gene therapy. These reduced sized DNA vectors (as small as 300bp) have high gene silencing capabilities and high serum survival lengths with low replenishment requirements. In addition, the study shows that… Read More »
Cell banking is essential for a biological product manufactured by the fermentation process, such as plasmid DNA. Particular emphasis is given to cGMP cell banks by following the regulatory standards (21CFR610). But how do you generate high quality cGMP cell banks, and what are considered important attributes? Guidelines do not tell us. First,… Read More »
As a QA Manager for a plasmid manufacturer, I am always looking for innovative ways to maintain a focus on cGMP and help employees understand its importance. cGMP training accomplishes this, but it only occurs once or twice a year in most organizations. If you do not have a dedicated training department, it… Read More »
Arguably, the most challenging step in plasmid manufacturing is cell lysis. Thousands of times larger than a typical small molecule pharmaceutical API, a plasmid is a large circular molecule that most of our clients prefer in the supercoiled form. Several things can go wrong if the lysis step is too harsh. First, the… Read More »
One of the major challenges of plasmid manufacturing is cleaning validation. To avoid excess costs and time, disposable technology can decrease validation needs for both the cleaning and sterilization processes of fixed equipment systems. Disposable materials for use in pharmaceutical manufacturing have come a long way from traditional reusable technology. From pipettes… Read More »
Most companies struggle with how to make cGMP training more fun and exciting. As the Quality Assurance director of a company that provides contract plasmid manufacturing, it seems almost impossible for me to find time to be creative. This year for the “dreaded” cGMP training we played a game – yes, a… Read More »