Althea Technologies, Inc. Offers Full Scope Custom Integration Study Assays For DNA Vaccines
Studies include a complex protocol of procedures designed to separate high molecular weight DNA from low molecular weight plasmid-derived DNA
San Diego — October 19, 2000 — Althea Technologies, Inc., announced today that they now offer a full scope custom Integration Study to test for genomic integration of plasmid DNA vaccine products in injected animal muscle tissues. Each study includes a complex protocol of procedures designed to separate high molecular weight DNA from low molecular weight plasmid-derived DNA with a custom designed very sensitive and specific quantitative real time PCR amplification assay.
When a plasmid construct is selected for clinical development of a plasmid-based genetic vaccine, it is critical to determine if any level of plasmid DNA integration into host cell genomic DNA will occur. The FDA now requires that an integration study be conducted to confirm that integration is either absent or at what is considered to be an “insignificant” level. A key factor in this determination is the limit of detection of the assay used to evaluate the plasmid DNA level. Althea’s quantitative real time PCR TaqMan chemistry based system can measure down to less than 5 copies/mg DNA level and is ideally suited for gene integration evaluation.
Althea scientists will work closely with the research investigator who designs and completes the animal studies. Once the tissues are dissected and transferred to Althea, Althea scientists begin a complex protocol of procedures designed to separate high molecular weight DNA from low molecular weight plasmid-derived DNA in animal muscle tissue samples that have been injected with a plasmid DNA vaccine product. Total DNA is extracted from the injected tissue samples and then fractionated using a unique tube gel electrophoresis system. This process separates the extrachromosomal plasmid DNA from the high molecular weight genomic DNA. The high molecular weight genomic DNA is purified, and a sample is run using plasmid specific primers and probes in a custom designed quantitative real time PCR amplification assay. Throughout the testing process, Althea scientists adhere to the specific guidelines outlined at the American Society of Gene Therapy meeting on May 31, 2000 by Anne M. Pilaro, Ph.D. of the FDA/ CBER branch. On completion of the Integration Study work, Althea provides a detailed FDA-ready custom report.
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Althea Technologies, Inc. is a privately held company dedicated to accelerating gene –based drug development. The company specializes in two areas: custom designed PCR gene quantification services using Taqmanä chemistry and the cGMP or non-GMP multi-gram production of custom, highly purified plasmid DNA for pre-clinical and clinical genetic research studies. The company is located in San Diego, California.
For additional information about the company visit the Althea website at www.altheatech.com or contact the company at 888-4-ALTHEA or 858-455-2183.