Genetic Engineering & Biotechnology News

MAY15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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90% of $ saved Genetic Engineering & Biotechnology News | GENengnews.com | MAY 15, 2018 | 15 ter of excellence supported by Innovate UK, dPCR is being used in several applications related to gene therapy. Damian Marshall, Ph.D., a senior scientist at the center, said that dPCR allows measurement of viral copy num- ber at the single-cell level in cell-based prod- ucts for gene delivery rather than just look- ing at an average copy number for the whole population of cells. "The advantage of this approach is that we can look at cell-to-cell variability and see if the average value we have from a single measure of the population is currently rep- resented homogenously by the viral copy number at single cell level," he explained. "A qPCR approach wouldn't give you that information at the single-cell level." Therapies that mobilize gene-modified cells, such as chimeric antigen receptor (CAR) T-cell therapies (for hematologic malignancies) and Strimvelis (for severe combined immuno- deficiency due to adenosine deaminase defi- ciency), can use dPCR as part of their product release testing to analyze viral integration. "I don't think dPCR is much more expensive [than qPCR]," commented Dr. Marshall. "Though maybe it is a little more because we are using the Bio-Rad ddPCR system." "The advantage that you gain is large enough that in the end, dPCR is more cost ef- fective," added Vincenzo Di Cerbo, Ph.D., analytical development scientist at the cen- ter. Dr. Marshall pointed out that for a more mainstream application (that is, an application more mainstream than cell-based therapies, which are used only in a few patients), modi- fications to the single-cell isolation step to in- crease throughput might drive down cost. The Catapult center is also evaluating dPCR for sterility testing for cell and gene therapies. dPCR not only detects contamina- tion down to the single copy number level, it also distinguishes between live and dead mi- croorganisms. Dr. Marshall pointed out that cellular therapies have a limited shelf life and are intended for seriously ill patients. The current "gold standard" compendial sterility tests were developed in the 1930s and require a 14-day culture period. For cellular products with a shorter shelf life, the product may be released at risk with a mitigation plan in place in case sterility tests fail, although by that time they would already be administered. While there are more rapid tests that can re- duce test time to 2–5 days, the Catapult center is looking to decrease test time to four hours with a dPCR approach that can identify 99% of all bacterial and yeast species. The test is being validated by direct comparison to a compendial test for a cell therapy product. Digital PCR can also be used to absolute- ly quantify viral titers, either in gene-modi- fied cell therapies or for viruses that are the actual product. "In all these cases, we are using dPCR as a better tool to meet regu- latory requirements," Dr. Marshall main- tained. "You couldn't have an assay that's better." Dry in Autoclave Rinse in RNase-free water Soak in DEPC @37c for 2 hours Rinse and dry equipment KeyPro™ UV Cycle www.phoseon.com/life-sciences Rapid and reliable decontamination with UV light KeyPro™ saves Researchers TIME 0 20 40 60 80 100 120 140 160 180 MINUTES DECONTAMINATION Conventional KeyPro™ 90% of time saved KeyPro™ saves Labs MONEY DOLLARS 0 10 20 30 40 50 60 70 80 90 100 DECONTAMINATION Conventional KeyPro™ 90% of $ saved www.liebertpub.com/big Leading the Data Enabled World The fi rst peer-reviewed journal to connect a world where the pace from research to implementation is ever accelerating The go-to platform for: Advances in new big data technologies Discussion of unique and innovative big data ideas Problems, challenges, and security issues in managing big data Sharing and dissemination of world-class data science expertise OMICS Digital PCR not only detects contamination down to the single copy number level, it also distinguishes between live and dead microorganisms.

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