Thermo Fisher Scientific resDNASEQ dPCR HEK293 DNA Kit

Applied Biosystems™ resDNASEQ™ dPCR HEK293 DNA Kit

The Applied Biosystems™ resDNASEQ™ dPCR HEK293 DNA Kit is a digital PCR (dPCR)-based solution designed to quantify residual DNA from HEK293 expression systems. These systems are commonly used for the production of gene therapies, cell-based vaccines, and related biologics. This assay provides a fast and dependable method for accurately measuring residual HEK293 DNA with exceptional sensitivity and specificity. It ensures reliable and consistent quantitation across diverse sample types, including in-process samples and final product formulations.

주요 특징

• HEK293 잔류 DNA의 정확하고 절대적인 정량 분석
• TaqMan dPCR 마스터믹스 및 프라이머/프로브 세트를 포함한 통합형 시스템
• 약 3시간 내 결과 제공하는 고감도 정량 분석
• 복잡한 매트릭스에서도 정량 회수를 최적화한 수동 또는 자동 샘플 준비 지원

Digital PCR Workflow

The resDNASEQ dPCR HEK293 DNA Kit is part of an integrated digital PCR workflow for impurity testing during biopharmaceutical manufacturing.
When used with the Pharma KingFisher Apex 96 Deep-Well Magnetic Particle Processor and PrepSEQ Nucleic Acid Sample Preparation Kit, it enables high recovery of residual DNA with reduced labor and error compared to manual processing. The KingFisher Apex instrument can process up to 24 samples in triplicate, whereas manual methods typically handle only 3 samples in triplicate.

To ensure regulatory compliance, the resDNASEQ kit has been internally validated on the QuantStudio Absolute Q Digital PCR System. Data analysis is streamlined through the QuantStudio Absolute Q dPCR Software, offering accurate quantitation along with security, audit, and e-signature features to support 21 CFR Part 11 compliance.

사양 (Specifications)