Search ELISA Kits
Bluegene Biotech/Cellgene Bioscience Host Cell DNA Residue Detection Kits Types
Reliable Quality, End-to-End Control
-
• With 20 years of deep technical expertise, we possess a professional and efficient R&D team with extensive problem-solving experience.
• Equipped with professional 2D-AAE and LC-MS combined coverage validation analysis software, capable of providing coverage detection for antibody raw materials from different batches.
• Establish a complete electronic archiving system for research and development data. All data are electronically retained in accordance with standards, and the complete set of data required for customer audits can be provided at any time. Ensure that the data results are true and reliable, with full traceability throughout the process, and fully meet the requirements of audit compliance.
• Supported by sufficient strategic reserves of key raw materials to eliminate batch-change risks at source, our highly streamlined production system has demonstrated extreme stability across numerous historical batches, providing robust assurance for quality and efficiency.
• From R&D to production, we maintain complete autonomy over the entire process—including core technologies, the manufacturing system, and quality control. This integrated self-sufficiency guarantees reliable supply stability.
• Establish an ISO13485:2016 medical device quality management system, covering the entire lifecycle management of product development, production, delivery, and after-sales.
What is residual host cell RNA?
-
Exogenous nucleic acid contamination in host cells occurs. DNA is the main source of contamination, while RNA is considered to have an extremely low risk, but both have potential theoretical risks (such as carcinogenicity and infectivity).
RNA derived from bacteria or viruses lacks the modification processes that occur within organelles of mammalian RNA, making it easily recognizable as "non-self."
Furthermore, extracellular RNA binds to receptors, typically activated within the endosomes of immune cells (such as plasmacytoid dendritic cells and macrophages), leading to the production and release of type I interferons (IFN-α/β) and a range of inflammatory cytokines (e.g., TNF-α, IL-6), thereby triggering adverse effects.
What are the methods for residual RNA quantification?
-
Ultraviolet spectrophotometry is the most classic and rapid method, but it lacks specificity. Principle: at a wavelength of 260 nm. Disadvantages: It cannot distinguish between DNA and RNA (DNA also has absorption at 260 nm); the sensitivity is low; relatively pure samples are required; it cannot provide information on the integrity of RNA. Instruments: NanoDrop, Qubit.
The fluorescent dye method specifically binds fluorescent dyes to RNA for quantitative analysis. Sensitivity at the pg/mL level for RNA detection. Instrument: Fluorescence spectrophotometer or microplate reader.
RT-qPCR: Using cDNA as the template, adding gene-specific primers and fluorescently labeled probes for PCR amplification. It can calculate the absolute copy number of the target RNA in the sample. Instrument: Thermo 7500, etc. Advantage: It is a classic method recognized by the pharmacopoeia.
Digital PCR (dPCR): The PCR reaction system is divided into tens of thousands of microdroplets or microcavities, and the absolute copy number of the target molecules is directly calculated using the Poisson distribution statistical principle. Disadvantages: Higher cost; relatively lower throughput. Instruments: Droplet-based digital PCR (ddPCR), chip-based digital PCR.
Northern Blot (Northern blotting): Evaluating the presence and size of the target RNA through the signal intensity of RNA membrane imprinting. It has now largely been replaced by RT-qPCR.
How do you remove host cell RNA?
-
1) RNAase elimination;
2) Q-column purification to remove nucleic acids.
What is the most accurate method for RNA quantification?
-
Real-time PCR is the mainstream method and also the method recognized by the pharmacopoeia; digital PCR (dPCR) is a new method, with higher costs and not widely used on a large scale.
Why use this assay kit?
-
Given that the FDA in the United States, the EMA in Europe, and the NMPA in China all require clear detection requirements for impurities from cell sources, including impurities such as RNA, this kit uses the Real time-PCR method to quantitatively determine the residual level of RNA in the drug.
