project background
Sf Elastovirus Detection Kit
Insect cell lines (Sf) isolated from female Noctuid pupae are widely used as hosts for recombinant protein production in baculovirus-insect cell systems (BICS). However, the discovery of a new elastovirus (SF-RV) in the Sf cell line has raised concerns about the safety of biologics produced by BICS.
The 2020 edition of the Chinese Pharmacopoeia has added a new chapter on "Virus Safety Control of Biological Products", emphasizing the potential risk of virus contamination during the production process of biological products and proposing comprehensive risk assessment and control measures, including source control of raw materials, virus contamination screening during the production process, validation of specific virus removal processes, and detection of virus contamination in products. According to the "General Principles for Technical Review of Viral Safety Evaluation of Biological Tissue Extract Products and Eukaryotic Cell Expression Products" issued by the Center for Drug Evaluation of China, biological products expressed from animal-derived cells must undergo endogenous and exogenous virus detection, and the virus inactivation/removal process needs to be verified. Iso 224422-1 states that animal-derived medical devices need to control exogenous viruses.
The detection of Sf elastovirus during the production process is an important means to control the viral safety risks of biological products and ensure production quality.
Zhuhai Baorui Biotechnology Co., Ltd. has launched the Sf elastovirus Detection Kit (PCR-fluorescence probe method), which is perfectly matched with the nucleic acid extraction/purification Kit I (magnetic bead method), providing a rapid and convenient Sf elastovirus detection solution for laboratories and production lines。
Sf Elastovirus Detection Kit
The detection limit reaches 0.5copies/μL.
The structural analogues and commonly used cell lines of 27 types of Sf springvirus were verified, and none of them had cross-reactions with the Sf springvirus detection reagent.
Convenient and fast operation
The one-step RT-qPCR reagent allows the extracted nucleic acid to be directly added to the premixed PCR reaction solution without the need for reverse transcription in advance, thus reducing the operation steps.
2. The detection is highly efficient, taking only 2 hours throughout the process, from sample extraction to result release.
Extensively verify multiple sample types to ensure that the detection sensitivity is not affected by the matrix.
1. The test reagents contain internal quality control (IC) and positive quality control (PC), effectively avoiding false negatives and fakesThe occurrence of positive results;
2. The UDG enzyme anti-contamination system is adopted to avoid contamination risks.
1. Freeze-thaw stability
The kit was repeatedly frozen and thawed 3, 5, 7 and 10 times. The test results of the samples within the detection limit were positive, and the precision CV of the Ct value of the median samples was ≤5%, indicating that the kit had good stability within 10 freeze-thaw cycles.
2. Instrument applicability
It can be normally detected on various models of devices such as ABI7500, ABlQuantStudio™5, Bio-RAD CFX96, SLAN-96P, SLAN-96S, and Roche Lightcycler480Ⅱ.
References
1. Chinese Pharmacopoeia, 2020 Edition, Part III - Preparation and Quality Control of Animal Cell Matrix for the Production and Testing of Biological Products.
2. Chinese Pharmacopoeia, 2020 Edition, Part III - Safety Control of Viruses in Biological Products.
3. General Principles for Technical Review of Viral Safety Evaluation of Biological Tissue Extract Products and Eukaryotic Cell Expression Products
4. European Pharmacopoeia EP10
5. Japanese Pharmacopoeia (17th Edition, JP).
