The potential viral contamination of commonly used starting materials, raw materials or excipients in the production of biological products is a key factor affecting the safety of the products. Bovine origin materials such as newborn bovine serum and trypsin are widely used in the production process of biological products. The detection of bovine viruses during the production process is an important means to control the viral safety risks of biological products and ensure production quality.
Regulatory requirements
According to the third part of the 2020 edition of the Chinese Pharmacopoeia, virus screening should be conducted on the relevant materials (starting materials, raw materials and excipients) used in the production process of biological products, the virus clearance effect in the production process should be verified, and virus contamination of products (intermediate products and finished products) should be detected.
If the producer used bovine serum in the establishment or passage history of the cell matrix before building the bank, the MCB or WCB and/or production terminal cells established by it shall be tested for bovine virus at least once in accordance with the requirements of General Chapter 3604.Foreign regulations such as the United States Pharmacopeia and the European Pharmacopoeia also have similar requirements for the detection of bovine viruses.
Zhuhai Baorui Biotechnology Co., Ltd. has developed a bovine virus nucleic acid detection kit (PCR-fluorescence probe method) in accordance with the relevant requirements of the Chinese Pharmacopoeia. It can be used in conjunction with Zhuhai Baorui Biotechnology Co., LTD. 's nucleic acid extraction or purification Kit I (magnetic bead method), enabling simultaneous detection of multiple targets in a single tube. After comprehensive performance verification, it has high sensitivity. It has strong specificity, good stability and is easy to use.
Product advantages
01
High sensitivity
The detection limit reached 1 copy/μL. Five bovine virus nucleic acids were verified, and 24 tests were conducted respectively. The detection ratio could all reach above 23/24. The results are shown in Table 1
Table 1: Summary of Detection Limit Data for 5 Bovine Viruses
02
Strong specificity
Twenty-seven genomic Dnas were verified (LC-MK-2, CHO, HEK293, BHK21, SP2/0, Escherichia coli, PK-15, NS0, Vero, Sf9, MDCK, MDBK, C6, hybridoma cells, CRFK, Pichia pastoris, Mycobacterium smegma, LC-MK-3, intermediate glucose bacteria) There is no cross-reaction between the nucleic acid detection reagents for bovine viruses such as β -Staphylococcus aureus, Lactobacillus acidophilus, Staphylococcus epidermidis, Harzburg, Propionibacterium, bovine Lactobacillus acidophilus, Aspergillus red, Pseudomonas aeruginosa, etc.
03
Convenient and fast operation
The kit contains positive controls of the corresponding sequences of the five viruses to be tested, which is convenient for monitoring the test results and does not require additional purchase.
2. The RNA reaction system and the DNA reaction system use the same amplification procedure, reducing operation steps and improving the efficiency of instrument utilization.
From sample extraction to the completion of the test, it takes less than 2 hours.
04
Strong applicability
A variety of matrix samples and multiple PCR amplification systems were verified, and the performance of the kit was not affected.
05
The system is reliable
1.It includes internal quality control (IC) and positive quality control (PC), effectively preventing the occurrence of false negative and false positive results。
2.The UDG enzyme anti-contamination system is adopted to avoid contamination risks.
06
Interference assessment
It was verified that eight matrix samples (RPMI1640, SP2/0 culture medium, 10%FBS, 10% premium fetal bovine serum, 100% premium fetal bovine serum, DNA diluents, bacterial culture medium, PBS, etc.) had no interference with the nucleic acid detection reagents for bovine viruses。
07
Durability
1. Freeze-thaw stabilityThe 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 median sample precision CV was ≤5%, indicating that the kit had good stability within 10 freeze-thaw cycles。
2. PrecisionTo test the precision among different operators and different instruments, 10 replicates were conducted for high, medium and low value samples respectively, and the CV% was all less than 5%。
3. Instrument ApplicabilityThe performance is not affected on different models of equipment such as ABI 7500, Bio-Rad CFX96, SLAN-96P, SLAN-96S, Roche Light cycler 480 Ⅱ, and Borui FQD-96A.
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 3 -3604 Newborn Bovine Serum.
3. European Pharmacopoeia.
4. Japanese Pharmacopoeia (17th Edition, JP).
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