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Covid-19
One-stop Central Lab Services
Rich Covid-19 project management and laboratory service experience helps sponsors to integrate global network and accelerate the study
Due to the raging epidemic, Covid-19 vaccine has become a hot track for clinical trials of new drugs seeing related demand risen sharply. Teddylab reserves a series of related test technologies through independent research and development to monitor the efficacy, immunogenicity, PK/PD data and genotyping of virus strains during Covid-19 vaccine clinical trials.
Pseudovirus testing is an important method for replacing virulent viruses that must be studied in a biosafety level 3 (BSL3) or higher (BSL4) laboratory. With the spread of the virus worldwide, it is critical to establish a SARS-CoV-2 pseudovirus neutralization test method that can be used in the biosafety secondary laboratory (BSL2) for the monitoring and prevention of SARS-CoV-2. At present, Teddylab has established anti-SARS-CoV-2 wild-type strains, as well as Delta, Omicron BA.1, Omicron BA.2, Omicron BA.4 and Omicron BA.5. Pseudovirus-neutralizing antibody assays for these mutant strains have become powerful tools for evaluating vaccine protection and efficacy in clinical trials.
There is a high correlation between the immunogenicity induced by the Covid-19 vaccine and its protective effect, which includes humoral immunity and cellular immunity. In the clinical phase I/II/III trials of the vaccine, the neutralizing antibody level is used as an important basis for its protective effect. Therefore, the establishment of a highly reliable immunogenicity test technology is critical in the process of vaccine development. With frequent mutations of the virus, development speed of traditional inactivated and recombinant vaccines has become a bottleneck that hinders the marketing of vaccines, while mRNA technology can speed it up. There are several mRNA monovalent and polyvalent vaccines that are currently in the clinical development process. In order to meet the needs of clinical trials of Covid-19 vaccines, Teddylab has rapidly established a complete set of methodologies and technical platforms for vaccine immunogenicity evaluation through independent research and development, and has provided clinical sample test services for domestic vaccine development pharmaceutical companies, including specific IgG test, neutralizing antibody test, specific T cell test, viral load test and other technologies. This technology platform is also applicable to other mRNA gene therapy products, which can empower the clinical trials of mRNA products of domestic companies.
Viral load test is usually used to judge the changing trend of the virus, and it is an important efficacy indicator of viral therapeutic drugs. There is a lack of mature viral load test schemes in China for Covid-19. By designing specific primer probes on different specific genes ORF1ab, N, E, spiked national standard in the qPCR reaction system, and calculating the viral load of the test sample according to the standard curve, Teddylab realized virus load test for different sample types. Relevant test technologies are widely used in the clinical trials of coronavirus-related small molecule therapeutic drugs, neutralizing antibodies and vaccines.
In order to deal with the frequent genetic mutations of coronavirus, clinical trials need to first stratify the virus mutation types of infected patients, and then evaluate the vaccine protection efficiency and drug efficacy. Based on NGS second-generation gene sequencing technology, Teddylab uses the method of sequencing the whole genome of the virus to obtain the base sequence information of its RNA, covering ORF1~12, N, E, S genes, and through the biological information analysis method Identification of SARS-CoV-2 wild-type strains, as well as different viruses such as Delta, Omicron BA.1, Omicron BA.2, Omicron BA.4, and Omicron BA.5 type of mutation. Identifying the variant can help with in-depth research on the pathogenic mechanism of the virus, virus tracing and epidemiological investigation, and the study of antiviral treatment efficacy vaccines and antiviral drugs on different types of mutant strains. Distinguishment of the decline in efficacy of vaccines or treatments due to virus mutation is helpful for vaccine development and adjustment and optimization of existing treatment regimens.
