H. pylori - Ace Infectious
Drug Resistance Assessment and Anti-drug Antibody Testing
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Drug Resistance Assessment and Anti-drug Antibody Testing

Ace Infectious provides comprehensive support for the testing and analysis of H. pylori drugs. To better evaluate the potential application of H. pylori drugs in clinical, we offer resistance assessment for small molecule drugs and anti-drug antibody (ADA) testing for H. pylori therapeutic peptides and proteins. We pay attention to various interfering factors in ADA testing, such as drug target interference.

Fig. 1 Interference of drug target in a bridging ADA assay (Zhong et al., 2017).Fig. 1 Interference of drug target in a bridging ADA assay (Zhong et al., 2017).

Assessment of drug resistance of H. pylori small molecule drugs

The issue of drug resistance in H. pylori has been an important concern in H. pylori drug development. An optimal new drug for the treatment of H. pylori needs to be able to treat existing drug-resistant strains of H. pylori.

Two important causes of drug resistance in H. pylori are genetic mutations and drug efflux by the efflux pump. For drug resistance due to genetic mutations, we have a wide range of H. pylori drug-resistant strains that can be evaluated for this type of resistance. First, we offer a comprehensive resistance assessment of multiple drug-resistant strains. In addition, we provide the specific resistance assessment depending on the specific resistance assessment needs of our clients. For example, we offer drug resistance testing based on infB and rpl22 mutation resistant strains, gyrA mutation resistant strains, and 16S rRNA gene or 23S rRNA gene mutation resistant strains. For drug resistance due to efflux pumps, we offer experiments using common H. pylori strains and test for changes in environmental drug levels under the action of specific efflux pump inhibitors.

Particularly, we also offer an induced resistance assessment to determine the risk of drug resistance after long-term action of the drug on H. pylori.

ADA testing of H. pylori therapeutic proteins and peptides

Immunogenicity assessment is necessary for therapeutic protein drugs. One important test is the detection of anti-drug antibodies (ADAs). For drugs that mimic H. pylori adhesins, there is an even greater need for ADA testing.

We offer ADA testing in three parts, ADA screening, ADA confirmatory, and ADA characterization. In the screening process, we make it our priority to exclude false negatives. In confirmatory, we take immunoprecipitation, bridged method, immunodepletion, and others for confirmatory. Prior to the characterization assay, we perform immunostimulation using multiplex immunization methods with a small number of drugs to better characterize ADAs. In addition, we test numbers of data in conjunction with PK studies, including the incidence of ADAs, titer, duration of persistence, and neutralization capacity. If there is a need for neutralizing antibody assays, we are pleased to provide that too.

We have accumulated extensive experience in ADA testing, and we also provide ADA testing in our H. pylori vaccine development services.

Contact us

Ace Infectious considers all aspects of H. pylori drug development needs. We provide valuable services in the detection and evaluation of H. pylori drugs based on the specific needs of H. pylori drugs. In addition to drug resistance assessment and ADA testing, we also provide immunogenicity testing, pharmacological economy assessment, and comparative evaluation services. Our goal is to be a one-stop-shop for H. pylori research, so you can contact us for any H. pylori-related needs.

References

  1. Zanotti, G.; Cendron, L. Structural aspects of Helicobacter pylori antibiotic resistance. Helicobacter pylori in Human Diseases. 2019, 1149: 227-41.
  2. Jani, D.; et al. Recommendations for the development and validation of confirmatory anti-drug antibody assays. Bioanalysis. 2015, 7(13): 1619-31.
  3. Zhong, Z. D.; et al. Drug target interference in immunogenicity assays: Recommendations and mitigation strategies. The AAPS Journal. 2017, 19(6): 1564-75.

※ All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.