Custom Microbiology Assay Development Services
Well-designed Reliable microbial assays are crucial for drug and biologics development. As essential quality control tests, they ensure safety, efficacy, and sterility by detecting microbial contaminants. These assays guide formulation, manufacturing, and regulatory compliance, and help identify antimicrobial properties in new drugs. Advanced microbial assay techniques accelerate drug development and improve product reliability, enhancing patient outcomes.
Our Expertise
Our team of scientists have expertise in creating custom microbiology assays tailored to meet the unique needs of your research and development projects as well as to support therapeutic manufacturing. We combine scientific excellence with cutting-edge technology to deliver accurate, reproducible, and timely results.
Our Services
Custom Microbiological Assay Development
Application
Description
Rec– Genotype
E coli strains which are defective in their DNA repair mechanism (rec–) are differentiated from wild type cells by testing their sensitivity towards UV irradiation.
Lac– Genotype
Bacteria unable to utilize lactose as a carbon source (lac–) are differentiated from lac+ cells by plating on differential agar media.
Bacterial Detection Assays
Customized assays for the detection and quantification of bacteria tailored to your specific research needs.
Microbial Sensitivity/Selection Testing
Development of protocols to assess the efficacy of antimicrobial agents or antibiotic selection.
Microbial Identification Assays
Incorporation of specific identification techniques and biochemical testing to accurately classify microorganisms.
16S Sequencing
Amplify 16S target sequences from bacterial strains followed by Sanger sequencing for bacterial identification.
Assay Optimization
Application
Description
Enhanced Efficiency
Tailor existing protocols to improve accuracy, sensitivity, and specificity of detection.
Optimize Methodologies
Modify lengthy expansion steps and culture conditions to optimize assay performance.
Assay Validation Services
Application
Description
Comprehensive Validation
Incorporate ICH/FDA analytical testing methodologies to ensure adequate validation for use in testing applications requiring regulated oversight.
Summary Report
All procedures, raw data and validation results provided in a detailed summary report.
Ongoing Support
Provide continuous testing support to ensure the success and reliability of your microbiology assays.