Nova Biologicals contracted with a global specialty chemicals company with leading positions in the fast-growing bacteria GMO industrial markets. Nova Biologicals successfully developed a cGLP process to solve requirement to evaluate antimicrobial susceptibility of several genetically modified Pseudomonas species bacteria.
Nova Biologicals contracted with a global specialty chemicals company with leading positions in the fast-growing bacteria GMO (genetically modified organisms) industrial markets. Bacteria GMOs are used in the manufacturing of pharmaceuticals, biologically active agents and other chemical agents. Regulatory authorities required the client to evaluate the antimicrobial susceptibility of several of their genetically modified Pseudomonas species bacteria. Fourteen different US Pharmacopeia reference antimicrobials were used to determine the respective minimum inhibitory concentrations (MICs) of each bacterium.
Conducting triplicate cGLP (Current Good Laboratory Practices) MIC testing of several strains of genetically modified Pseudomonas fluorescens. MIC testing was conducted according to CLIS Guideline M07-A9: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition and in accordance with U.S. Code of Federal Regulations (21 CFR: Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies)
Execution of cGLP-compliant plan for the preparation and testing of antimicrobial dilutions and standardized bacterial suspensions used to conduct microtiter-plate testing. A comprehensive set of worksheets and logs were compiled to form the full data package.
cGLP report submitted and accepted by client. Regulatory authorities accepted cGLP report. Test results supported the commercial considerations associated with client’s GMO program. Testing met client’s expectations.
Due to the complexity of the overall project, the initial planning process proved to be a key factor in the project success. This planning included Nova Biologicals personnel and the client’s quality assurance, regulatory compliance and technical staff. It also answered many of the concerns and questions of each project participant; thereby improving communication and confidence in the project’s outcome.
Apply the cGLP process developed for this project to other bacteria included in the client’s GMO program.