Combating antibiotic resistant bacteria is tantamount to the future quality of patient care on a global basis.
Superbugs with multidrug resistance (MDR) are increasingly wide spread in both hospital acquired infections (HAI’s) and public health outbreaks. MRSA, VRE & C. diff are just a few types that strike fear in the general population. With recent legislation, such as the PATH ACT and HHS initiatives like CARB-X, new antibiotic development is being accelerated.
Microbiology Research Associates (MRA) has assisted in recent new antibiotic development projects specifically designed to combat these organisms for various Biopharma clients. In our role, we have provided microbial technical expertise to support efficacy testing primarily targeting susceptibility testing, sample characterization and method validation.
Our antibiotic experience has been with:
- Short chain amino acids (aka defense mimetics)
- Extended Spectrum beta-lactamase inhibitors (ESBL)
- Daptomycin Derivatives
- Lipopeptides inhibitors
- Combination Products
These cutting edge technologies for combating antibiotic resistant bacteria (CARB) are difficult to achieve with microbiology testing which are dependent on recovery specifications to verify test method validation.
MRA has successfully accomplished this and has established compliant USP compendial testing for the following regulatory specialties:
- <51> Antimicrobial Effectiveness Testing
- <61> Microbial Examination of Nonsterile Products (Microbial Enumeration Test)
- <62> Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms
- <71> Sterility Testing
- <85> Bacterial Endotoxin Testing
The aforementioned methods combined with Kirby Bauer disk diffusion and minimum inhibitory concentration (MIC) analysis provide verification and validation of susceptibility and lethality. In this way, MRA demonstrates the new antibiotic effectiveness and overall product quality which is a major acceptance criteria for regulatory compliance.
Please let us know if MRA can be a partner in your new antibiotic development program.