Pharmaceutical Testing
Every year the pharmaceutical industry introduces new medications to the world. It’s essential that these pharmaceutical products are safe for consumer health.
At Nova Biologicals, our team works diligently to improve public health by testing the safety and effectiveness of compound pharmaceuticals through a rigorous set of microbial testing services.
Lowering Pharmaceutical Costs
In addition to testing, we are exploring ways to lower the costs associated with the production and development of pharmaceutical drugs. Our Current Good Laboratory Practices (GLP) compliance program is helping to make the process more cost-effective. The program also provides our team with a qualified approach to understanding pharmaceutical microbiological testing.
USP Testing of Excipients
Nova also specializes in the USP testing of excipients. These substances, which are found in practically all marketed drugs in both natural and synthetic forms, are used to bulk up formulations or aid in drug absorption. Thousands of different excipients are used in various medicines and, on average, account for about 90% of each product. They are considered pharmacologically inert but can still interact with active ingredients or other excipients. We test the safety of these excipients to verify that they are regulatory compliant and meet quality standards.
Types of Tests
Methicillin-Resistant Staphylococcus Aureus (MRSA) Testing Services
- GLP Studies
- Minimal Inhibitory Concentration, MIC
- Minimum Bactericidal Concentration, MBC
- Disinfectant Efficacy Testing
- Use Dilution Testing
- AOAC Testing
Microbiological Examination of Nutritional and Dietary Supplements
Nova Biologicals provides microbiological testing of nutritional and dietary supplements (USP <2021>, <2022>, ) for the pharmaceutical industry.
Minimal Inhibitory Concentration (Mic)
Minimal Inhibitory Concentration (MIC) is one of the many antimicrobial and disinfectant testing services offered by Nova Biologicals, Inc.
The Minimal Inhibitory Concentration (MIC) of each selected antibiotic/antimicrobial is determined by utilizing serial dilutions of the antibiotic/antimicrobial which has been inoculated with the organisms listed above and incubated. The minimal inhibitory concentration (MIC) is the lowest concentration without apparent growth.
MIC determinations are conducted according to M07-A9 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Eighth Edition & Performance Standards for Antimicrobial Susceptibility Testing and M11-A8 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Anaerobically; Approved Standard – Seventh Edition. Clinical Laboratory Standards Institute (formerly NCCLS).
The Minimum Bactericidal Concentration (MBC) is determined using microtiter plate well of antibiotic inoculated with a known concentration of the isolated infecting organism. After overnight incubation and subsequent quantitative subculture of the non-turbid wells, the concentration of drug that produces a 99.9% reduction in the starting inoculum determines the MBC.
MBC determinations are conducted according to M07-A6 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Sixth Edition. Clinical Laboratory Standards Institute (formerly NCCLS).