Pharmaceutical Testing

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.

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.

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).