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Antibiotic and Antibacterial Vaccine Development Services 06/01/18 Antibiotic and Antibacterial Vaccine Development Services www.SouthernResearch.org/Drug-Development Contents Why choose Southern Research? ................................................................................................................. 4 in vitro Testing Services................................................................................................................................ 5 B0101 Minimum Inhibitory Concentration (MIC): ........................................................................................ 5 B0102 Minimum Bactericidal Concentration (MBC): .................................................................................... 5 B0103 Time-kill Assay: .................................................................................................................................. 5 B0104 Resistance Frequency Determination: ............................................................................................... 5 B0105 Post-antibiotic Effect (PAE): ............................................................................................................... 6 B0106 Serum and B0107 Protein Sensitivity: ............................................................................................... 6 B0108 Serum and B0109 Protein Binding: .................................................................................................... 6 B0110 Plasma and B0111 Microsome Stability: ........................................................................................... 6 B0112 Synergy Testing: ................................................................................................................................. 7 B0113 Minimum Biofilm Inhibition Concentration (MBIC): .......................................................................... 7 B0114 Minimum Biofilm Eradication Concentration (MBEC): ...................................................................... 7 B0115 Minimum Inhibitory Concentration 90% (MIC 90): ............................................................................. 8 B0116 Opsonophagocytic Killing Assay (OPKA): ........................................................................................... 8 B0117 Opsonophagocytic Uptake Assay (OPUA): ......................................................................................... 8 B0118 Serum Bactericidal Activity (SBA): ..................................................................................................... 8 in vivo Testing ............................................................................................................................................... 9 B0201 Maximum tolerated dose (MTD): ...................................................................................................... 9 B0202 Dose Range Finding (DRF): ................................................................................................................. 9 B0203 Pharmacokinetic Profiling (PK): ......................................................................................................... 9 B0204 Bioavailability: .................................................................................................................................... 9 B0205 Neutropenic Mouse Thigh (NMTh): ................................................................................................. 10 B0206 Neutropenic Mouse Lung (NMLu): .................................................................................................. 10 B0207 Acute Murine Sepsis/Peritonitis: ..................................................................................................... 10 B0208 Chronic Murine Sepsis (Cecal Ligation and Puncture): .................................................................... 10 B0209 Murine Acute Pneumonia: ............................................................................................................... 11 B0210 Skin Infection – Tape-stripping: ....................................................................................................... 11 B0211 Surgical Site Infection—Suture: ....................................................................................................... 11 www.SouthernResearch.org/Drug-Development B0212 Wound Infection—Punch Biopsy: .................................................................................................... 11 B0213 Transcervical Chlamydia Persistence: .............................................................................................. 12 B0214 Pharmacodynamic Dose Fractionation: ........................................................................................... 12 B0215 in vivo Resistance Monitoring: ......................................................................................................... 12 B0216 in vivo Post-Antibiotic Effect (PAE): ................................................................................................. 12 B0217 Vaccine Immunogenicity Evaluation: ............................................................................................... 13 IND-Enabling Toxicology: ............................................................................................................................ 13 Clinical Trial Endpoint Analysis .................................................................................................................. 14 B0301 Opsonophagocytic Killing Assay (OPKA): ......................................................................................... 14 B0302 Opsonophagocytic Uptake Assay (OPUA): ...................................................................................... 14 B0303 Serum Bactericidal Activity (SBA): ................................................................................................... 14 Additional Bioanalytical and Immunological Endpoint Assays: .................................................................. 14 www.SouthernResearch.org/Drug-Development Southern Research Why choose Southern Research? Founded in 1941 in Birmingham, Alabama, Southern Research is a scientific and engineering contract research organization that conducts drug discovery and development, environmental and occupational hazard characterization, advanced engineering research in materials and systems development, and energy and environmental technologies research. SR supports clients and partners in the pharmaceutical, agrochemical, biotechnology, defense, aerospace, environmental, and energy industries. We deliver quality results and a quality experience. That means we’re rapid, reliable, and responsive. With over 50 years of experience, we recognized that no two test articles are ever the same. That’s why our approach has always been, and still is, to focus on each client’s individual needs. Our scientists and study directors will take the time to understand your program and the specific risks and liabilities you are concerned about. Then, after we fully understand your needs, we will work with you to develop the most appropriate, regulatory-compliant testing plan. But the quality experience doesn’t stop when the study protocol is signed. Our nationally recognized scientific and quality assurance teams will execute the plan to our exacting operational standards, ensuring we generate the highest quality data and reports. Throughout the study, be it one day or two years, your Southern Research study director will be readily accessible and will proactively communicate the status of your project. Services What our clients are saying . In vitro antibacterial, antiviral and anticancer screening . “Everything has been excellent. Communication between . Infectious disease and cancer animal efficacy models my company and the SR group has been great. They have been very responsive and have expertly solved all issues . Pharmacokinetics/Toxicokinetics we’ve encountered. The SR group has performed . Immunoassay and bioanalytical chemistry exceptionally well! We hope to work with them again.” . Immunogenicity and immunopotency . “I’m very impressed with the SR study director. He is very . Vaccine neurovirulence/neuropathology responsive and thoughtful. I very much enjoy working with . IND-enabling nonclinical toxicology him.” . Developmental and reproductive toxicology “Thanks for all of your efforts. The study, although very challenging, really went a long way towards us obtaining . Neurotoxicity and neurobehavioral assessment clearance to commence our Phase I trial.” . Clinical trial endpoint analysis Experience The SR campus in downtown Birmingham, Alabama. Internationally recognized infectious disease, cancer, immunoassay, and bioanalytical chemistry experts . Multiple American Board of Toxicology certified toxicologists . Multiple American College of Veterinary Pathologists certified pathologists . Multi-award winning histopathology support team . American Association for Laboratory Animal Science (AALAS) accredited technicians and managers . Nationally recognized quality assurance unit . Compliance with federal and industry regulations (ICH, OECD, EPA, FDA, USDA, OLAW, GLP) www.SouthernResearch.org/Drug-Development Southern Research | in vitro Services in vitro Testing Services B0101 Minimum Inhibitory Concentration (MIC): The MIC is defined as the lowest concentration of compound needed to inhibit visible growth for a given organism. It is determined following Clinical and Laboratory Standards Institute (CLSI) guidelines, as appropriate. The MIC is reported as the
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