From Design to Production, MRIGlobal's Expertise Enhances Safe and Effective Drug Development
MRIGlobal's scientists fill a critical need in designing and evaluating human and animal drugs and vaccines, from initial formulation to safety and efficacy analysis, and at every step of the way through complex federal regulatory processes.
Production methodology, drug shelf-life determinations, and quality assurance are examples of the breadth of MRIGlobal’s expertise in pharmaceutical product development.
Services encompass in vitro and in vivo testing, diverse routes of drug delivery, and studies of absorption, distribution, metabolism, and excretion (ADME) using radiolabeled and nonlabeled molecules.
Our Capabilities:
- Pharmacokinetics and drug metabolism data analyses, including measures of accuracy, linearity, ruggedness, precision, specificity, and sensitivity
- Chemical characterization of new drug substances and formulations, including determining impurities and toxicology studies
Drug safety evaluations- Assays for stability data on bulk drug and formulated products
- Advanced analytical instrumentation and facilities for mass spectrometry, chromatography, titrations, and physical and chemical property measurements
- Nutraceutical and natural botanical product expertise
- Stringent quality assurance under Good Laboratory Practice (GLP) regulations
MRIGlobal’s Pharmaceutical Product Development Successes:
- Chemical Carcinogen Reference Standards Repository: MRIGlobal operates a repository that supplies standard reference-grade compounds for cancer research for the National Cancer Institute.
- Custom Synthesis and Radiochemical Synthesis: MRIGlobal specializes in comprehensive carbon-14 and tritium synthesis of radiolabeled, mass labeled, and nonlabeled compounds. MRIGlobal delivers target molecules for pharmacokinetic and agrichemical product requirements, including products under evaluation as cancer-preventing agents.
Transformational Medical Technologies Initiative: MRIGlobal works to accelerate the discovery and development of broad-spectrum countermeasures to address emerging, genetically engineered and unknown biothreat agents.
- Biomedical Advanced Research and Development Authority: MRIGlobal supports this agency of the U.S. Department of Health and Human Services in its mission to develop medical countermeasures for pandemic influenza and other emerging infectious diseases.