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PHARMout Laboratories, Inc.

PHARMout Laboratories, allied with Biokey ( http://www.biokeyinc.com ), specializes in comprehensive DMPK screening, efficacy/toxicity assessment, analytical and bioanalytical services. We utilize advanced analytical technologies including LC-MS/MS and ELISA for quantitative and qualitative analyses of small molecules, antibodies, proteins, and nucleic acids. We are committed to providing the highest level of services, compliances and supports to our clients.

About Us

PHARMout is a Contract Research Organization (CRO) providing a wide range of services, including:

•DMPK Screening, in vitro and in vivo (Rodents/Non-Rodents/Primates)

•GLP Bioanalysis and GMP Analysis: Method Development/Validation

•Efficacy/Toxicity Assessment

•Identification of Metabolites, Degradants, and Impurities

•API/Drug Product Stability and Dissolution Testing

•Characterization of Antibodies, ADCs, Peptides, and Proteins

We are an FDA compliant GLP facility licensed for DEA substances. Our instrumentation includes state-of-the-art AB Sciex triple quadrupole mass spectrometers and Perkin Elmer Immunoassay Plate reader. We have an established infrastructure that includes SOPs, QA, and Archivist.

The advantages of partnering with Biokey are reflected in our total Commitment to Quality, Timely and Flexible services

Services

ANALYTICAL SERVICES

Analytical R&D, method development, and method validation.

Develop HPLC analytical assay methods
Conduct forced degradation studies to determine degradants and impurity profile
Characterization and identification impurities
Develop stability indicating methods
Develop and perform the dissolution profile studies for immediate and modified release
Develop and validate cleaning validation methods using HPLC
Perform material testing according to USP or customer's specifications
Characterization of polymers using size exclusion chromatography

BIOANALYTICAL SERVICES

Services for discovery Non-GLP bioanalysis and DMPK screening and development GLP bioanalysis.

LC/MS/MS Bioanalysis, GLP and Non-GLP, for plasma/blood/tissue/ urine/dried blood spot samples using AB Sciex instrument
Method development and validation
Microsomal, S9, and plasma stability
Plasma protein binding
Metabolite profile and identification, in vitro and in vivo
ELISA for biomarker and antibody/ protein analysis using Perkin Elmer/ Wallac Victor3 1420-015 Multilabel Counter

DMPK SCREENING SERVICES

We provide comprehensive in vitro and in vivo DMPK screening.

•In vitro (liver microsomes/S9/hepatocytes) and in vivo (rodents/non-rodents/primates) metabolite profiling and identification

•Microsomal/S9/hepatocyte/plasma/intestine fluid stability characterization

•Plasma protein binding (RED/HTD) and blood/plasma ratio determination

•Expedited discovery screening

PRECLINICAL SERVICES

Preclinical services are available for rodents, non-rodents, and primates.

•In vivo ADME: PK, tissue distribution, metabolism/excretion, and CSF penetration

•Efficacy assays/models, and exploratory toxicity studies

•IND-enabling DMPK package study

GMP AND GLP COMPLIANT

PHARMout Laboratories is a GMP and GLP-compliant CRO specializing in quantitative and qualitative method development, validation and analysis.

FACILITY

Advanced laboratory facilities include mass spectrometers and other specialized equipment in support of your needs for rapid turnaround times, quality, technical excellence and cost savings.