Central Laboratories Capabilities Featured Methods

Flow Cytometry

Medpace has an experienced flow cytometry team overseen by PhD-level scientists with over 10 years of experience designing, analyzing, and interpreting multicolor flow cytometry assays. Whether a custom panel needs to be developed or a method needs to be transferred to our laboratory to support a global clinical trial, we have the experience to quickly validate and implement the flow cytometry testing.

Medpace has global flow cytometry capabilities at the US, Belgium, and Singapore laboratories.

Central Lab Services

Cell Enumeration	PBMC (Peripheral Blood Mononuclear Cells)
Custom Panel Validations	Receptor Saturation Assays
Immune Response	T-Reg Assays
Intracellular Cytokine Expression	TBNK Panel (T Cells, B Cells, Natural Killer Cells)

Key Instrumentation

BD FACSCanto™ – 10 Color

Medpace has a strategic lab partnership that has extensive experience performing flow cytometry hematomalignancies, LAIP (leukemia-associated immunophenotypes), and MRD (minimal residual disease) analysis requiring a pathologist review and interpretation.

Preparative Ultracentrifugation (PUC)

Preparative ultracentrifugation (PUC) is the gold standard method for lipoprotein fractionation. Medpace labs is the “go-to” lab for PUC analysis for drugs in development, with capability for this very specialized and technically difficult testing in all four Medpace global central lab locations for low-density lipoprotein and other lipoprotein classes. Medpace performs PUC in high volume with over 2,000 analyses monthly.

PUC testing isolates the following lipoproteins, allowing the quantification of cholesterol, triglycerides, apolipoproteins (AI, AII, AIV, B48, B100, CII, CIII, E), phospholipids, fatty acids, and other lipid specific analytes.

Lipoprotein Fractions Isolated

Chylomicron Fraction	LDL(Low Density Lipoprotein) Fraction
VLDL (Very Low Density Lipoprotein) Fraction	HDL (High Density Lipoprotein) Fraction
IDL (Intermediate Density Lipoprotein) Fraction	HDL Sub-fractions HDL2 and HDL3

PUC Scientific Posters Presented by Medpace

Friedewald Formula Significantly Underestimates LDL Cholesterol Compared to Preparative Ultracentrifugation below 70 mg/dL leading to Overestimation of the LDL Cholesterol Reduction for New drugs in Development

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Accurate Assessment of LDL Cholesterol Reduction at Levels Below 70mg/dL Has Implications in the Estimation of Efficacy for New Drugs in Development

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Underestimation of LDL Cholesterol Below 70 mg/dL (1.8 mmol/L) by Friedewald, Hopkins and a “Direct” Assay Compared to Preparative Ultracentrifugation Leading to the Overestimation of LDL Cholesterol Reduction for New Drugs in Development

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LDL Cholesterol Reduction with BMS-962476, An Adnectin Inhibitor Of PCSK9: Results Of A Single Ascending Dose Study

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Genomics and Molecular Assays

Testing a subject for specific genomic biomarkers can provide insight into risks for various disease states or predict response to specific treatment approaches, and enable clinicians to provide personalized treatment. Pharmacogenomics (PGx) examines the genetic differences in drug metabolic pathways which can affect a subject’s response to therapeutics.

Central Lab Services	Key Instrumentation
DNA Extractions (Concentration, Purity, Yield)	Abbott Molecular m2000
RNA Extraction (Concentration, Integrity, Yield)	Agilent Bioanalyzer
Next-Gen Sequencing	Illumina MiSeqDx
Companion Diagnostics	Sponsor specific instrumentation installed for CDx studies
Viral Load Testing, including:
Hepatitis B Virus DNA
Hepatitis C Virus RNA Qualitative/Quantitative

Medpace has a network of reference and strategic laboratory partners with extensive experience in genomic testing that provide seamless service to our clients.

Genomic and Molecular Testing

Allele-specific PCR	Microarray
Capillary Gel Electrophoresis	MRD by qPCR or NGS
Cytogenetics	Next-Gen Sequencing (MiSeqDx, Ion Torrent)
dPCR	PGx and Companion Diagnostics
Gene expression and allelic load by real-time PCR	Sanger Sequencing

Chromatography

Medpace laboratories (central and bioanalytical labs) have broad experience in chromatographic assays supporting preclinical studies and Phase I-IV clinical trials.

Laboratory Services		Key Instrumentation
Bile Acids	Nutritional Biomarkers, including	AB Sciex 4000, 5500, 5600, and 6500 LC-MS/MS
Drug pharmacokinetics and metabolite profiling	Alpha Carotene	Shimadzu 060 LC-MS/MS
Fatty Acid Panel	Beta Carotene	Shimadzu GCMS-QP2010
Hemoglobin A1c (NGSP Level 1 accredited)	Vitamin A	Tosoh G7
Retinyl Palmitate	Vitamin B	Tosoh G8
Hormones, including:	Vitamin 25 OH D2and D3	Waters AcQuity UPLC
Dihydrotestosterone (DHT)	Vitamin E	Waters Xevo TQ-XS LC-MS/MS
Estradiol/Estrone	Vitamin K1 and K2
Testosterone Total / Free