Molecular Testing

The Gempharmatech molecular testing laboratory is equipped with a comprehensive suite of multi-dimensional molecular analysis instruments, supporting both research and service applications. Backed by extensive project experience and a robust detection infrastructure, the platform delivers efficient, reproducible biomarker and pharmacodynamic endpoint testing across a broad range of studies. The platform also supports pharmacokinetic (PK) evaluation, including the assessment of small molecule and large molecule conjugated drugs.

Capabilities

Service Offerings

Blood Analysis (Biochemical Testing, Complete Blood Count (CBC), Glycated Hemoglobin (HbA1c), Coagulation Profile)
Immunoassays (ELISA, Western Blot, ELISpot, Co-Immunoprecipitation (IP))
High-Sensitivity Multiplex Platforms (Luminex, MSD, Simoa)
Omics & Sequencing (scRNA-seq, Proteomics, Metabolomics)
Mass Spectrometry (MS) and Liquid Chromatography (LC)
Large Molecule Analysis (mAbs, Bispecifics, ADCs, Peptides)
Small Molecule & Nucleic Acid Drug Analysis (Conventional Drugs, Nucleic Acid Drugs)
Cell and Gene Therapy Product Analysis

Platforms

Advantages

Extensive research experience to facilitate various project applications.
Stable and robust detection systems combined with efficient experimental delivery capabilities, enabling clients to accelerate their research timelines significantly.
Over 100 antibodies/kits optimized for human or mouse specificity, aiding in the validation and investigation of multiple treatment modalities in various disease indications.
Extensive experience in undertaking a wide range of PK testing projects, including the detection of small molecules, large molecules, and conjugated drugs.

Case Studies

Service Case Studies

Explore our validated studies demonstrating the efficacy of various therapeutic interventions.

Blood Analysis
Figure 1. Complete blood count test of C57BL/6JGpt strains.
Figure Legend. Detection data of WBC, RBC, HGB, and Lymphocytes (Lym) for C57BL/6JGpt mouse strains are presented across different weeks of age.

The hematology analyzer (Sysmex XN-1000V) detects more than 30 parameters with a processing speed of 2 minutes per sample and supports fully automated staining and dilution. Imported quality control materials are provided to monitor data quality, ensuring the reliability of test results.
Figure 2. Plasma LDL-C level
Figure Legend. Inclisiran (siRNA targeting PCSK9) decreased plasma LDL-C level in Western Diet (WD)-fed B6-hPCSK9-UTR hypercholesterolemia model.

Blood biochemistry testing is performed on the Hitachi 3500 analyzer, which supports qualitative and quantitative analysis of blood, body fluids (e.g., cerebrospinal fluid), excreta, and tissue samples. The system offers 100+ assay panels, requires as little as 30 μL of sample, processes up to 800 tests/hour, and includes automatic sample dilution.

Western Blot
Figure 3. Detection of CD98 protein levels in mouse spleen, kidney, lung, cerebellum, cortex, and hippocampus tissues.
Figure Legend. Human CD98 protein expression was high in G1 BALB/c-hCD98HC +/+ mice, lower in G2 BALB/c-hCD98HC +/- mice, and absent in G3 BALB/c mice.

Proteins are separated by polyacrylamide gel electrophoresis (PAGE) based on molecular weight, followed by transfer and immobilization onto a membrane support, and selective detection using an antibody-mediated reporter system. The panel covers over 80+ indices.

ELISA
Figure 4. Inclisiran inhibited plasma hPCSK9 level
Inclisiran inhibited plasma hPCSK9 level in a dose dependent manner in B6-hPCSK9-UTR mice via ELISA analysis.

ELISA detects solid-phase immobilized antigens using enzyme-labeled antibodies. The platform covers 100+ indices, processes 600+ samples/day under an established quality control system, and delivers results within 1–2 days.

PK
Figure 5. Serum Concentration-Time Profile (ng/mL)
Figure Legend. Test articles were administered to B6-hFcRn transgenic mice via subcutaneous injection at a dose of 10 mg/kg. Blood samples were collected over a 28-day period at 12 time points. Drug concentrations were determined by ELISA with a detection range of 31.25–2000 ng/mL

PK assays cover mAbs, bispecifics, Fc fusion proteins and mRNA drugs. Matrices include mouse, cynomolgus monkey, and human samples. Assay strategies include target capture, universal scaffold (LLOQ 6.25 ng/mL), and dual-platform cross-validation.

ELISpot
Figure 5. Mouse spleen cells were analyzed for mIFN-γ production by ELISPOT.
Figure Legend. Mouse spleen cells were collected as samples, and mIFN-γ production was detected by ELISPOT assay.

The assay is designed to detect and quantify low-frequency cytokines as well as antibody-producing cells.