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Contract Quality Testing

  • Overview
  • Tests

Services Overview

We perform quality testing and analysis on all samples in the manufacturing process (raw materials, in-process controls, APIs, drug products, stability testing, etc.).
Utilizing the latest technology and expertise, we provide contract testing and analysis services in compliance with advanced biopharmaceutical regulatory requirements.

Certified GMP quality control capabilities and export capabilities for overseas products through regulatory inspections by national and international authorities.
Category Tests Stem Cells Immune Cells Exosomes AAV Lentivirus
Microbiological Tests Sterility Test
Mycoplasma Contamination Test
Endotoxin Test
Adventitious Virus Test
Physicochemical Tests Insoluble Particles & Precipitation Test
Conductivity & TOC Test
Size and Particle Count Test (NTA)
Osmolality & pH Test
Characterization Analysis Identity and Purity Test
Potency Test
STR (Short Tandem Repeat) Analysis Test
Mixed Lymphocyte Reaction / ADCC Test
Differentiation Test
Virus Titration
Functional Titration
Replication-Competent Virus Detection Test
Impuriting Testing BSA Impurity
Antibiotics
Host cell Protein
Benzonase
Host cell DNA
Plasmid DNA
Method Validation Mycoplasma detection
Sterility
Potency
Antibiotics

Process

STEP 01

Customer Inquiry

STEP 02

NDA Agreement

STEP 03

Scope Negotiation

STEP 04

Cost Estimation

STEP 05

Service Agreement

STEP 06

Perform Quality Testing

STEP 07

Issue Test Reports

Quality Analysis Equipment

  • Endotoxin Measurement

  • Cell Analysis

  • Nanoparticle Analysis

  • Rapid Sterility Testing

  • Density Measurement

  • Microvolume Spectrophotometry

  • Insoluble Particle Measurement

  • Cell Counting

  • Ultra High Performance Liquid Chromatography (UHPLC)

  • Nucleic Acid Amplification Analysis

  • Nucleic Acid Amplification Analysis

  • Nucleic Acid Amplification Analysis