Analytical & Quality Control
Home | Services & Solutions | Analytical
With over 3,500 analytical scientists at each of our development and manufacturing sites, we provide a full suite of analytical services to support projects from discovery to pre-clinical and clinical development, all the way through to commercial manufacturing for both drug substance and drug product programs. These services encompass small molecules, oligonucleotides and peptides.
Our dedicated teams provide a full spectrum of analytical method development, validation and testing services, including all general and unique testing capabilities to support your needs.
Analytical Services
- drug substance and drug product analytical method development and validation
- drug substance and drug product release testing ICH stability studies
- reference standard characterization and qualification
- potential Genotoxic Impurities (PGI) method development, validation, and testing
- impurity / degradant isolation and structure elucidation
- highly potent compound analysis
- packaging system evaluation, including Container-Closure Integrity Testing (CCIT)
sterility testing and species identification
Track Record：
- 12,000+ chromatographic and 2,000+ non-chromatographic methods developed in 2023
- 500+ structure characterization for IND/NDA fillings in 2023
X-ray Powder Diffraction (XRPD)
Quality Control
- method validation (IND/NDA, commercial)
- full release testing (raw materials, reagents, drug substance and drug product)
- cleaning verification for manufacturing
- ICH stability study
Track Record:
- 10,000+ drug substance and 1,000+ drug product batches released annually
- successfully passed 50+ Pre-Approval Inspections (PAIs) from global regulatory agencies
Key Equipment
- Chromatography: UPLC, HPLC, Nano HPLC, GC, IC, SEC, SFC
- Mass Spectrometry: QTOF, MALDI-TOF, LC-Orbitrap, LC-MS, 2D LC-MS, GC-MS
- Solid State Characterization: XRPD, DVS, DSC, TGA with MS interface, PSD, nano-particle size analyzer, polarized light microscope, SEM, surface area analyzer
- Identification: NMR, HRMS, FT-IR
- Elemental Analysis: ICP-OES, ICP-MS
NMR 600MHz
Drug Product Analytical Teams
Unique capabilities:
- End to end analytical development for both oral and parenteral drugs with various of dosage forms and filling formats
- Genotoxic impurity evaluation and testing platform with 1,500+ GTI database and 2,000+ method database
- High potency drug product analysis for both oral and injectable dosage forms
Track Record:
- 2,000+ clinical projects including 40+ late phase projects
- Successfully submitted 500+ IND dossier files and 35+ NDA/ANDA dossier files
Drug Product Quality Control Teams
Capabilities and Track Record:
- 1,000+ batches released annually, 3,000+ ongoing stability batches
- Digital systems LIMS & ELN & Trackwise & Veeva & Empower
- Dedicated high potency QC laboratories
- Successfully passed all inspections from various regulatory agencies including FDA, NMPA, PMDA and EMA.
