Analytical Development

With EMA & SFDA inspected GMP laboratories, WuXi provides full range of analytical services, including method development and validation, analytical testing and release, stability study, large scale separation and regulatory CMC documentation services. State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

Analytical/Stability/CMC Package for IND/CTA, NDA/MAA & ANDA

  • End-to-end services with high quality and fast turnaround time providing cost effective solutions
  • One stop shop for all needs in analytical & stability, quality control and regulatory CMC documentation
  • Package qualified for both China and global submission (“China for China” and “China for global”)

Method Development and Validation

  • A wide range of chromatography techniques (HPLC, UPLC, GC, and IC) and detection technologies (UV, MS, MS/MS, CAD, ELSD, RI, FID, ECD, ICP, Florescence, etc) to meet the requirements of different types of compounds
  • Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules/liquid filled capsules, solution/suspension, powder, beads/coated beads, injectables, topicals, solid dispersion, etc)
  • Other specific methods, like dissolution (IR, ER, MR), residual solvents, potential genotoxic impurity, enatiomeric separation, cleaning validation, counter-ion, microbiological test, etc
  • Provide method development experimental design, progress report, method validation protocol and report, method monograph
  • Phase appropriate approaches – qualified for IND/CTA or NDA/MAA application

Analytical Testing and Release

  • Full or customized release for API and drug product (GMP or GLP)
  • Analytical support for formulation development and cleaning validation
  • Reference standard characterization with CoA or full characterization report
  • Full excipient release as per USP, EP, ChP or JP
  • Confirmation of structure or absolute configuration determination
  • Structure elucidation for impurity/degradation product by LC/MS/MS and a variety of NMR spectroscopy
  • Degradation pathway ascertainment with report for regulatory submission
  • Leachable/extractable testing
  • Microbiological testing: microbial limit, endotoxin, bioburden, water, sterility testing, environmental monitoring, etc

Stability Study

  • Global registration stability; experimental/probe stability; post-approval commercial stability
  • Comprehensive services with stability protocol design, program management, storage and testing, data trending/shelf life assessment up to dossier preparation for NDA/MAA application
  • Storage conditions: 40°C/75%RH, 30°C/75%RH,
    30°C/65%RH, 25°C/60%RH and light or customized conditions including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20, 50/40 (new)
  • Storage capacity of currently > 500 m3 reaching 1,000 m3 in 2013/2014
  • Qualified stability rooms/chambers (IQ/OQ/PQ and mapping); multiple types of power supply; real time temperature and humidity monitor (dual systems); autodial alert system

Large Scale Separation

  • SFC or HPLC technology for chiral and achiral separation under development or GMP mode to support process chemistry (API or intermediates)
  • Systematic method development approach with column/modifiers screening platform
  • Quick turnaround time with competitive cost, ability to separate up to 50kg racemate within 1 month

Regulatory CMC Documentation

  • Dedicated regulatory writing group with strong documentation experience and proven track record for global and China submission
  • CTD-format with version control or customized to meet local requirements
  • Further integration with IND-enabled toxicology and clinical and regulatory services