Global Biotech Experts, LLC


Consulting Services

CMC (Quality) Analytical and Stability Studies

  • Product physiochemical and functional characterization
  • Preparation and characterization of product degradants
  • Characterization and control of process impurities (e.g. DNA and  HCP)
  • Host cell protein reagent development and ELISA validation
  • Phase-appropriate analytical comparability studies for process changes 
  • Phase-appropriate method life cycle studies (including in vitro bioassays):
    • Optimization/Re-optimization of problematic methods
    • Qualification (methods for characterization, comparability, biosimilarity studies)
    • Verification (original compendial methods)
    • Validation (non-compendial, or modified compendial, methods)
    • Tech transfer (lab to lab)
    • Method bridging (technology to technology)
  • Reference standard characterization, bridging and stability protocols
  • Forced degradation studies for establishing product stability profile and selection/validation of stability methods
  • ICH stability studies (target, accelerated and stress conditions)
  • Biosimilar/originator product analytical similarity studies
  • Immunogenicity screening assay development and validation
  • ADA neutralization assay development and validation


Laboratory Quality Practices and Inspections

  • Pre-Approval Inspection (PAI) readiness audits for analytical and stability CMC 
  • Remediation of GLP and GMP inspection observations
  • Due diligence audits for potential partnerships, mergers or acquisitions
  • Assessment of laboratory quality agreements with R&D and GMP contract testing organizations
  • Laboratory GMP compliance checks (including Part 11 elements)
  • Laboratory GLP compliance checks (including QAU monitoring)
  • Analytical method tracking/trending strategies
  • Gap analysis of quality practices and policies for OOS and deviations
  • GMP analytical Data Integrity gap analysis and remediation 
  • Quality practices for R&D laboratories
  • Data integrity for analytical biosimilarity studies
  • Data integrity for critical non-GMP CMC studies