Biopharmaceutical

 Engineering
  Process
  PLC Security
  Start Up/Commissioning
  Automation
  Specifications
  Project Management
  SOP Development

 Validation
  Analytical Methods
  Cleaning
  Equipment
  Clean Utilities
  Process
  Control Systems
  Regulatory/Audits
  Risk Assessment
  Inspection Support
  Project Management

 Specialization
  DCS/BAS
  CIP/SIP
  Cell Culture
  Controlled Environment
  Viral Reduction
  Separation Processes
  Fill-Line Equipment
  Aseptic Sampling

 



Analytical Method Validation and Qualification

ADVENT provides Analytical Method Validation and Qualification consulting services for all phases of Biopharmaceutical manufacturing.

Analytical Method Validation and Qualification Services:

  • Physical Property Determination
  • Chromatographic Assays
  • Cell Based Assays
  • Binding Assays
  • Chemical Assays
Analytical Equipment Experience:
  • TOC Analyzers
  • Spectrophotometers - UV-Vis, FT-IR, Mass Spectrophotometers
  • BIACore 3000 Bimolecular Interaction Analyzers
  • Flex Stations
  • Capillary Electrophoresis
  • Chromatographic Assays
  • Cell Based Assays
Analytical Method Validation Experience:
  • pH & Osmolality
  • Protein Concentration A280
  • TOC Method Determination - LOQ Determination
  • Binding Assays for Pro A Using ELISA
Analytical Method Qualification Experience:
  • Chemical Assays - SDS Page
  • Binding Assays - ELISA
  • Chromatographic Assays - CEX, SEC

 

For more information about our services and products: Contact Us