Analytical Testing Services from Azzur Labs

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Our Services

Azzur Labs Advanced Therapeutics Testing Services are located alongside our Azzur Cleanrooms on Demand™ Facilities. Our on-demand cleanrooms concept, coupled with our Advanced Therapeutics Testing services, enables a unique and unconstrained GMP solution for Advanced Therapy development and manufacturing.


Assay and Protocol Development:

(Compendial & Non-Compendial)
  • Development 
  • Qualification 
  • Validation 
  • Tech Transfer & Method Lifecycle Management

Study Design and Execution

  • Process Design, Scale-Up, and Performance Qualification

  • Campaign

  • Phase-Appropriate Sampling Plan

  • Product Stability And Process Comparability Studies

  • Continued Process Verification and Annual Product

  • Quality Review

Analytics/Bioanalytical Testing

  • Pharmacokinetics and Pharmacodynamics

GMP Product Release
  • Product Purity
  • Safety
  • Identity
  • Dose / Strength
  • pH
  • Potency
  • Osmolality
  • Appearance
  • Particulate Detection

  • Reagent Qualification

Characterization of:
  • Plasmid
  • sgRNA
  • Vector
  • Apheresis
  • Process
  • Drug Substance
  • Product

  • Comparability and Stability Studies

We specialize in:

  • Cell-Based Bioassays & CFU for Product Potency
  • Phenotype Assays By Flow Cytometry
  • Cell Counts And Viability 
  • Gene Expression Assays
  • Vector Copy Number And Viral Titer
  • Host Cell DNA 
  • Rapid Mycoplasma 
  • Rapid Sterility 
  • Endotoxin 
  • Metabolite Detection 
  • Chromosomal Translocation, On- And Off-Target ITR-Seq 
  • Flow-Fluorescence In Situ Hybridization (Fish) Assays 
  • Immunoassays By ELISA, MSD, and Western Blotting
  • Adenosine 5’-Triphosphate (ATPp) and Adenosine 5’-Diphosphate (AMP) Measurement
  • Chromatography Tests
How Can We Help?
From Discovery To Delivery™