Analytical Testing Services from Azzur Labs

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.

Services

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?

Enabling Acceleration & Risk Mitigation in Advanced Therapy Medicinal Product (ATMP) Development & Beyond

Whitepaper

Enabling Advanced Therapies by Solving CMC Challenges: A Quality Control Solution

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