Analytical Testing
ABL maintains a robust in-house analytical function providing a wide range of product-specific and compendial Quality Control (QC) methods for viral vector and protein products.
ABL’s analytical services include methods development, transfer and optimization, qualification and full validation respective to the phase of clinical development; supporting QC release and stability testing according to ICH guidelines.
Virus-based QC and bioanalytical testing services
Analytical
Method
Transfer
Analytical
Method
Development
Phase
Appropriate
Qualification
Analytical
Validation
GMP QC
Release/Stability Testing
Safety
- ⦁ Sterility
- ⦁ Mycoplasma
- ⦁ Bioburden testing
- ⦁ Endotoxin testing
- ⦁ Adventitious agents
Purity
- ⦁ Western blot testing
- ⦁ HPLC testing
- ⦁ SDS PAGE
- ⦁ Residuals testing
Potency
- ⦁ Plaque assay testing
- ⦁ TCID50 testing
- ⦁ ELISA testing
- ⦁ Digital PCR and qPCR testing
Quality
- ⦁ Total protein
- ⦁ pH/Appearance
- ⦁ Osmolality
Virus-based QC and bioanalytical testing services
- ⦁ Custom, product specific testing
- ⦁ Quick turnaround time
- ⦁ We establish the method to optimize and qualify
- ⦁ We excel at consistency, which serves as an indication of quality, standardization and data reliability
- ⦁ Collaborative work ethic, we work with our clients as an extension of their lab
- ⦁ Clients feel ownership of project by having access to information constantly
- ⦁ ABL provides weekly updates to clients so they can weigh in on real-time data before data reports are finalized
- ⦁ We empower companies to make critical decisions quickly, sharing real-time data to advance their innovations forward
QC platforms
- ⦁ Waters HPLC/UPLC - ACQUITY H-Class BIO QSM and 2695 HPLC
- ⦁ Beckman Coulter Vi Cell XR Cell Viability Analyzer
- ⦁ GE/Seivers TOC Analyzer
- ⦁ BioRad Digital PCR and qPCR
- ⦁ CRL Endosafe Endotoxin Analyzers
- ⦁ Advanced Instruments Osmometer
- ⦁ Multiple UV/Vis Microplate Readers (molecular devices)
- ⦁ Other – Imaging Densitometer, Gel Imaging system, Fluorometer, Electrophoresis equipment, and other associated analytical
