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.

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-base 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

Reach out to our QC Specialists today!