Bioanalytical Services

BioA

 

Our bioanalytical laboratory services range from method/assay development, transfer, validation to sample analysis of small molecules, large molecules and biomarkers managed by highly experienced scientists. In fact, the majority of our bioanalytical scientists hold advanced degree credentials. Download the Frontage non-proprietary bioanalytical methods list.

Frontage supports our clients’ evolving bioanalytical needs through advanced instrumentation. Current equipment includes:

  • Simoa HD-1 Analyzer
  • MSD SECTOR S 600
  • Sciex API 6500, 5500, 5000, 4000 MS
  • Sciex API 6600 Q TOF  MS
  • Waters Xevo TQ-S MS
  • Agilent 7700x ICP-MS
  • ELISA plate readers
  • Chemidoc reader for electrophoresis and western blot
  • Tomtec and Tecan liquid handling systems
  • Tissue sample preparation using Covaris AFA ultrasonic extraction instruments equipped with cryogenic pulverization of hard tissues
  • UPS power supply protection LC-MS/MS systems

Global Operations

Both the United States and Chinese bioanalytical labs are managed under a single global quality standard and validated data system. This unified quality system enables Frontage to transfer and cross validate methods for clinical study support between our US and China labs. It offers multicenter clinical study sample analysis and a unified data report for multinational studies.

Excellence in Compliance

Frontage’s sophisticated operating systems hold an outstanding compliance record. We have a current CLIA certification, PA state DOH certification, and we are GLP compliant.

Integration for faster response times

Frontage has a dedicated sample tracking and sample management team. The sample management team carefully inspects each shipment against the study protocol requirements to ensure sample integrity and traceability. We have also developed systems to handle studies that require multiple shipments that enable organized laboratory workflows and timely completion of sample analyses.

Facilities

Frontage operates in the US and China with one seamless quality system. US facility highlights include:

  • Central security alarm monitoring system and 24-hourcard controlled facility access
  • Validated Watson LIMS system for centralized data storage and management
  • Incremental nightly data backup and full weekly and monthly backups
  • Tissue culture room
  • Secure sample storage
    • Sample inventories
    • Sample login to Watson LIMS
    • -20° C walk in freezers
    • -70° C freezers
    • On-site emergency power backup for all freezers
    • Freezer temperature monitoring with remote notification capability

Operating Systems

Our operation systems ensure optimal utilization of our technology and facilities. These include:

  • Integrated Quality Assurance using GLP and guidance from FDA and EMA
    • Project Management
    • On-site independent QAU
    • Periodic inspections from QAU, clients, and Quality Assurance consulting firms
    • Strict Quality Control process (technical, QC specialist, management, and QA)
    • Data qualified for regulatory submissions
    • Personnel training programs (ex. systematic GLP/technical/SOP training)
    • Sample tracking
    • Data handling and archiving