Overview

To keep us — and you — out in front, Frontage has built an exceptional bioanalytical services unit with strong scientific and regulatory knowledge and extensive industry experience. We support research projects from discovery through late phase drug development by combining the best analytical instrumentation with skilled experts in method development and sample analysis. With a proven track record of developing and validating difficult, highly sensitive methodologies, we are continuing to grow and striving to operate the best bioanalytical laboratories in the industry.

 

Frontage Advantages

  • One of the best technical teams in the industry with high percentage of Ph.D. chemists working on the bench

  • Excellent scale of operations in both the US and China, with one of the largest bioanalytical laboratories on the East Coast

  • International clinical trial support with globally-managed quality system, equivalent equipment and personnel training programs and a secure, validated data management system (Watson LIMS™)

  • Integrated project management and sample management teams that closely monitor the preclinical and clinical study progression against project protocols to ensure timely execution of sample analysis and coordination with in-life study centers

  • Working closely with you, we develop a project strategy to meet specific needs, time requirements and budget constraints

Frontage bioanalytical services can be applied throughout the drug development spectrum. We offer:

  • Method development and validation

  • Analyte stabilization techniques and custom tube preparations

  • In vitro half-life studies to simulate product degradation in various biological matrices

  • PK/TK analysis for preclinical and clinical studies using validated software

  • Clinical PK sample testing and evaluation

  • Bioequivalency studies with CTD report formatting

  • Therapeutic drug monitoring studies

  • Drug-drug interaction study support with many validated, multi-analyte methods

  • Protein binding studies

Facilities and Technology


Frontage resources include:

  • Applied Biosystems API 4000, Q-Trap and 5000 MS/MS systems equipped with high-throughput HPLC and UFLC capabilities designed for prevention of analyte carryover

  • UV and fluorescence detection HPLC systems

  • GC/MS

  • Tomtec and Tecan liquid handling systems for automation of sample preparation

  • Tissue sample preparation using Covaris AFA ultrasonic extraction instruments, equipped with cryogenic pulverization of hard tissues

  • Watson™ LIMS system for data management and reporting, centralized and secured for operation in both US and China facilities

  • Central security alarm monitoring system with 24-hour card-controlled facility access

  • On-site emergency power backup for all sample storage freezers (-20°C, -70°C)

  • Freezer temperature monitoring with remote notification capability

  • AC power failure monitoring systems with immediate notification capability

  • Incremental nightly data backups, full weekly and monthly backups