Bioanalytical Method Development and Sample Analysis

Achieve breakthrough results with Frontage Bioanalytical Services by partnering with experts in method development and clinical sample analysis.  Frontage outperforms competitors by remaining on budget while meeting aggressive project timelines and compliance requirements with substantially higher quality and success rates.  

 

Supervised by industry leading PhDs, this group resolves complex issues for projects ranging from discovery through late phase development of small and large molecules.

Download the Frontage nonproprietary bioanalytical methods list

 

Please let us know how our group of skilled experts – including a dedicated biomarker and peptide/protein qualification team – can assist you in meeting your goals with our advanced analytical instrumentation and proven systems in regulated bioanalysis.

 

Global Operations with Seamless Quality


Frontage Bioanalytical Services is fully integrated with our Preclinical, CMC, and Clinical services, enabling faster communication and turnaround.  Frontage is headquartered in Pennsylvania with substantial operations in China.  Both the US and China Bioanalytical labs are managed under a single global quality standard and validated data system (LIMS). 

 

This unified quality system enables Frontage to transfer and cross validate methods for clinical study support between our US and China labs.  It offers you multicenter clinical study sample analysis and a unified data report for multinational studies.  We are able to expedite import/export of biological samples and chemicals between the US and China with our streamlined shipping process.

 

Frontage Advantages

 

  • One of the best technical teams in the industry with high percentage of established PhD chemists
  • Excellent scale of operations in both the US and China, with one of the largest bioanalytical laboratories on the East Coast

  • A proven track record of developing and validating difficult, highly sensitive methodologies for small and large molecules

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

Here is a partial list of our service offerings:

 

  • Method development, validation, and rapid transition of methods between species and matrices according to current regulatory guidelines

  • Method transfer/cross validation utilizing quality control and incurred study samples

  • GLP sample analysis using LC-MS/MS and immunochemistry

  • Biomarker measurement using LC-MS/MS and immunochemistry

  • Dry matrix spot sample analysis (DBS, DPS, DUS, etc.)

  • 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 with both WinNonline and LIMS software

  • Sample tracking and management from reception to final disposition with LIMS and electornically monitored freezers

  • Clinical PK sample testing and evaluation

  • Bioequivalence studies with CTD report formatting

  • Therapeutic drug monitoring studies

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

  • Protein binding studies

Technologies


Frontage stays ahead of the technology curve with advanced instrumentation. 

Current 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

  • Agilent 7700x ICP-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

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