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LC-MS solutions

Advancing your molecule requires access to specific scientific expertise, alignment with changing regulatory requirements and flexible resources matched to your study’s unique demands. Come partner with us today.

Method development and validation

Methods delivered to the highest global regulatory standard with the ability to transfer your assay among our nine global facilities with the help of our dedicated scientific team.

From idea to execution

Take advantage of the world’s broadest range of compound knowledge, scientific expertise and efficiency in method feasibility, development, validation and transfer for bioanalysis. Our highly trained technical staff develops robust methods using the latest technologies to deliver consistent performance throughout your large- or small-molecule program.

Seven global sites. One global method standard.

You have the flexibility to transfer methods among any of our seven global facilities. Our scientists routinely establish and validate more than 1,400 proprietary and nonproprietary bioanalytical methods annually.

A Broad Array of Studies to Meet Your Needs

Preclinical and clinical sample analysis

From preclinical to late stage clinical, receive end-to-end support for a wide range of study types to move your program forward.

 

Nonclinical toxicokinetic (TK) studies

We’ll support your mammalian toxicology studies with TK data to correlate safety and drug blood concentration levels in animal models.

Clinical PK/Bioavailability studies

We support your early clinical single or multiple ascending dose through late stage studies with robust methods to establish optimal dosage and dose frequency.

Bioequivalency studies

Our team will partner with you to compare pharmaceutical alternatives to evaluate therapeutic equivalents.

Therapeutic drug monitoring studies

We provide an integrated service with our Central Laboratories to help you reduce errors, provide chain-of-custody sample tracking, coordinate sample shipments and integrate your reports for regulatory submissions.

 

Drug-drug interaction studies

We’ll help you with robust methods and rapid data turnaround time to assess the potential impact of drug-drug interactions. We publish all nonproprietary methods.

 

PK-TK analysis and reporting

You’ll get comprehensive statistical data analysis for TK report integration into regulatory submissions using WinNonLin® and SAS™.

Immunoanalytical

Assess your drug’s immunogenicity profile with our proven three-tiered approach.

New Approaches to biopharmaceutical analysis

When it comes to developing your biologic, our team understands there is no standard path and each compound requires a unique solution. As your partner, we take the time to understand the complexity of your molecule and work with you to develop a solution for your program.

Experience Counts

When you partner with our team, you’ll get unmatched experience and expertise. We offer regional and global solutions with access to:

  • A team with more than 35 years of experience supporting large-molecule development
  • Expertise in biotherapeutic analysis by LC-MS to provide you the efficiency, selectivity and robustness essential for large-molecule studies
  • Innovative technology platforms e.g., Gyros™, MSD, ELISA, AB Sciex, Hamilton Star®,  and Bio-Plex® to deliver efficient quality results
  • Integrated bioanalytical solutions to support your non-regulated and regulated nonclinical for discovery and safety assessment
  • Single and multisite clinical programs for Phase I-IV and central labs

 

A Three-Tiered Approach to ADA Assessment

The FDA, EMEA and other regulatory agencies recommend thorough immunogenicity assessment of your drug's immunogenic potential. We bring more than 30 years of experience to the construction and implementation of a three-tiered strategy to assess the immunogenicity of your biologic:

  • Screening
  • Confirmatory
  • Titer assessment

 

Microfluidics

When facing challenges with low volumes you can rely on our highly sensitive assays and LC-MS expertise to deliver unique solutions.

Solutions to low-volume sample analysis

Does your study produce low sample volumes, creating bioanalytical challenges? We understand that capillary microsampling is gaining popularity due to ethical and scientific advantages. 

Our experienced team has a demonstrated track record of delivering quality results for high sensitivity assays with low sample volumes. As your partner, we can deliver unique solutions when you’re challenged with low sample volumes.

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