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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
