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ADDRESSING THE CHALLENGES IN MAINTAINING AND ANALYZING BIOTHERAPEUTIC GLYCOSYLATION

As the market for biopharmaceuticals continues to grow, manufacturers are increasingly challenged to improve their process efficiency while maintaining in vivo safety and efficacy profiles. Foremost of those challenges is minimization of batch-to-batch variability in product profile. Heterogeneous glycosylation patterns—a critical quality attribute (CQA)—as well FDA and EMEA mandates to demonstrate comparable glycan profiles represent daunting product consistency and analytical challenges. In this live webinar, we discuss the complexities of glycosylation, its implications in bioprocess development, and tools enabling precise control, quantitation, and characterization of glycan profiles. Our fully integrated solution of easy sample prep, high-throughput instrumentation, and glycan analysis-specific software offers a platform for streamlined solutions for biotherapeutic manufacturers.