Biopharma

 

inicialWe at Applied Bioanalytics know that each new generation therapeutics is unique, as are the teams developing them. Our analysts, scientists and engineers serve our clients with expert support that fit their bioanalytical needs with cutting edge technology. We provide our clients with comprehensive solutions together with reliable data. We offer personalized and comprehensive services based on, industrial standard procedures and detailed knowledge of regulatory requirements. We at the same time, are ready to address each project’s unique needs by being ready to develop new methodologies and finding novel solutions.

 

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  • High resolution glycan profiling

N-glycan composition profiling is essential for quality testing of biotherapeutics because the glycan structure is designated as a critical quality attribute (CQA) that must be monitored during manufacturing. The glycan profile of a finished product is used to assess the consistency of a manufacturing process from batch to batch. Our capillary electrophoresis separation based glycan profiling technology enables extraordinary resolution, which cannot be addressed by LC methods alone.

  • Automated carbohydrate sequencing

In addition to high resolution glycosylation profiling, carbohydrate sequencing is an important part of bioprocess analysis, especially when clients have unknown peaks in their sample. In glycan sequencing, carbohydrates are sequentially digested by various linkage-specific exoglycosidase enzymes allowing complete, high confidence structural elucidation for biological-relevance exploration or structural identity confirmation. Our in-house developed and validated semi- and fully-automated sequencing methods ensure robust and fast service not available from other companies.

  • Purity and heterogeneity measurements

Precise determination of low-level impurities of biologics is a challenging bioanalytical task through the entire biologics and biosimilar development pipeline. Biopharma analytical laboratories require quantitative and validated data, which is exactly what Applied Bioanalytics offers via utilization of the CE-SDS-MW method. High quality CE-SDS data provides the critical confidence required for right decision-making – not necessarily available using other technologies.

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  • Charge variant analysis

Working with biologics, especially with mAbs, requires information on different charge variants to determine identity and stability. By capillary isoelectric focusing we offer our clients ultra-high resolution charge heterogeneity data. cIEF is inherently consistent allowing global assessment, which is critical to both R&D and meeting regulatory requirements.

  • Charge heterogeneity

Similar to charge variants, charge heterogeneity is a critical quality attribute having significant importance for biologics. By capillary zone electrophoresis Applied Bioanalytics provides the required data. Due to our improved sample preparation protocol our clients can be confident in their results.

 


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