Our biopharma services include the separation and characterization of N-glycans as criticalquality attributes (CQAs) for monoclonal antibodies (mAbs) and other glycosylatedtherapeutic proteins. We also deliver extensive protein-level purity testing, stability assessments, and regulatory evaluations. These services are designed to uphold the highest standards in the development of therapeutic proteins and quality assurance, ensuring the integrity and effectiveness of novel biopharmaceutical products.
1. N-linked oligosaccharides: N-glycan analysis and enzymatic sequencing via CGE-LIF for ensuring product quality, as glycosylation can impact protein stability, efficacy, and safety.
2. Size heterogeneity and purity assessment: Size-based protein separation and determination by SDS-CGE to confirm the purity of biologics. This guarantees that patients receive a consistent and safe protein products.
3. Protein charge heterogeneity analysis: Analysis via CZE-, and CGE-UV enables the determination of protein charge, which can affect product stability, efficacy, and safety.
4. Protein charge variant analysis: Analysis of protein isoforms based on their electrical charge differences via cIEF provides valuable insights into protein product attributes and enabling effective quality control.
5. pDNA analysis: pDNA isoforms are used in gene therapy and vaccine production. Their determination via CE-LIF ensures the integrity and purity of these critical components in biopharmaceutical development.
6. DNA and RNA quantification: Quantification of viral vectors used for gene delivery or vaccine production by qPCR.