Leveraging Computational Models of Glycosylation for Biopharma QA

Many biopharmaceutical developments contain oligosaccharides that affect their function, properties, and yield. CD BioGlyco utilizes specialized computer-assisted modeling services to help with quality assurance at different stages of biopharmaceutical development and manufacturing. The variability in glycosylation of biopharmaceuticals is mainly determined by the process conditions and development process. Our professional services team provides model building, model optimization, and predictive validation services. Moreover, we provide other Computational Glycoengineering-assisted Specific Modeling services such as In-silico Glycoengineering Prediction and TGP Glycosylation Prediction.

Glycosylation modeling

Glycosylation is a key quality attribute of biopharmaceuticals due to its close relevance to bioprocessing and its impact on pharmacokinetic safety, and pharmacodynamics. In biopharmaceutical development, glycosylation is influenced by nutrient availability, temperature, dissolved oxygen, ammonia, and pH. Glycosylation variability also exists between batches of the same drug. Relying on client-supplied data and advanced algorithms, our lab provides satisfactory predictive modeling services such as kinetic models, flux-based glycosylation models, or statistical models.

We provide not only online process inspection services but also services for predicting the impact of macro- and micro-phenomena on the yield and quality of biopharmaceuticals.

Cell line

Chinese hamster ovary (CHO) and murine myeloma (NS0 and Sp2/0) cell lines are commonly used in biopharmaceutical manufacturing. Our lab provides reliable In-silico cell line glycoengineering services to clients.

QA prediction

Our lab uses predictive modeling combined with multivariate data analysis (MVDA) to determine the correlation between critical process parameters (CPPs) and critical quality attributes (CQAs).

Another important service related to this modeling is the analysis of chemometric relationships between nutrients, metabolites, cells, and products. Moreover, we offer kinetic analysis services for biopharmaceutical processes.

Our lab provides accurate output glycoprofile prediction services based on the known chemical, physical, and biological phenomena governing the bioprocess.

Publication

Applications of Computational Model-assisted Biopharmaceutical QA Prediction

• Computational model-assisted biopharmaceutical QA prediction can be used for bioprocess characterization and data analysis.
• Computational model-assisted biopharmaceutical QA prediction can be used for cell line glycoengineering or development.
• Computational model-assisted biopharmaceutical QA prediction can be used for manufacturing bioprocess optimization and control.

Advantages of Us

• Our high-quality team of experts with diverse backgrounds in computational biology, bioinformatics, and biopharmaceutics provides comprehensive biopharmaceutical QA solutions for our clients.
• Relying on a team of professional computers and glycobiological information, the prediction services we provide are at the forefront of accuracy and reliability.
• Our researchers provide customized biopharmaceutical QA modeling services based on the client's project characteristics.

Frequently Asked Questions

• What is the classification of biopharmaceutical QA mathematical models and their advantages respectively?
  Biopharmaceutical QA mathematical models can be categorized into the following three groups:
  • Kinetic model: It covers all QA application areas.
  • Flux model: It is well suited to define cellular glycosylation strategies.
  • Statistical model: It is suitable for quantifying the correlation between bioprocess conditions and glycosylation.
• For the mammalian production hosts to be modeled, what are the categories of mechanisms included in their kinetic model?
  • Unstructured-unsegregated
  • Unstructured-segregated

  • Structured-unsegregated
  • Structured-segregated

CD BioGlyco provides diverse modeling services for biopharmaceutical QA prediction. Our professional researchers use computer systems to design, control, and optimize bioprocesses. Please feel free to contact us.

• Computational Model-assisted In-silico Glycoengineering Prediction Service
• Computational Model-assisted Therapeutic Glycoproteins (TGP) Glycosylation Prediction Service
• Computational Model-assisted Hyper-glycosylated Analog Design Service
• Computational Model-assisted Carbohydrate Antibody Development Service
• Computational Model-assisted Carbohydrate Antigen Development Service