Highlights•Mathematical models as tools to establish quantitative links between bioprocess
CPPs and KPIs.•Review of the advantages and limitations of mechanistic and statistical …

Today's biologics manufacturing practices incur high costs to the drug makers, which can
contribute to high prices for patients. Timely investment in the development and …

Ensuring consistent high yields and product quality are key challenges in biomanufacturing.
Even minor deviations in critical process parameters (CPPs) such as media and feed …

The production of monoclonal antibody (mAb) therapeutics, a rapidly growing multi-billion-
dollar enterprise in the biopharmaceutical industry, faces major challenges in achieving …

The emerging field of biotherapeutics provides successful treatments for various diseases,
yet immunogenicity and limited efficacy remain major concerns for many products …

Exerting control over the glycan moieties of antibody therapeutics is highly desirable from a
product safety and batch‐to‐batch consistency perspective. Strategies to improve antibody …

While machine learning (ML) has made significant contributions to the biopharmaceutical
field, its applications are still in the early stages in terms of providing direct support for quality …

The formation of inclusion bodies (IBs) during expression of recombinant therapeutic
proteins using E. coli is a significant hurdle in producing high-quality, safe, and efficacious …

Metabolic modelling strives to develop modelling approaches that are robust and highly
predictive. To achieve this, various modelling designs, including hybrid models, and …

Abstract Systems glycobiology aims to provide models and analysis tools that account for
the biosynthesis, regulation, and interactions with glycoconjugates. To facilitate these …