Taking the individual bias out of examining comparability of biosimilars: A case study on monoclonal antibody therapeutics.

Biosimilar manufacturers need to perform analytical and functional similarity assessments against the reference product. Successful demonstration allows for an abbreviated clinical path, thereby translating to affordable biosimilars. Current practices for regulatory concurrence on analytical similarity data are based on chart visualization and open to individual (human) bias.

Neural network-based fingerprinting of monoclonal antibody aggregation using biolayer interferometry.

Aggregates are widely accepted to be a critical quality attribute (CQA) for biotherapeutics and believed to impact product immunogenicity. Monitoring of aggregates is typically performed using multiple orthogonal tools as any single tool is unable to offer comprehensive characterization of aggregate species over the entire size and morphology range that they can exist in. Researchers have attempted to categorize monoclonal antibody (mAb) aggregates into six classes based on their respective physicochemical properties.

Comparison and implementation of different control strategies for improving production of rHSA using Pichia pastoris.

Recombinant protein production by various host organisms is strictly regulated, which is determined mainly by host cell genetics and maintenance of process variables within desirable limits in a reactor. Since the process dynamics typically exhibit nonlinear interactions amongst the critical process variables, the commonly employed controllers are suboptimal for control of most bioprocesses. In this article, we present the implementation of an augmented controller for improving the production of recombinant human serum albumin (rHSA) using Pichia pastoris.