September 2022 Featured Report

Development of a Stand-Alone Monitoring Application for Purification Processes in Biomanufacturing

by , , and

The ability to monitor unit operations in biomanufacturing is essential because it enables early fault detection and effective root-cause analysis. Below, we present a case study on the development of a stand-alone, data-driven, process-monitoring application for a biomanufacturing purification process. We review the application’s functionality and highlight its utility using a few examples from commercial manufacturing of a therapeutic protein. Lessons learned from the development of that application also are presented. The progress and performance of a purification process have…

September 28, 2022

Mechanistic Modeling for a Hydrophobic-Interaction Chromatography Process: Use in Vaccine Antigen Purification

by , , , and

Bioprocess models and simulations are the basis for digital twins, which are virtual representations of physical processes and enabling methods of biopharma 4.0. Early adopters in the industry have shown potential application of this approach in nearly all stages of a product development life cycle. Experts in academia and the biopharmaceutical industry have studied mechanistic modeling as the main method of chromatography modeling. Mechanistic models are mathematical descriptions of physiochemical phenomena. They are based on first principles and thus can…

September 28, 2022

Appropriate Estimation of Long-Term Variability: Using Biopharmaceutical Release and Stability Data

by

Numeric results from quality attributes testing of drug product and drug substance lots can be used for different statistical analyses. One study is the calculation of statistical tolerance intervals from lot-release data to assist in the determination of specification acceptance criteria (1). Data from manufactured batches placed on stability at the recommended storage condition (RSC) also can provide useful information to estimate long-term variation. Below, I address potential concerns associated with pooling disparate data sources and illustrate a technique to…

September 28, 2022

Increasing Reproducibility of Cell Culture Bioprocesses

by , and

Reproducible cell growth and reliable development of a desired product are ideal outcomes for a bioprocessing engineer. If reproducibility is poor, the risk of needing to discard a batch and repeat an entire bioprocess is high and results in a great loss of time and resources. Cells, culture media, and a bioprocess control system are required components of an upstream bioprocess. Each of those can be a source of variability that affects cell growth and viability as well as product…

September 28, 2022