Monitoring of Biopharmaceutical Processes: Present and Future Approaches

This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm.

Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing

Choosing the right tools to enhance the process.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes (Part 2)

Understanding the relationship between the process and CQAs.

QbD: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes—Part 1

Using multivariate experiments to define acceptable ranges.

Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit Operation

A review of some recent contributions in process chromatography.

Modeling of Biopharmaceutical Processes—Part 1: Microbial and Mammalian Unit Operations

Process-modeling tools can ensure smooth tech transfer.

Filter Clogging Issues in Sterile Filtration

A case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.

Applications of MVDA in Biotech Processing

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

Lifetime Studies for Membrane Reuse: Principles and Case Studies