Pharmaceutical Engineering & Drug Delivery

Scaling up strategy for continuous powder mixing process Yijie Gao, Fernando Muzzio and Marianthi G. Ierapetritou Dept. of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ 08854 Continuous powder mixing has attracted a lot of interest among pharmaceutical industry. Based on...

Scale and Bioreactor Design Translation for Rocking Bag Bioreactors. The translations of scale and bioreactor designs for disposable rocking bag bioreactors are currently performed intuitively or with trial an error approaches. Conditions are typically based on manufacturer recommendations or...

Modeling has always been a powerful weapon in a chemical engineer’s arsenal. Use of modeling should be considered a key piece in the application of Quality by Design (QbD) in drug substance and drug product development. In this study, reaction, dissolution and growth kinetics are determined for a...

In the Quality by Design (QbD) framework, there is a significant emphasis on the robust characterization of manufacturing processes and prospectively identifying the engineering design space that ensures product quality. Although the QbD approach is expected to bring about significant long-term...

The design space may be interpreted as the constrained region of the key manufacturing parameters space which provides assurance of quality of a drug given that manufacturing occurs in this region. The metric used to represent this assurance should not be deterministic, rather it should be stated...

Design of experiments, followed by numeric and graphical optimization, is frequently used by engineers to optimize a process, and to define a design space or operating window. It is critical to understand the boundaries of this operating window – if you choose a specific set of operating conditions...

Quality by Design principles are well established in the pharmaceutical industry. It is becoming common place to develop the design space for a drug product and include it in the regulatory filing. There are a broad range of methods to establish design space, some of which are focused on individual...

Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example. Why? Because the behaviour of fine cohesive particle behaviour is notoriously complex, and notably more so than any single phase solid, liquid or...

The employment of single-use technologies in the downstream processing of biologics in general and monoclonal antibodies in particular is gaining significant traction in the industry. Their use eliminates cleaning validation requirements and can potentially offer significant savings in capital...

This presentation focuses on some key developments in understanding the relationships between the governing properties of DPIs and how these properties can be harnessed to develop designer formulation systems for DPIs.