Pharmaceutical Engineering & Drug Delivery

The development of fundamental models for fed-batch pharmaceutical processes range from very challenging to almost impossible as not all the inner workings of the process are quantitatively known. Thus, the accurate calculation of the Design Space in which the process will be operated is a...

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...

Inhalation Powders have become an important dosage form in developing products for delivery to the lungs. Since the approval of the first DPI in the US in the late 1990’s there has been a rapid surge in the number of drug development programs involving Dry Powder Inhalers. The draft MDI/DPI...

Dissolution testing is routinely carried out in the pharmaceutical industry to determine the rate of dissolution of solid dosage forms. This test is one of the several tests that pharmaceutical companies typically conduct on oral dosage formulations (e.g., tablets) to determine compliance. The USP...

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...

The Food and Drug Administration requires from pharmaceutical companies the development of extensive knowledge databases regarding the control of the manufacturing process of a drug product. Through development and validation, drug manufacturers discover their process boundaries and identify a...

As an essential milestone for both the cGMP for the 21 st Century and the recent pharmaceutical quality regulatory initiatives (Q8/Q9/Q10), the 2004 FDA Guidance for Industry “PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance” has proposed a science-...

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...