Pharmaceutical Engineering & Drug Delivery

Scaling up Strategy for Continuous Powder Mixing Process

Oct 19, 2011
Yijie Gao
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

Oct 19, 2011
John Bowers
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...

Quality by Design for DPIs -A Regulatory Perspective

Oct 19, 2011
Prasad Peri
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...

Design Space Definition Using a Variational Bayes' Approximation

Oct 19, 2011
Linas Mockus
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...

Managing Uncertainty In Design Space

Oct 19, 2011
Patrick J. Whitcomb
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...

Design Space Verification for Tablet Dosage Form Using Modeling

Oct 19, 2011
Mary T. am Ende
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...

Dynamic Design Space As An Integrated Component of Quality by Design

Oct 19, 2011
Carl A. Anderson
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...

QbD In Dry Powder Inhaler Development

Oct 19, 2011
David Morton
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...

Use of Single-Use Technologies In Downstream Purification of Mabs - A Case Study

Oct 19, 2011
Venkatesh Natarajan
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...

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