Pharmaceutical Engineering & Drug Delivery

Challenges, Opportunities, and Scientific Aspects of Implementing PAT In Biopharmaceuticals

Oct 19, 2011

Huiquan Wu

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-...

Transferring Monitoring Models Between Different Scales Through Multivariate Statistical Techniques

Oct 18, 2011

Emanuele Tomba

The challenge of transferring a process monitoring model across different scales is a different problem than the one addressed in previous studies that have focused on transferring operating procedures looking to produce the same grade of product [1, 2, 3, 4]. In the development of a new...

CMC Reviewer Expectations for ANDAs Using QbD Approaches

Oct 18, 2011

Robert L. Iser

There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA. There are particular challenges for generic drug manufacturers with respect to using QbD approaches, especially with more complex dosage forms, such as modified...

PAT Application and Validation of Online Particle Sizing Measurement for Controlling a Critical Quality Attribute

Oct 18, 2011

Kevin J. Bittorf

In accordance with ICH Q8/9/10 and the FDA QbD initiative, companies are adding more and more PAT equipment, installing more sophisticated control systems, and moving to real-time release. Throughout this process, many questions have come to light. How is PAT justified for controlling quality...

Mechanistic Models and Computer Software for Quality by Design In Formulation of Modified Release Dosage Forms

Oct 18, 2011

Xiao Yu Wu

Modified release dosage forms (MRDFs) can be designed and manufactured in various shapes and structures using different materials. Depending on the design, formulation and properties of drug and excipients (e.g. polymers), drug release from MRDFs can undergo varying mechanisms. In addition, the...

Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets

Oct 18, 2011

Mary T. am Ende

An asymmetric membrane (AM) tablet was developed for a soluble model compound to study the in vitro drug release mechanisms in challenge conditions, including osmotic gradients, concentration gradients, and under potential coating failure modes. Porous, semipermable membrane integrity may be...

Understanding the Impact of the Properties of Raw Materials Onto Product Quality Using JR-PLS

Oct 18, 2011

Salvador García-Muñoz

Multiple proposals are found in literature to analyze the impact of raw materials onto product using data analysis. From the methods proposed, the L-PLS is the only method that not only considers the ratio in which ingredients are mixed, but also the physical properties of the lots of raw material...

Optical Coherence Tomography: A New PAT-Tool for Fast and Non-Destructive Analysis of Tablet Coating Quality

Oct 18, 2011

Daniel M. Koller

Optical coherence tomography (OCT) is a non-invasive imaging technique allowing fast and high-quality cross-sectional imaging of semi-transparent and turbid media. Biomedical research and diagnostics have been up to now the main driving forces for the reported applications and progress in OCT. The...

De-Risking Scale-up of a High Shear Wet Granulation Process Using Latent Variable Modeling and near Infrared Spectroscopy

Oct 18, 2011

Koji Muteki

In the development of wet granulated drug products, two primary sources of variance (disturbance) include the operational scale of the high shear wet granulation (HSWG) process and Active Pharmaceutical Ingredient (API) lot-to-lot variability, particularly for formulations containing a high drug...

Insights Into Lactate Metabolism Through Multivariate Analysis of Cell Culture Bioprocess Data

Oct 18, 2011

Huong Le

Multivariate data analysis has recently emerged as a critical tool to gain fundamental understandings of process characteristics, and thus assisting the search for possible intervention means to improve process performance. The time dynamics of 150 process parameters acquired from 243 production...

QbD for Generic MR Drug Products

Oct 18, 2011

Yue (Helen) Teng

The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among other things),...

Building a Better Biofuel Production Platform

Oct 17, 2011

Stevan Albers

Building a Better Biofuel Production Platform: Engineering metabolic control techniques to control the photosynthetic cyanobacterium Synechocystis sp. PCC 6803 Stevan C. Albers 1 , Christie A.M. Peebles 1,2 1 Cell and Molecular Biology Graduate Program, 2 Department of Chemical and Biological...

Enhanced Xylitol Production Through Simultaneous Co-Consumption of Cellobiose and Xylose by An Engineered Saccharomyces Cerevisiae Strain

Oct 17, 2011

Eun Joong Oh

Xylitol is a five-carbon sugar alcohol and has been used as a sugar substitute in the food industry because of its low caloric and anti-carcinogenic characteristics. In addition, xylitol is a building block for a variety of commodity chemicals. Biological routes for producing xylitol from...

Process QbD Case Study: An Integrated PAT Approach for a Dynamic Pharmaceutical Co-Precipitation Process Characterization and Process Design Space Development

Oct 17, 2011

Huiquan Wu

Previously we had explored the concepts of developing an integrated PAT approach to monitor and map the state of a dynamic pharmaceutical co-precipitation process in real time, and to determine the nucleation and growth mechanisms occurred during a pharmaceutical co-precipitation process. The aim...

Metabolic Flux Analysis of Escherichia Coli MG1655 Under Octanoic Acid Stress

Oct 17, 2011

Yanfen Fu

Metabolic engineering has evolved to the point of fulfilling the dream of having our industrial chemicals produced renewably. Carboxylic acids (e.g., short chain fatty acids (SCFAs) such as octanoic acid (C8)) are one such chemical intermediate that can be produced with Escherichia coli engineered...

FDA Perspective On QbD for Analytical Methods

Oct 17, 2011

Elaine Morefield

QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and...

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