Pharmaceutical Engineering & Drug Delivery

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...

QUALITY by Design (QBD), Biopharmaceutical Manufacture

Oct 17, 2011
Kurt Brorson
In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a regulatory structure supporting Quality by Design (QbD) for pharmaceuticals and biopharmaceuticals has been described in International Conference on...

Quality by Design for Generic Drugs

Oct 17, 2011
Yingxu Peng
To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current...

Automation and Control of Drug-On-Demand Technology

Oct 16, 2011
Laura Hirshfield
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry. The concept of "mini-manufacturing" of drugs, as opposed to mass production of drugs, has shown promise in this area. We describe one such "mini-...

Using QbD to Asses the Factors That Affect Stability and Packaging

Oct 16, 2011
Stephanie Krogmeier
Packaging is often the last step in drug product (DP) development; however packaging is extremely important in determining the marketability of a product. The ability to predict whether a product can be stored at room temperature early in development can affect how the drug is developed. In order...

Science-Based Stability and Packaging Development Under the Umbrella of QbD

Oct 16, 2011
Rey Chern
Abstract Science-Based Stability and Packaging Development Under The Umbrella of QbD Rey T Chern Global Pharmaceutical Commercialization Merck Sharp & Dohme A systematic approach for characterization of product stability risks, selection of primary packages and utilization of first-principle...

QbD Principles for Packaging Design and Stability: A Regulatory Perspective

Oct 16, 2011
Sharmista Chatterjee
Quality by Design (QbD) is a science and risk based approach for pharmaceutical manufacturing and development. Enhanced product understanding gained from following a QbD based approach, is increasingly being used to select packaging design parameters and to determine optimum storage conditions. The...

QbD - It's Not Just for Breakfast Anymore

Oct 16, 2011
Paul C. Collins
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated, particularly with regard to enhanced understanding of processes and better definition of processing parameters such as CPPs. Design space has become...

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