Pharmaceutical Engineering & Drug Delivery

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...

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...

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...

Out of all the pharmaceutical dosage forms, the Quality Target Product Profile (QTPP) for the sterile dosage form is the strictest for obvious reasons. One has to pay attention to the critical quality attributes (CQA) to a great extent. This presentation is focused only on the packaging of sterile...

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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-...

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...

The key components of the QbD concept, namely, the Design Space and PAT, do draw extensively for their realization on tools from the domain of process systems engineering methodology. Both the challenges and the opportunities in adapting core PSE methodology, such as process modeling and simulation...

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...

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...