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Society for Biological Engineering (SBE)

SBE is a global technological community that promotes the integration of engineering with biology and realize its benefits through bioprocessing, biomedical, and biomolecular applications. SBE provides opportunities for interaction of engineers and scientists, develops products and services bring value to the broad biological engineering community, and infuses awareness of biological engineering among all functions and activities of AIChE.

Forest Bioproducts Division (FBP)

The Forest Bioproducts Division promotes knowledge sharing and networking on topics dealing with products obtained from forest resources and other lignocellulosic materials.

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Toward a More Reliable USP Dissolution Testing Apparatus II

Nov 7, 2010
Yimin Wang
In the pharmaceutical industry, dissolution testing is a critical step in quality control and a standard method for assessing batch-to-batch consistency of solid oral drug delivery systems, such as tablets. One of the most widely used dissolution test devices is the UPS Apparatus II (paddle). Even...

QbD in Generic Drug Development: PAT Application

Nov 7, 2010
Salah U. Ahmed, Yanming Zu
A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements for identity, purity, quality, stability, and complies with the same rigid standards of GMP regulations for manufacturing as the innovator product. In...

Quality by Design for Generic Drugs: Overview

Nov 7, 2010
Robert A. Lionberger
Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about how the core concepts in ICH Q8(R1) will apply to development of generic drugs. FDA's Office of Generic Drugs has been revising its approaches to...

Quality by Design in Pharmaceutical Development

Nov 7, 2010
Yatindra Joshi
More than 70% of the prescriptions in the US are now filled with generic products, and therefore, the industry has the responsibility to continue to provide safe, effective, and affordable medications. In 2009 GPhA initiated a dialogue between the Industry and the US FDA Office of Generics on...

Using Qualitative Models to Capture and Demonstrate Process Understanding

Nov 7, 2010
Ian Houson
This presentation will cover how qualitative models can be used to capture and demonstrate process understanding and improve communication between disciplines, across geographical locations, languages and cultures both within, and between, organisations and regulators within a QbD framework. The...

Feed-Forward Process Control Strategy for Pharmaceutical Tablet Development

Nov 11, 2009
Koji Muteki
A feed-forward process control strategy which can compensate for the effect of raw material lot-to-lot variability on final tablet attributes in pharmaceutical tablet development is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and...

Growth Kinetic Study of Chlorella Vulgaris

Nov 11, 2009
Jinsoo Kim
Algae are simple autotrophic organisms that produce complex organic compounds from simple inorganic molecules such as carbon dioxide using energy from light or inorganic chemical reactions. These complex organics include a substantial amount of triacylglycerol which can be readily converted into...

Application of Modeling to Scale-up Liquid Mixing Processes

Nov 11, 2009
Venkat R. Koganti
Scale-up of liquid mixing is usually done empirically without considering the several factors like dissolution theory, equipment differences between scales and so on. In this work we present a systematic way to scale-up liquid mixing processes utilizing both Design of Experiment (DoE) approach to...

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