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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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Microreactor for Industrial Application: Technical and Economical Benefits

Nov 8, 2010
Sergio Pissavini
A glass based high throughput microreactor technology is presented illustrating the basic design window, technical data and configuration. An overview of some class of reactions performance is provided as compared to batch process. For three typical reaction a comparison between typical plant...

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...

Design and Construction of a Protein Degradation Switch

Nov 7, 2010
S. Marjan Varedi K.
Targeted protein degradation in eukaryotic cells requires recruitment of the target protein to proteasome which is usually triggered by ubiquitination of the target protein. It has recently been shown that ubiquitination is not necessary and localization to the proteasome is sufficient for...

QbD for Generic Drugs: Modified Release Drug Products

Nov 7, 2010
Andre Raw
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug product pharmaceuticals. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among...

Modeling Eukaryotic Unfolded Protein Response and Its Role in Cellular Stress

Nov 7, 2010
Anirikh Chakrabarti
Malfunctions in the folding state of critical proteins have been linked with cancer, diabetes and other diseases. Proteins requiring complex post-translational modification are processed in the Endoplasmic Reticulum (ER). Cells monitor protein folding by an inbuilt quality-control system involving...

QbD for Generic Drugs: A Case Study for Immediate-Release Products

Nov 7, 2010
Zhigang Sun
Quality by design (QbD) is a systematic approach for product and process design and development to ensure predefined product quality. Although the recent ICH guidelines (Q8-Q10) have provided an outline for development of “high quality” pharmaceutical products based on a comprehensive QbD approach...

Model-Driven Minimization of the B. Subtilis Genome

Nov 7, 2010
Christopher Henry
Bacillus subtilis is a gram positive, sporulating bacteria often utilized in industry as a producer of high quality enzymes and proteins [1]. The flexible growth conditions, rapid growth rate, and natural competence of B. subtilis make it an ideal candidate for scientific study and industrial use...

Novel, Synthetic, Tetracycline-Inducible Transcription Regulators for E. Coli

Nov 7, 2010
Katherine G. Volzing
We are designing, constructing and characterizing novel synthetic gene regulators. These regulators range from individual inducible fusion protein and promoter pairs to complex nonlinear regulatory networks. All of the regulators are designed to be compatible in E. coli and to control gene...

QbD for Generic Drugs: Oral Suspensions

Nov 7, 2010
Umesh Pai
The presentation will be focus on the approach for systematic development of oral suspensions. Suspension is a complex dosage form in which coarse dispersion in which insoluble solid particles (internal phase) is dispersed uniformly throughout the suspending medium (external phase). Strategies for...

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...

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