May 2012 | AIChE

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May 2012

Quality by Design for DPIs -A Regulatory Perspective

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Inhalation Powders have become an important dosage form in developing products for delivery to the lungs. Since the approval of the first DPI in the...

Scale and Bioreactor Design Translation for Rocking Bag Bioreactors

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Scale and Bioreactor Design Translation for Rocking Bag Bioreactors. The translations of scale and bioreactor designs for disposable rocking bag...

Scaling up Strategy for Continuous Powder Mixing Process

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Scaling up strategy for continuous powder mixing process Yijie Gao, Fernando Muzzio and Marianthi G. Ierapetritou Dept. of Chemical and Biochemical...

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

Conference Presentation
AIChE Annual Meeting
October 17, 2011
Previously we had explored the concepts of developing an integrated PAT approach to monitor and map the state of a dynamic pharmaceutical co-...

New Model-Based Platform for Enhanced Content Uniformity Prediction of Oral Dosage Forms

Conference Presentation
AIChE Annual Meeting
October 19, 2011
New Model-based Platform for Enhanced Content Uniformity Prediction of Oral Dosage Forms Being a critical quality attribute for capsules and tablets...

Challenges and Opportunities for Process Systems Engineering Approaches to QbD and Design Space

Conference Presentation
AIChE Annual Meeting
October 16, 2011
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...

CMC Reviewer Expectations for ANDAs Using QbD Approaches

Conference Presentation
AIChE Annual Meeting
October 18, 2011
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...

Use of Single-Use Technologies In Downstream Purification of Mabs - A Case Study

Conference Presentation
AIChE Annual Meeting
October 19, 2011
The employment of single-use technologies in the downstream processing of biologics in general and monoclonal antibodies in particular is gaining...

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

Conference Presentation
AIChE Annual Meeting
October 18, 2011
Multivariate data analysis has recently emerged as a critical tool to gain fundamental understandings of process characteristics, and thus assisting...

QbD In Dry Powder Inhaler Development

Conference Presentation
AIChE Annual Meeting
October 19, 2011
Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example...

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