Pharmaceutical Engineering & Drug Delivery

Quality by Design for Generic Drugs

Conference Presentation
AIChE Annual Meeting
October 17, 2011
To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed...

Building a Better Biofuel Production Platform

Conference Presentation
AIChE Annual Meeting
October 17, 2011
Building a Better Biofuel Production Platform: Engineering metabolic control techniques to control the photosynthetic cyanobacterium Synechocystis sp...

Automation and Control of Drug-On-Demand Technology

Conference Presentation
AIChE Annual Meeting
October 16, 2011
After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry...

QbD - It's Not Just for Breakfast Anymore

Conference Presentation
AIChE Annual Meeting
October 16, 2011
We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated...

Microengineered Hydrogels for Stem Cell Bioengineering and Tissue Regeneration

Archived Webinar
Aug 23, 2011
Micro- and nanoscale technologies are emerging as powerful tools for controlling the interaction between cells and their surroundings for biological studies, tissue engineering, and cell-based screening. In addition, hydrogel biomaterials have been increasingly used in various tissue engineering...

Mixture DOE and Design Space

Conference Presentation
AIChE Annual Meeting
November 10, 2010
Present a case study on mixture DOE involving five components used to formulate a pharmaceutical tablet. The goal is to achieve a sustained release...

QbD for Generic Drugs: Modified Release Drug Products

Conference Presentation
AIChE Annual Meeting
November 7, 2010
The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug product pharmaceuticals. This is based principally upon a...

QbD for Generic Drugs: Oral Suspensions

Conference Presentation
AIChE Annual Meeting
November 7, 2010
The presentation will be focus on the approach for systematic development of oral suspensions. Suspension is a complex dosage form in which coarse...

QbD in Generic Drug Development: PAT Application

Conference Presentation
AIChE Annual Meeting
November 7, 2010
A generic drug product is pharmaceutically and therapeutically equivalent to a Reference Listed Drug (RLD) product. It meets the same requirements...

Quality by Design for Generic Drugs: Overview

Conference Presentation
AIChE Annual Meeting
November 7, 2010
Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about...

Application of QbD Principles to Analytical Methods

Conference Presentation
AIChE Annual Meeting
November 8, 2009
The same QbD Principles applied to the design of manufacturing processes are applicable to the design of analytical methodology. QbD elements such as...

Update on QbD Implementation: An FDA Perspective

Conference Presentation
AIChE Annual Meeting
November 8, 2009
Quality by Design (QbD) is a science and risk based approach for pharmaceutical process development and manufacturing that begins with first defining...

There’s Plenty of Room at the Bottom of a Cell

October
2017
SBE Special Section
Angela R. Wu, Lei Yu
Single-cell RNA sequencing is giving engineers and scientists the ability to better understand and manipulate the smallest unit of a living organism — the single cell. This technique has already ushered in breakthroughs in biology and medicine. However, challenges and opportunities abound.

SBE Special Section: Biomolecular Engineering (full 34-page section)

October
2017
SBE Special Section
SBE Update: The Many Applications of Biomolecular Engineering; A Materials Approach to Vaccines as Therapies; Engineering Cancer-Fighting T Cells; There's Plenty of Room at the Botton of a Cell; Computational Protein Engineering; Plant Metabolic Engineering for Chemicals, Fuels, and Precursors

A Materials Approach to Vaccines as Therapies

October
2017
SBE Special Section
Neil Dold, Christopher M. Jewell
The widespread adoption of vaccines over the last two centuries has transformed medicine by preventing infectious disease. In the future, so-called therapeutic vaccines could be used as effective treatments for cancer and autoimmune disorders — ushering in a new era of medicine.

Engineering Cancer-Fighting T Cells

October
2017
SBE Special Section
Eugenia Zah, Yvonne Y. Chen
Adoptive T-cell therapy is a personalized cancer treatment that has the potential to cure previously untreatable malignancies. Researchers are applying techniques in biomolecular engineering and synthetic biology to the development of next-generation therapeutic T cells with improved safety and efficacy against a variety of cancers.

FDA Perspective On QbD for Analytical Methods

Conference Presentation
AIChE Annual Meeting
October 17, 2011
QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to...

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