Process Monitoring and Quality by Design for Biotechnology Products

Process Monitoring and Quality by Design for Biotechnology Products

Neslihan Delacruz
ISBN: 9781615041145 | PDF ISBN: 9781615041152
Copyright © 2010 | 38 Pages | Publication Date: 01/01/2010

BEFORE YOU ORDER: You may have Academic or Corporate access to this title. Click here to find out: 10.4199/C00019ED1V01Y201011BTY001

Ordering Options: Paperback $30.00   E-book $24.00   Paperback & E-book Combo $37.50


Why pay full price? Members receive 15% off all orders.
Learn More Here

Read Our Digital Content License Agreement (pop-up)

Purchasing Options:



Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use.

Table of Contents

Abbreviations
Introduction
From the Traditional Development Path to Quality by Design
Continuous Process Verification and Process Monitoring
Process Monitoring and Statistical Control Limits
Multivariate Analysis: A Mature State of Statistical Process Monitoring
Conclusion
Bibliography

About the Author(s)

Neslihan Delacruz

Reviews
Browse by Subject
Case Studies in Engineering
ACM Books
IOP Concise Physics
SEM Books
0 items
LATEST NEWS

Newsletter
Note: Registered customers go to: Your Account to subscribe.

E-Mail Address:

Your Name: