Process monitoring and quality by design for biotechnology products /
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| Format: | eBook |
| Language: | English |
| Published: |
San Rafael, Calif. (1537 Fourth Street, San Rafael, CA 94901 USA) :
Morgan and Claypool,
[2010]
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| Series: | Colloquium digital library of life sciences.
Colloquium series on biotechnology ; # 1. |
| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Abstract: | 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. |
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| Item Description: | Part of: Colloquium digital library of life sciences. Series from website. Electronic resource. |
| Physical Description: | 1 online resource (ix, 28 pages) : illustrations Also available in printing. |
| Format: | Mode of access: World Wide Web. System requirements: Adobe Acrobat reader. |
| Bibliography: | Includes bibliographical references (pages 27-28). |
| ISBN: | 9781615041152 (electronic bk.) |
| Access: | Abstract freely available; full-text restricted to subscribers or individual document purchasers. |