Quality by Design for Biopharmaceutical Drug Product - download pdf or read online


By Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe

ISBN-10: 1493923153

ISBN-13: 9781493923151

ISBN-10: 1493923161

ISBN-13: 9781493923168

This quantity explores the applying of caliber via layout (QbD) to biopharmaceutical drug product improvement. Twenty-eight complete chapters conceal dosage types, liquid and lyophilized drug items. The introductory chapters of this publication outline key components of QbD and think about how those components are built-in into drug product improvement. those chapters additionally speak about classes discovered from the FDA place of work of Biotechnology items pilot application. Following chapters exhibit how QbD is used for formula improvement starting from screening of formulations to developability evaluation to improvement of lyophilized and liquid codecs. the following few chapters research using small-scale and surrogate types in addition to QbD program to drug product procedures equivalent to drug substance freezing and thawing, blending, sterile filtration, filling, lyophilization, inspection and delivery and handling.

Later chapters describe extra really good functions of QbD within the drug product realm. This comprises using QbD in basic boxes, units and blend product improvement. the amount additionally explores QbD utilized to vaccine improvement, automation, mathematical modeling and tracking, and controlling strategies and defining regulate recommendations. It concludes with a dialogue at the program of QbD to drug product expertise move in addition to total regulatory concerns and lifecycle administration. Quality via layout for Biopharmaceutical Drug Product improvement is an authoritative source for scientists and researchers attracted to increasing their wisdom on QbD rules and makes use of in growing higher drugs.

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Additional info for Quality by Design for Biopharmaceutical Drug Product Development

Sample text

2 Interpretation/Consideration for Biopharmaceuticals The QTPP defines a target for product quality requirements. It forms the basis for the development of other key QbD elements, such as CQAs and control strategy, and drives formulation and process development decisions. The QTPP describes the product design criteria that will ensure the quality, safety, and efficacy of a specific product for patients. A series of critical considerations should be made for the QTPP of a biopharmaceutical product.

In addition to the inclusion of full reports and summary narratives, it will be helpful to include tables or figures that summarize findings and the proposed control strategy. 1) may be helpful. At a higher level, summaries of the control elements used for each quality attribute in the drug substance or drug product processes could be provided. ICH Q11 includes an example of a possible control strategy summary table (example 5a) for biotechnology products. 8 Conclusion Preliminary findings from the OBP QbD pilot program indicated that application of the enhanced QbD concepts to both the drug substance and drug product could result in a significant increase in product and process understanding.

22528 Roy ML, Pikal MJ (1989) Process-control in freeze-drying—determination of the end-point of sublimation drying by an electronic moisture sensor. J Parenter Sci Technol 43:60–66 Roychoudhury P, O’Kennedy R, McNeil B, Harvey LM (2007) Multiplexing fibre optic near infrared (NIR) spectroscopy as an emerging technology to monitor industrial bioprocesses. Anal Chim Acta 590:110–117. 011 Schwegman JJ, Carpenter JF, Nail, SL (2007) Infrared microscopy for in situ measurement of protein secondary structure during freezing and freeze-drying.

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Quality by Design for Biopharmaceutical Drug Product Development by Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe

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