An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies
| Autor: | Peter M. Ihnat, Katherine Taylor, Chakravarthy Nachu Narasimhan, Dingjiang Liu, Valentyn Antochshuk, Jason E. Fernandez, Kapil Gupta, Daniel Dix, Eric Routhier, Elaine S.E. Stokes, Truong Nobel T, Sorina Morar-Mitrica, Fleming Michael, James K. Kranz, Diluzio Willow, Christine Wurth, George Crotts, Bing He, Monica L. Adams, Tanvir Tabish |
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| Rok vydání: | 2017 |
| Předmět: |
0106 biological sciences
0301 basic medicine Process management Drug Industry Computer science Best practice Chemistry Pharmaceutical Pharmaceutical Science 01 natural sciences Risk Assessment Quality by Design Biopharmaceutics 03 medical and health sciences Robustness (computer science) 010608 biotechnology Critical to quality Humans Technology Pharmaceutical Good manufacturing practice Intersectoral Collaboration Clinical Trials as Topic Design of experiments 030104 developmental biology Biopharmaceutical Pharmaceutical Preparations Drug Design Drug product |
| Zdroj: | Journal of pharmaceutical sciences. 107(2) |
| ISSN: | 1520-6017 |
| Popis: | The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices. |
| Databáze: | OpenAIRE |
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