Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing

Author:

ITO TakaoORCID,Wang HuiORCID,Hwang Soon-Hwa,Wang Bin,Wang LizhiORCID,G Somasundaram

Funder

Merck KGaA

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference51 articles.

1. Single-use technologies in biopharmaceutical manufacturing: a 10-year review of trends;Langer;Eng Life Sci,2014

2. Single-use in the biopharmaceutical industry: a review of current technology impact, challenges and limitations;Lopes;Food Bioprocess Technol,2015

3. Industrialization of mAb production technology: the bioprocessing industry at a crossroads;Kelly;mAbs,2009

4. Single-use disposable technologies for biopharmaceutical manufacturing;Shukla;Trends Biotechnol,2013

5. The single-use or stainless steel decision process;Rogge;Bioprocess Int,2015

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