Risk Assessment Approach to Microbiological Controls of Cell Therapies.

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作者： Tony,Cundell ^[1] ; Scott,Drummond ^[2] ; Irving,Ford ^[3] ; Dona,Reber ^[4] ; Donald,Singer ^[5] ; members of the Pharmaceutical Microbiology Expert Discussion Group

作者单位： Microbiological Consulting LLC, Scarsdale, NY; tonycundell@gmail.com. ^[1] Johnson & Johnson Companies, NB, NJ. ^[2] Celgene Corporation, Summit, NJ. ^[3] Pfizer, Collegeville, PA; and. ^[4] New Beginnings Microbiology, Phoenixville, PA. ^[5]

关键词 Adventitious viruses Bacterial endotoxin Biological safety cabinets Cell collection Cell therapies Cell transformation and expansion Donor selection In-process sterility testing Isolator systems Microbial contamination Mycoplasma Rapid microbial detection testing Restrictive access barrier systems Risk-based approach Sterility

主题词药物污染(Drug Contamination);药物包装(Drug Packaging);人类(Humans);危险性评估(Risk Assessment);工艺学, 制药(Technology, Pharmaceutical)

DOI 10.5731/pdajpst.2019.010546

PMID 31941793

发布时间 2021-01-27

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PDA journal of pharmaceutical science and technology

229-248页

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Risk Assessment Approach to Microbiological Controls of Cell Therapies.

PDA journal of pharmaceutical science and technology

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Risk Assessment Approach to Microbiological Controls of Cell Therapies.

PDA journal of pharmaceutical science and technology

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PDA journal of pharmaceutical science and technology

相关期刊

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