Viral Clearance: Safety and Efficiency of Biopharmaceuticals.
Viral clearance is a vital procedure in the pharma industry, safeguarding the well-being of drug products by eradicating or inactivating possible viral toxins while manufacturing. This includes a multifaceted method, along with laborious testing of raw materials, process design, optimization, and va...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 60; no. 3; pp. 663 - 674 |
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| Autores principales: | , , , |
| Formato: | pictorial review tables/charts Journal Article |
| Publicado: |
Springer Nature
May2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=193278366&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 193278366 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21684790 FUHO jtl: Therapeutic Innovation & Regulatory Science issn: 21684790 maglogo: N pubinfo: dt: May2026 vid: 60 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 193278366 191511331 193278366 193278366 10.1007/s43441-026-00922-2 193278366 ppf: 663 ppct: 11 formats: tig: atl: Viral Clearance: Safety and Efficiency of Biopharmaceuticals. aug: au: Vahora, Shahin Patel, Bhavesh Talati, Nishant Morker, Krupalkumar affil: Navinta LLC, 1499 Lower Ferry Road, 08618, Ewing, NJ, USA sug: subj: Drug Contamination Risk Factors Biological Products Analysis Patient Safety Evaluation Drug Efficacy Evaluation Viruses Drug Compounding Risk Assessment Drug Contamination Prevention and Control Legislation, Drug Chemistry, Pharmaceutical Pharmaceutical Companies Government Regulations Hydrogen-Ion Concentration Solvents Detergents Heating Chromatography Chemical Precipitation ab: Viral clearance is a vital procedure in the pharma industry, safeguarding the well-being of drug products by eradicating or inactivating possible viral toxins while manufacturing. This includes a multifaceted method, along with laborious testing of raw materials, process design, optimization, and validation studies to demonstrate the effectiveness of viral clearance steps. Nowadays, this topic has become more challenging and versatile with the development of new viruses in the environment. This manuscript focuses on the potential routes of viral contamination, including viral impurities present in the master cell bank, and contaminated virus introduced during manufacturing, adventitious viruses from raw materials, principles of viral clearance, regulatory framework, design of viral clearance studies interpretation and limitations, emerging technologies and trends, viral clearance strategies such as inactivation methods: low pH, solvent/detergent, heat treatment and removal methods like chromatography, nanofiltration, precipitation and related case studies. pubtype: Academic Journal doctype: pictorial review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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