Biologics Manufacturing
GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
IDT Biologika
Biologics Manufacturing
Safety, quality and efficacy of biologics through advanced viral contamination testing.
This white paper provides knowledge on Adventitious Virus Testing, covering regulatory authorities, Next Generation Sequencing, bioinformatics and computer system validation.
This white paper provides knowledge on Adventitious Virus Testing, covering regulatory authorities, Next Generation Sequencing, bioinformatics and computer system validation.
Regulatory Context
Authorities increasingly accept NGS as a broad-spectrum alternative to traditional assays.
NGS and Bioinformatics
Sequencing combined with validated analysis pipelines detects a wide range of potential contaminants.
Computer System Validation
GMP use requires validated software and documented data handling.
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