Early detection of viruses and mycoplasma prevents cross-contamination, protects the facility, and safeguards product integrity. Accordingly, regulatory agencies require comprehensive virus and mycoplasma monitoring as part of lot release testing. Companies commonly apply three types of testing: IVV, MVM, and mycoplasma.
Not all CDMOs are suitably equipped to handle aseptic processing and sterile fill/finish operations on both a clinical and a commercial scale. Samsung Biologics excels by offering robust safety measures and global reach, driven by continuous investment in initiatives that facilitate high product quality at greater speed and with more process flexibility.
More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards. Samsung Biologics answers some important quality-related questions regarding biopharmaceutical manufacturing.
Samsung Biologics is a reliable partner for seamless tech transfers, clinical and commercial manufacturing, aseptic fill/finish, and analytical testing. Committed to partnership, you will have a dedicated project management team walking you through your product’s entire development and manufacturing journey. We are committed to operational excellence in cGMP manufacturing and quality assurance.