| | | | | | | | The CGT manufacturing recommendations are meant to provide potency assurance considerations at every stage of development and commercialization. |
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| | | | | The acquisition would expand Samsung’s CDMO capabilities into peptide manufacturing, with completion now expected by late 2026 or early 2027. |
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| Bids are being accepted through December 15 for the facility, viral vector manufacturing, equipment, and related intellectual property. |
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| | | | Sponsored | | Pharmaceutical manufacturers must ensure data integrity across production, quality control, and quality assurance. By integrating MES, LIMS, and eQMS, organizations can eliminate data silos, strengthen ALCOA+ compliance, and enable end-to-end traceability. This connected approach improves data visibility, supports regulatory readiness, accelerates decision-making, and drives more efficient and reliable operations. |
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| | | | Sponsored | | Get a glimpse of our on-demand webinar, where we discuss the latest updates to Ph. Eur. 2.6.7 (12.2) and USP <77> and what they mean for NAT-based mycoplasma testing. Learn how a validated workflow combining nucleic acid extraction and real-time RT-PCR supports rapid, reliable, and compliant mycoplasma detection for cell therapy products. |
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| | | | Sponsored | | This presentation addresses key considerations for developing and validating ADC-specific analytical methods, including DAR distribution, free payload, conjugational heterogeneity, product-related impurities and functional potency. |
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