FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments
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16h ago
The majority of PMCs/PMRs are proceeding according to schedule ..read more
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Evaluating the Partnership between mRNA and LNPs
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16h ago
The LNP success in mRNA vaccines leads to their establishment as a standard in mRNA delivery ..read more
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Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients
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2d ago
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors ..read more
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Increasing mRNA Product Stability with Lyophilization
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2d ago
Developing freeze-drying processes requires patience and deep product and process understanding ..read more
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Navigating Commercial Drug Development Technologies for Formulation Excellence
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2d ago
Lonza Small Molecules is focused on leveraging its technologies and expertise to address solubility challenges and support drug development programs through commercialization ..read more
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Bristol Myers Squibb to Access Cellares' Cell Therapy Manufacturing Platform in New $380 Million CAR-T Cell Therapy Deal
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2d ago
In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb ..read more
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Reducing Variability and Time to Results Using Automated Cell-Based Assays
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2d ago
Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays ..read more
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Navigating an Uncertain Regulatory Environment for mRNA-based Products
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3d ago
Regulations for mRNA products are evolving as the market for mRNA expands ..read more
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INTERPHEX 2024: Implementing Contamination Control Strategies in Cell and Gene Therapy Facilities
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4d ago
A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024 ..read more
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Taking a Deeper Look at Sterile Powder Transfer in Aseptic Fill/Finish of Parenterals (INTERPHEX 2024)
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4d ago
Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products ..read more
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