Lyophilized Drug Product Cake Appearance: What Is Acceptable?

2017/03/22 by Sajal Manubhai Patel, Sajal M. Patel, Steven L. Nail +6 · 25 citations
Biochemistry, Genetics and Molecular Biology · Materials Science · Agricultural and Biological Sciences · #Protein purification and stability #Crystallization and Solubility Studies #Microencapsulation and Drying Processes

paper · doi:10.1016/j.xphs.2017.03.014

Cited by

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• Image-Based Artificial Intelligence Methods for Product Control of Tablet Coating Quality. [europepmc]
• Simple Method to Measure the Aerodynamic Size Distribution of Porous Particles Generated on Lyophilizate for Dry Powder Inhalation. [europepmc]
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• Nanoencapsulation as a General Solution for Lyophilization of Labile Substrates. [europepmc]
• Shelf-Life Extension of Fc-Fused Single Chain Fragment Variable Antibodies by Lyophilization. [europepmc]
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• Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine. [europepmc]
• Model-Based Product Temperature and Endpoint Determination in Primary Drying of Lyophilization Processes. [europepmc]
• Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics. [europepmc]
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• Development of a Ready-to-Use-Type RNA Vaccine Carrier Based on an Intracellular Environment-Responsive Lipid-like Material with Immune-Activating Vitamin E Scaffolds. [europepmc]
• Lyophilized monkeypox mRNA lipid nanoparticle vaccines with long-term stability and robust immune responses in mice. [europepmc]
• Freeze-Drying of mRNA-LNPs Vaccines: A Review. [europepmc]