Whitepaper
Process Development for Lyophilized Products
Resource Overview
The process development for product lyophilization includes a number of critical stages, such as freezing, primary drying, and secondary drying. This whitepaper outlines strategies for enhancing efficiency and stability in the lyophilization cycle while also addressing the management of residual moisture to ensure product quality.
In this whitepaper learn more from the Simtra BioPharma Solutions team on the approach to process development for lyophilized products conducted at Simtra.
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Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
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Vial Breakage During Lyophilization
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Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility
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Bringing your Sterile Injectable Product to Market: Considerations for Collaborating with a Fill/Finish CMO
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Whitepaper
Is Mannitol Hemihydrate Detrimental to Protein Stability?
Maintaining an amorphous excipient matrix is crucial for protein stability in freeze-dried pharmaceuticals. The high propensity to crystallize during freezing and its high eutectic temperature make mannitol an attractive bulking agent in lyophilized pharmaceuticals. However, mannitol, a widely used excipient, can form a metastable polymorph called mannitol hemihydrate (MHH) during freeze-drying, potentially impacting protein stability....
Whitepaper
Solid State Hydrogen Deuterium Exchange to Study Antibody-Drug Conjugate Stability
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Whitepaper
Factors to Consider While Selecting Stoppers for Lyophilized Vials
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Whitepaper
Best Practices in Formulation and Lyophilization Development
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Methods for Determining Equipment Capability of Freeze-Dryers
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Leak Rate Testing for Freeze-Dryers
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Stopper Migration in Frozen Pre-Filled Syringes
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Scale-Up and Tech Transfer
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Vial Fogging: Practical Considerations for Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products, characterized by a haze of dried powder forming above the cake’s surface inside the vial. This haze can appear as a dendritic pattern, branching, or a uniform fog. While often considered a cosmetic defect, severe fogging can lead to the costly rejection of...
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Lyophilization Development for Antibody-Drug Conjugates (ADCs)
With their ability to deliver precisely targeted therapies for a growing number of cancer types, it’s no wonder that the development and approval of ADCs is expanding, with 17 now approved worldwide and more than 100 in development. Because the antibody is generally less stable than the small-molecule cytotoxic agent, 90% of commercially available ADCs...