Characterization of Degradation Products in Biologics
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Stability Testing for Biopharmaceuticals
pH Sensitivity and Its Role in Biologic Drug Stability
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Use of Mass Spectrometry in Biologic Stability Testing
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Surfactants in Biologics: Enhancing Product Stability
Biologic products, unlike small-molecule drugs, have large and complex structures. This makes them susceptible to instability under conditions such as:
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Lyophilized vs Liquid Biologics: Stability Considerations
Biologics can be formulated in two primary ways:
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Container Closure Integrity in Biologic Stability
Biologic formulations, especially those in liquid or reconstituted form, require sterile barriers to maintain their potency and safety. A breach in the container closure system can result in:
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Stability Testing During Biologic Tech Transfer
Biologic products are particularly sensitive to manufacturing and environmental variations. Even minor changes in formulation, scale, or equipment can affect stability. Stability testing during tech transfer ensures:
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Host Cell Protein Impurities and Biologic Stability
HCPs are proteins derived from the host expression system—most commonly Chinese Hamster Ovary (CHO) cells, E. coli, or yeast. These proteins are co-purified with the therapeutic protein and can vary in type and quantity across batches. Their presence poses risks including:
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Aggregation Pathways and Biologic Stability Challenges
Aggregation refers to the formation of dimers, oligomers, or larger aggregates of protein molecules due to structural instability. It can occur through various pathways and under different stress conditions, including thermal stress, mechanical agitation, freeze-thaw cycles, and changes in pH or ionic strength. Aggregates can be reversible or irreversible and are categorized based on their size:
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Analytical Methods to Detect Instability in Biologics
Unlike small-molecule drugs, biologics such as monoclonal antibodies, enzymes, and vaccines are sensitive to:
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