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Biological Drug Stability Analysis

Biopharmaceutical stability analysis aims to determine the degree of change in the chemical, physical, microbiological, and biological properties of biopharmaceuticals under specific storage conditions and time. Studying the stability of biopharmaceuticals is crucial for evaluating the sensitivity to factors that may lead to drug aggregation and degradation. These factors can affect the biological activity of the drug, the safety of the product, and its quality. Environmental factors (such as temperature, oxygen exposure, or pH changes), surface adsorption, and interactions with excipients can all impact drug stability. Changes in the stability of biopharmaceuticals can alter protein folding and the three-dimensional structure of proteins, thereby affecting drug efficacy. Accurately assessing the stability of drugs under various environmental factors helps predict and control potential changes, providing key support for drug development, production, storage, and clinical applications. Moreover, stability analysis is also an important step in drug registration and marketing, having profound significance for the sustainable and healthy development of the biopharmaceutical industry.

BTP (Biotechnology) has obtained dual quality system certification from CNAS/ISO9001, established seven major testing platforms, and developed and validated methods for biopharmaceutical stability analysis, providing you with various types of biopharmaceutical stability analysis, including proteins, monoclonal antibodies, vaccines, PEGylated proteins, oligonucleotides, glycoproteins, and biosimilars. We evaluate drug accelerated stability, short-term, and long-term stability through physicochemical properties, structure, aggregation, biological activity, visual appearance, impurities, etc. Feel free to consult us for more details!

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