In order to ensure the properties, potency, concentration, quality, and purity of biopharmaceuticals within the specified standards, drug stability test studies are required. Drug stability test of biopharmaceutical is mainly used to study the stability of biopharmaceutical, that is, to study the law of changes in biopharmaceutical over time under the influence of certain conditions, including but not limited to temperature, humidity, and light. Drug stability test provides the scientific basis for the determination of production, preparation, packaging, storage, transportation conditions, and expiration date of biopharmaceuticals and ensures the safety and effectiveness of clinical use.
Biological drug molecules rely on the strictly complex spatial conformation and specific activity centers to maintain specific physiological functions, The stability of biological drugs can be essentially divided into physical and chemical stabilities, and drug stability tests should be carried out according to the unique specificity. Moreover, chemical stability involves the structural stability of biological drug molecules, and physical stability is the change of the physical state of biological drug molecules, including protein denaturation, aggregation, precipitation, adsorption, etc.
Content and Methods of Stability Studies
At present, there is no single stability test method or parameter that can fully reflect the stability characteristics of biopharmaceuticals. Therefore, appropriate physical chemistry, biochemistry, and immunochemistry techniques should be used to determine the properties of active ingredients (API, active pharmaceutical ingredient). The study should be comprehensive and reasonable, as well as include factors that are easy to change during storage and may affect product quality, safety, and/or effectiveness, such as appearance, physical and chemical properties, protein purity, protein content, biological activity, impurities, sterility, bacterial endotoxin, etc.
In order to ensure the authenticity and reliability of the stability-study results, test methods should be specific, accurate, precise, sensitive. The instruments used in stability studies, such as constant temperature and humidity chambers, need to be strictly checked, calibrated, and regularly monitored. Due to molecular changes caused by deamination, oxidation, sulfonylation, polymerization, or degradation in the storage process, the most suitable techniques include electrophoresis, high-resolution high-performance liquid chromatography, and peptide mapping. In terms of sensitive assays, such as protein purity tests, molecular size heterogeneity analysis methods, charge heterogeneity analysis methods, oxidation/hydrophobicity-based analysis methods, etc., can be used.
Our Biopharmaceutical Stability Testing Services
Creative Proteomics offers stability testing programs according to the ICH guidelines Q1A(R2), Q1B, and Q5c, as well as expanded programs tailored to the client's needs. We employ specific, accurate, precise, and sensitive testing methods and have extensive project management experience in support of biopharmaceutical stability studies.
Biopharmaceutical Stability Testing Methods:
- Protein Sequence
- Peptide Mass Fingerprinting Analysis
- Aggregation Analysis
- Advanced Structure Analysis
- 1-D and 2-D SDS-PAGE Analysis
- Western Blot
- Protein Isoform Analysis(Capillary Isoelectric Focusing)
- Total Protein Quantification
- Glycosylation Analysis
- Protein Modifications Analysis
- High-Performance Liquid Chromatography
- Immunochemistry Techniques
- Spectroscopic Profiles