Biopharmaceutical stability testing from SGS – confirm product stability and help identify possible changes to the potency, function and safety of biopharmaceutical drug substances, in-process materials and products following storage under controlled conditions.
Biopharmaceutical products are highly variable and, relative to pharmaceuticals, generally require more controlled conditions to preserve product potency, function and safety. They have lower handling tolerances to temperature, require more stringent containment methods to avoid contamination and are more susceptible to agitation and vibration. Additionally, biopharmaceuticals tend to be more susceptible to degradation when faced with changes in their chemical environment. These include changes in pH, ionic strength, the presence or absence of metal ions, surfactant type and surfactant concentration.
As a biopharmaceutical company, you need to provide evidence of the stability and quality of your drug substance or drug product throughout its lifecycle, from production through storage and distribution, under both expected and unexpected conditions. ICH, EMA, WHO and FDA guidelines require shelf lives of all drug substances and drug products to be monitored via stability testing.
We offer a wide range of standard and custom studies to monitor biopharmaceutical stability to evaluate and demonstrate material/product potency, and safety. With our purpose built, state-of-the-art laboratories, we can provide stability studies tailored to your project to ensure you gain regulatory approval. Our biopharmaceutical stability studies also support products contained in controlled delivery devices that are components of medical devices.
Study types include:


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Search within Biopharmaceutical Stability Testing and Storage
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines