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.
Why choose biopharmaceutical stability testing from SGS?
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:
- Forced degradation assessments according to ICH Q5C and ICH Q1B
- Long term drug stability studies
- Accelerated stability studies
- Shelf life assessments
- In-use studies
- Short term temperature excursion studies
- Shipping studies
We can help you:
- Design studies to suit your needs and satisfy regulators
- Provide evidence on how the quality of your drug substance or drug product varies with time
- Prove the stability and quality of your drugs under the influence of a range of environmental factors, such as temperature and light
- Establish a re-test period for your drug substance and or intermediates
- Determine a shelf life for your drug product and recommended storage conditions
- Gain tailored reporting with full data interpretation by experienced personnel or standard results data tables. Live data trending will be performed with routine updates for the duration of each study
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