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
Trusted biopharmaceutical stability testing from a world leading life sciences provider
As a world leading provider of services to the life sciences sector, we provide the largest network of contract testing laboratories. With 29 facilities across 15 countries, we offer clinical research services, analytical development, biologics characterization, utilities qualification, biosafety and quality control testing for leading pharmaceuticals across the world. Our dedicated laboratories are fully cGMP qualified and FDA/MHRA registered and inspected.
Stability indicating methods can be developed, validated and transferred to ICH standards. A range of industry standard analytical equipment is available for effective method transfers. Plus, a full range of pharmacopeial and high throughput analytical methods are available for routine analysis of protein stability, as well as complex analytical testing. In addition to pharmacopeial methods, the following analytical services are also available:
- Aseptic aliquoting
- Sample tracking and inventory control
- Imaged capillary IEF (icIEF) and agarose gel IEF
- SDS-PAGE
- Capillary gel electrophoresis (CGE)
- HPLC and UPLC (SEC/RP/IEX/HIC)
- SEC-MALS
- Protein concentration
- Peptide mapping with UV, MS and/or MS/MS and/or MSe analysis
- Intact mass MS (MALDI-TOF and ESI-MS)
- Analytical ultracentrifugation (AUC)
- Dynamic light scattering (DLS)
- Circular dichroism (CD)
- Differential scanning calorimetry (DSC)
- Fourier transform infrared spectroscopy (FTIR)
- Extrinsic and intrinsic fluorescence
- Bioassays/BIAcore
- Glycan profiling (neutral glycans and sialic acids)
To find out more about our biopharmaceutical stability testing services, contact us today.
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