As a biopharmaceutical company, you need to provide evidence of the stability and quality of your drug substance or drug product under a variety of conditions. ICH, EMA, WHO and FDA guidelines require the monitoring of shelf-life by performing stability studies on all drug substances and drug products.
We offer a wide range of studies to monitor drug stability. This includes long-term drug stability and accelerated stability studies, shelf-life assessment, in-use studies, short-term temperature excursion studies, and forced degradation assessments according to ICH Q5C and ICH Q1B. With our purpose built, state-of-the-art laboratories, we offer stability studies tailored to your project to ensure you gain regulatory approval.
Why choose stability studies for biopharmaceuticals from SGS?
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, humidity 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 Stability Studies for Biologics 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 aliquotting
- Sample tracking and inventory control
- Imaged Capillary IEF (icIEF) and Agarose Gel IEF
- Capillary Gel Electrophoresis (CGE)
- HPLC and UPLC (SEC/RP/IEX/HIC)
- 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 stability studies for biologics, contact us today.