Life Sciences Formulation Development of Biologics
Formulation development of biologics from SGS – helping you select the correct formulation for your drug product to ensure a commercially viable shelf life.
To ensure a long product shelf life and appropriate formulation for your chosen route of administration, generating a stable environment for your biopharmaceutical drug products is essential. To help you, we offer formulation development tailored to your precise needs. With our purpose built, state-of-the-art laboratories, we provide a comprehensive range of services. These include fully comprehensive studies, preformulation testing, stress testing, lyophilization cycle development optimization, critical quality attribute assessment, protein formulation development and risk-based reduced scale studies.
Why choose formulation development of biologics from SGS?
We can help you:
- Ensure a commercially viable product shelf life
- Evaluate potential degradation pathways and identify stability indicating methods
- Assess critical quality attributes (CQAs), including conformational changes. Our stability-indicating methods can be developed and subsequently transferred
- Evaluate conformational and structural changes using an array of higher order structure biophysical techniques
- Generate a stable environment for your drug products
Trusted formulation development of biologics from a world-leading life sciences provider
As a leader in biopharmaceutical characterization for 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. Plus, for peace of mind, all formulations are developed with regulatory approved excipients, which target specific degradation pathways and protect CQAs.
A full range of high throughput analytical methods are available for fast turnaround, low protein consumption. Plus, our extensive characterization experience ensures lead candidates can also be fully characterized, so you can be fully confident in the final, selected formulation.
In addition to pharmacopeial methods, the following analytical services are also available:
- Low-volume light obscuration particle analysis
- Imaged Capillary IEF (icIEF) and Agarose Gel IEF
- Capillary Gel Electrophoresis (CGE)
- UV, vis, florescence high throughput and low volume plate reader
- UPLC and HPLC (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 discuss how our formulation development of biologics services can help you, contact us today.