High quality protein analytics are essential for biopharmaceutical manufacturing. ProBioGen has established a broad spectrum of analytical methods which are an integral part of our service spectrum. With our bioanalytical characterizations we can add substantial value to your product by simplifying decisions regarding lead selection and conducting assays that are mandatory by regulatory bodies.
The analysis of glycosylation patterns, the determination of potency and the consistency of immunological properties support the right choice for your final clone or product candidate. As a passionate mammalian cell specialist, we have developed a number of complex cell-based assays, such as for antibody-dependent cellular cytotoxicity (ADCC), anti-viral assays for interferons, proliferation and anti-proliferation assays, and many others.
Our proprietary Human Artificial Lymph Node technology enables the prediction of human immune responses, triggered by drug candidates in a complex in vitro system.
Additionally, continuously improved physico-chemical methods assessing the integrity, identity, purity and content of a product together with a variety of specific biochemical and immunological assays are routinely performed. These bioassays and analytical methods can be established and validated at ProBioGen according to international guidelines using sophisticated statistical methods (DoE, QbD) in an ISO9001- and GMP-certified environment.
Biochemical and physico-chemical analyses
At ProBioGen we offer continuously improved biochemical and physico-chemical analyses within an independent Quality Control department. External analyses are managed by experienced QC project managers.
Typical product characterization techniques include:
- Gel electrophoretic techniques: SDS-, Native-PAGE, IEF with Western Blot-, Coomassie-, Silver-staining (reduced, non-reduced)
- Chromatographic methods: SE-HPLC, RP-HPLC, AEX, CEX, AC, Glycan Profiling , N-Terminal Sequencing
- Immuno assays: Product specific ELISAs; ELISAs for impurity determination: e. g. HCP, Protein A
- Biochemical assays: R-DNA (Picogreen), Thiol-assay (product characterization)
- Spectrometric methods: UV (content, purity, stability), FT-IR (identity, stability), Mass (PMF, Deamidation, Oxidation, Post-Translational Modifications, Residual solvents)
- Binding assays: Ligand Binding assays, Surface Plasmon Resonance (e. g. Biacore)
- Pharmaceutical-technological methods: Color, Opalescence, Visual and sub-visible particles
- Microbiological methods: Sterility, Bioburden, Endotoxins, Pyrogens