Protein Analysis
SGNCO has cutting-edge facilities to
perform a broad analysis portfolio of proteins, peptides and antibodies. Our
team of experts checks out for the purity and homogeneity of the protein and
finds out possible impurities and aggregation complexes. Various analytical
test methods include classical SDS-PAGE and blotting techniques,
chromatographic methods, mass spectrometry detection techniques etc. We use
a wide range of protein analysis techniques including:
Protein Purity
- IE-HPLC
- RP-HPLC (UV, ELSD, fluorescence)
- SEC-HPLC
- Variants analysis (LC/MS/MS)
- IEF ? SDS-PAGE (reduced, non-reduced)
- Degradation products (LC/MS/MS)
- N-terminal sequencing
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Protein Identity
- Western Blotting
- Disulfide bridges characterization
- IEF
- Amino Acid Analysis
- Peptide mapping and intact protein mass analysis
- PEGylation status
- Antibody typing and subclasses analysis
- Exact mass determination
- Phosphorylation status
- Methionine oxidation status
- Sequence confirmation (LC/MS/MS)
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Protein/ Antibody Aggregation
Analysis
Molecular Mass Analysis
- SDS-PAGE
- HPLC/MALLS
- LC/MS/MS (QTof)
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Glycosylation Analysis
- Glycan chains integrity
- Glycosylation sites (LC/MS/MS)
- Carbohydrate composition analysis (HPAEC-PAD)
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Biological Activity
- Confirmation of Immunogenicity
- Enzymatic assays
- ELISA
- Challenge test
- Protein concentration
- Bioassays
- Production of polyclonal antibodies
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Sterility
- pH
- Appearance
- Pyrogenicty testing
- Endotoxins testing
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QC of Biopharmaceuticals
SGNCO offers GMP compliant quality
control for biopharmaceuticals. The quality control includes method
development & validation for various stages like raw material testing,
batch release testing, product analysis and microbiological testing. Routine
quality control operation techniques include LS/MS/MS, SDS-PAGE, capillary
electrophoresis and RT-PCR.
The company has state-of-the-art laboratories and excellent validation
methods that assist in ensuring reliable results. SGNCO has dedicated cell
culture laboratories and nucleic acid amplification laboratory that are
designed to avoid cross-contamination during testing. SGNCO life sciences QA
services include:
- Laboratory equipment validation
- On-site GMP/GLP training
- Regulatory affairs support
- 4DIN application
- On-site GMP audits
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Regulatory Affairs
SNGCO has a team of experts for
comprehending all regulatory aspects of marketing authorization for medicine
and veterinary products. The services are available for the entire drug
development process right from pre-clinical formulations till marketing. Our
experts find out the most appropriate route to market the medicinal products
with European Regulatory Agencies. SGNCO's regulatory affairs services
include:
- Clinical trials regulatory support
- Marketing and authorization applications
- Labeling
- Medical writing
- Medical devices
- Cosmetics, food supplements and nutriment biocides
- Representation of the companies
- On-site consulting with qualified and multilingual staff
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