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last update : 2017-08-03
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26 Sep 2017 - 27 Sep 2017
10th Workshop on Monoclonal Antibodies 2017
Berlin, Germany

08 Jun 2017 - 08 Oct 2017
Our webinar is online: Characterisation of human pluripotent stem cells (ESCs and IPSC) and by-products
Webinar given on June 8th

Peptides

Therapeutic peptides are at the crossroads of small molecules and proteins, requiring a specific analytical package depending whether they are of recombinant or synthetic origin.

In both cases, Quality Assistance provides you with all the analytical technologies needed to support your drug development process including peptide characterization, development and validation of analytical methods to be implemented further in your stability studies, batch testing and bioanalysis to support your non-clinical and clinical studies.

 

 

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Our capabilities in this area are summarized in the following table:

Batch release and stability studies
General quality Appearance
pH / Osmolarity
Isoelectric point
Particulate matter
Particule size (formulation)
Water content / residual moisture
Properties after reconstitution
Solubility
Identity Intact peptide
Molecular weight
Peptide mapping and / or sequencing
Immunological identification
Quantity Assay
Determination of extinction coefficient
Purity and integrity Purity profile
High order structure
Mass distribution profile
Chemical modifications
Degradation patterns
Aggregation and particle size distribution
Disulfide bridges
Free thiols
Enantiomeric purity
Counter-ion content
Potency Immunoassays
Cell-based assays
Process-related impurities Microbiology
Endotoxins
Elemental impurities
Residual solvents (synthetic peptides)
Residual proteins (recombinant peptides)
Residual DNA (recombinant peptides)
Packaging Leachables
Container Closure System Integrity
Cytotoxicity / Biological reactivity
Bioanalysis
PK/TK studies Drug and metabolites
Immunogenicity Anti-drug antibodies
Screening and confirmatory assays
Neutralising assays
GLP formulation studies Buffers
Vehicles
Biomarkers Small molecules
Peptides
Proteins

 

Resources
News
Brochure

Fast and accurate absolute-quantification of proteins and antibodies using Isotope Dilution-Triple Quadrupole ICP-MS

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Brochure  
 

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