Biopharmaceutical Services and Applications

Macromolecule pharmaceuticals can present significant analytical challenges to the development path of a new product. Intertek Pharmaceutical Services is highly experienced in providing comprehensive biophysical characterization services for biopharmaceuticals and so however complex your product, Intertek can help your product development process.

Intertek has extensive expertise and experience in the physicochemical characterisation of protein therapeutics and other macromolecule medicines such as synthetic peptides, antibodies therapeutics, functionalized polymers and oligonucleotides. Services include advanced R&D and regulatory characterisation studies, method development and validation and QC services across a diverse range of advanced and standard analytical technique areas. Laboratories are GLP certified / cGMP compliant allowing Intertek data to be used in regulatory submissions, R&D support and in batch release analysis.

Biopharmaceutical Services include:

• Structural Characterisation and Confirmation

• Method Development and Validation

• Higher Order Structural Characterisation

• Aggregation State Characterisation

• Isolation and Characterisation of Product Related Impurities

• Process Impurity Method Development, Validation and QC

• Comparability Studies

• Stability Studies

• Specialist Services for Antibody Therapeutics

• Immunochemistry services
  

Biopharmaceutical Applications:

• Peptides

• Recombinant proteins

• Protein conjugates

• Antibody therapeutics

• Oligionucleotides and DNA medicines

• Vaccines

• Functionalised oligomers and polymers