Analysis and Characterization of Peptide, Protein, Oligonucleotide and Macromolecule Therapeutics

Intertek ASG Laboratory, Manchester, UK

Analysis of Proteins and Macromolecules

State-of-the-art capabilities for analysis and characterization of peptides, proteins, oligonucleotides and other macromolecule therapeutics in R&D, CMC Packages and QC.

The Intertek ASG laboratory has invested heavily in developing state of the art capabilities for the characterization of peptides, proteins, oligonucleotides and other macromolecule therapeutics. This combination of advanced technical capability and regulatory competence positions the laboratory well for partnering with small to medium sized biotechnology companies in taking their compounds in to and through the various stages of clinical development. The laboratory also offers credible outsourcing options for organisations of any size engaged in the research, development or manufacture of macromolecule therapeutics.

ASG Capabilities and Services Include:

Extensive capabilities in the characterization of chemically synthesised macromolecules, such as peptides from solid phase synthetic processes

Protein fingerprinting by enzymatic digest and LCMS, including multiple digest strategies where appropriate to gain full sequence coverage

MS/MS sequencing of peptidic fragments including N and C-terminal sequencing
Amino acid analysis

Protein disulfide bridge mapping:
- Efficient MALDI procedures
- Advanced technques including predictive and data analysis approaches for interpreting complex proteins with multiple or adjacent bridges
Characterization of protein post-translational modifications (PTMs) including glycosylation:

Glycan cleavage and chromatographic fingerprinting
Academic collaborations on advanced MS of glycosylated proteins, including glycan sequencing

Method development, validation and GMP QC services for residual process impurities, such as antibiotics
Protein impurity characterization using LC-MS, LC-MS/MS, SDS-PAGE, CE, and IEF methodologies

Protein aggregation state studies by MALLS, SEC-MALLS, dynamic light scattering (DLS) and electron microscopy (TEM and SEM)

Protein characterization packages linked to Common Technical Document section headings and key ICH guidance documents
Biopharmaceutical comparability studies
Biopharmaceutical process and product related impurity analysis
Biopharmaceutical product related impurity isolation

ASG Laboratory Protein Analytical News:

The Intertek ASG Laboratory has recently invested in additional LC-MS/MS and related automation equipment. The Applied Biosystems Q TRAP LC-MS/MS system offers state of the art sensitivity and quantitative performance and is also particularly well suited to the study of protein post translational modifications. These investments, together with existing access and expertise provide a solid foundation for proteomics work related to areas such as food or healthcare.