For modern biopharmaceutical research, it is necessary to combine different analytical methods with each other in order to obtain a more complete assessment of the protein structure and function.
Characterization of Biopharmaceuticals and Biosimilars
Working with biologic drugs represents a huge analytical effort to deeply understand the whole molecule characteristics. Different methods and technologies are needed to get the analytical fingerprint. An extensive analytical characterization based on an ortogonal approach is a key element for the project success.
Benefit from reliable analytical capabilities
Reliable, robust analytical methods are imperative for successful drug development and commercialization. Method development, qualification, and validation play a pivotal role in understanding the critical quality attributes of the molecule, which help to define the robust control strategy required to manufacture and commercialize biologic molecules.
The application of mass spectrometry in protein research has revolutionized the analysis of the large and complex molecules. Protagen Protein Services (PPS) operates various state-of-the-art devices to carry out mass spectrometry analyses by LC-ESI-MS, MALDI-MS and MALDI-ISD.
At PPS we apply modern mass spectrometry techniques for the analysis of Biopharmaceuticals for following approaches:
- Peptide Mapping
- Sequence verification
- Protein characterization
- Disulfide Linkage
- HCP analysis
- HCP quantification
- N-linked glycosylation
- O-linked glycosylation
- Intact Mass
- Middle-Down analysis
- De-Novo sequencing
- Glycosylation site
- H-D-Exchange Analysis (HDX MS)
- Absolute Quantification of HCP (PRM, MRM)
- Protein identification
- Release testing
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity