At BioPharmaSpec, we understand the importance of protein characterization during the development and production of your biologic. Our experienced team specialize in a wide variety of analytical testing methods to help power your molecule to success.
Our comprehensive range of analytical services meet global regulatory requirements for biopharmaceutical characterization. With our commitment to quality, you can be sure that your characterization project will be completed accurately, on time and within budget.
Boasting decades of technical experience, our scientists have perfected the use of sophisticated instruments, cutting-edge technologies and specific analytical strategies to aid in the development of your product, whether you are developing a novel molecule, a biosimilar, a peptide, an antibody, a bi/multi-specific, a drug-conjugate or any other molecule!
Protein Analysis
During biopharmaceutical development, detailed and thorough characterization should be performed according to the ICH Guideline Q6B which advises that up-to-date analytical technologies should be utilized. BioPharmaSpec uses state-of-the-art instrumentation and a pioneering approach to methodology to characterize your biopharmaceutical to the highest technical standard.
Structural & Physicochemical Characterization
Biophysical Characterization
Purity and Impurities
Host Cell Protein (HCP) Analysis & Detection
BioPharmaSpec has developed a service for MS based HCP detection and quantitation as an orthogonal support to HCP-ELISA.
Process Related Impurities
BioPharmaSpec provides methods for the analysis of a significant range of process related impurities. These methods have been developed to allow identification and quantitation to low ppm/ppb limits.
Protein Characterization Methods
| Amino Acid Analysis | Triplicate hydrolysis, duplicate injection |
| N-terminal Sequencing | 15 cycles (of light and heavy chains) |
| C-terminal sequencing | Determined through molecular weight and peptide mapping |
| Peptide Mapping | At least three digestion strategies LC/ES-MS, Q-TOF |
| Glycosylation site occupancy | Assessment of the degree of glycosylation site occupancy |
| Primary sequence confirmation | MS based sequencing and Ile/Leu differentiation using Edman for the full sequence |
| Disulfide Bridge Assessment | Determined through peptide mapping |
| Monosaccharide Composition Analysis | Neutral and amino sugars Sialic acids |
| Oligosaccharide profiling | HILIC analysis of 2-AB labelled oligosaccharides covering the analysis of total N-glycans Linkage (methylation) analysis |
| Intact molecular weight analysis | As received, following reduction, following de-N-glycosylation, following reduction and de-N-glycosylation. On line RP-HPLC-MS |
| icIEF | With and without Carboxypeptidase B treatment |
| CE-SDS | Non reducing and reducing |
| RP-HPLC with UV detection | Performed on the sample as received |
| Ion Exchange Chromatography | Isoforms can be collected and characterized |
| DSC | To assess melting temperature |
| CD | For far-UV (for secondary structure) and near UV (for tertiary structure) |
| FT-IR | Secondary structure |
| IF | Secondary and tertiary structure |
| 1D and 2D NMR | Secondary and tertiary structure |
| SEC-MALS | Aggregation assessment |
| SV-AUC | Orthogonal aggregation assessment |
| Cell based assay(s) | Functional assessment |
| Binding assay(s) | Assessment of binding affinity to receptors, ligands etc |
These characterization techniques can be included in specific study designs tailored to your molecule. Expert data interpretation and technical summaries provided by BioPharmaSpec scientists will enable you to make key development decisions. We support you with:
- New, innovative product characterization
- Structural and physicochemical characterization to ICH Q6B
- Comparability studies
- Biosimilarity studies
- Forced degradation studies
- Stability studies
- Product impurity analysis and quantitation
- Host Cell Protein detection using Mass Spectrometry
Need protein structure characterization services?
Work with BioPharmaSpec scientists to design effective characterization strategies that will allow you to make solid development decisions based on quality analytical data.