BioPharmaSpec provides a comprehensive range of protein characterization services to meet global regulatory requirements for biopharmaceutical characterization.

The harmonised ICH guideline Q6b suggests that characterization of a biopharmaceutical should include:

Structural characterization

Biophysical characterization

Biological activity

Purity and impurities

During biopharmaceutical development, detailed and thorough characterization should be performed. If significant process changes are made, the guidelines state that characterization should also be performed following these changes, in order to prove that there have been no major changes to the structure or function of your product.

It is important to make use of the most up-to-date protein characterization methods. The guidelines advise that New analytical technology and modifications to existing technology are continually being developed and should be utilized when appropriate.

BioPharmaSpec uses state-of-the-art instrumentation and a pioneering approach to methodology to characterize your biopharmaceutical to the highest technical standard.

Protein Characterization Services at BioPharmaSpec

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

 

Functional Testing by our strategic partner, Custom Biologics

Custom Biologics is BioPharmaSpec’s strategic partner in providing functional testing such as cell based assays and receptor binding to our clients. Based in Toronto, Canada, Custom Biologics provide a comprehensive range of functional characterization and comparability methods including:

  • Cell based assays
    • Anti-/ proliferation
    • Migration
    • Apoptosis
    • Competitive binding/ inhibition
    • Anti-viral neutralization
  • CDC, ADCC/ alt-ADCC
  • Enzymatic assays/ specific activity
  • Receptor binding assays (e.g. FcR, C1q)
  • Solid phase ligand binding assays

Please contact us to find out how BioPharmaSpec and Custom Biologics can use their joint expertise to accelerate the development of your Biopharmaceutical.

Using protein characterization to support your product development

The above protein characterization methods can be included in specific studies in order to support key development decisions. These characterization techniques and the expert data interpretation and technical summaries you will receive from BioPharmaSpec scientists, will help you choose the best cell clone, provide batch-to-batch comparisons or make innovator to biosimilar comparisons. We support activities such as:

With BioPharmaSpec’s support, solid development decisions can be made based on quality analytical data and experience. Contact us to find out more.