Therapeutics Characterization
High-Resolution Characterization of Therapeutic Proteins
Poochon developed a robust approach using a range of state-of- the-art orthogonal methodologies to elucidate the primary amino acid sequence, post-translational modifications, and associated micro-heterogeneity and glycosylation of therapeutic products.
+ P601: Evaluation of Identity and Purity
Evaluation of Purified or Partially Purified Protein Samples Including Therapeutics Products at the Early Stage of Development
Price: $600 per sample
Turnaround Time: 5 to 10 business days
Service Description
• Identification by enzymatic digestion followed by LC-MS/MS analysis
• All detectable proteins (even at ng level) including any host proteins are identified and their relative abundance determined
• Purity is estimated based on the relative abundance of identified proteins
• Workflow: Sample preparation, enzymatic digestion, LC-MS/MS analysis, data analysis, and results report
Deliverables
• Protein Analysis Report
• List of identified proteins (target and host proteins)
• List of identified proteins with matched peptides sequences
• Purity
• Raw data files, upon request
Suitable Sample Type
• Purified protein samples, in solution or dried (> 5 µg/sample)
+ P602: Full Amino Acid Sequence Confirmation
Confirmation of Full Amino Acid Sequence (>95% Sequence Coverage) of Any Purified Protein Sample With a Known Target Protein Amino Acid Sequence
Price: $1,200 per sample (for de novo sequencing, please contact us for a quote)
Turnaround Time: 10 to 15 business days
Service Description
• Confirmation of full amino acid sequence (> 95% sequence coverage) of purified protein samples (purity > 80%)
• Additional charge applies for mAbs, as both heavy chain and light chain sequences are confirmed
• All detectable proteins (even at ng level) including any host proteins are identified and their relative abundance determined
• Purity is estimated based on the relative abundance of identified proteins
• Workflow: Sample preparation, enzymatic digestion, LC-MS/MS analysis, data analysis, and results report
Deliverables
• Protein Analysis Report
• List of peptides identified for target protein and peptide mapping
• List of identified host proteins, if any
• List of identified host proteins with matched peptides sequences
• Purity
• Raw data files, upon request
Suitable Sample Type
• Purified protein samples, in solution or dried (> 20 µg/sample; purity > 80% )
• Confirmation of full amino acid sequence (> 95% sequence coverage) of purified protein samples (purity > 80%)
• Additional charge applies for mAbs, as both heavy chain and light chain sequences are confirmed
• All detectable proteins (even at ng level) including any host proteins are identified and their relative abundance determined
• Purity is estimated based on the relative abundance of identified proteins
• Workflow: Sample preparation, enzymatic digestion, LC-MS/MS analysis, data analysis, and results report
• Protein Analysis Report
• List of peptides identified for target protein and peptide mapping
• List of identified host proteins, if any
• List of identified host proteins with matched peptides sequences
• Purity
• Raw data files, upon request
• Purified protein samples, in solution or dried (> 20 µg/sample; purity > 80% )
+ P603: Identification of N-linked Glycosylation Sites
Identification of N-Linked Glycosylation Sites From Purified Protein Samples
Price: $1,800 per sample (for O-linked glycosylation, please contact us for a quote)
Turnaround Time: 10 to 15 business days
Service Description
• Identification of N-linked glycosylation sites and confirmation of full amino acid sequence (> 95% sequence coverage) of purified protein samples (e.g., mAb (purity > 95%) using deglycosylation treatment and LC-MS/MS
• Quantification of glycosylation is determined using label-free quantitation method
• All detectable proteins (even at ng level) including any host proteins are identified and their relative abundance determined
• Purity is estimated based on the relative abundance of identified proteins
• Workflow: Sample preparation, deglycosylation treatment, enzymatic digestion, LC-MS/MS analysis, data analysis, and results report
Deliverables
• Protein Analysis Report
• N-linked glycosylation sites
• List of Peptides identified for target protein and peptide mapping
• List of identified host proteins, if any
• List of identified host proteins with matched peptides sequences
• Purity
• Raw data files, upon request
Suitable Sample Type
• Purified protein samples, in solution or dried (> 20 µg/sample; purity > 99%)
• If the purity is less than 90%, please contact us for a quote
+ P604: Profile of N-linked Glycans for Monoclonal Antibodies
Characterization of the Profile of N-Linked Glycans Released From Purified mAb Samples Using Rapifluor-Ms™ N-Glycan Kit and LC-MS/MS
Price: $5,000 per sample
Turnaround Time: 20 to 35 business days
Service Description
• Profiling of N-linked glycans released from pure mAbs (note: If multiple N-linked glycosylation sites are identified, the N-linked glycans profiling analysis will not be performed)
• Relative abundance of glycans is determined based on label-free quantitation method (Ion intensity/peak area)
• Workflow: Sample preparation, deglycosylation treatment, enzymatic digestion, N-linked glycans labeling, LC-MS/MS analysis, data analysis, and results report
Deliverables
• Protein Analysis Report
• N-linked glycans profile
• N-linked glycosylation sites
• List of peptides identified for target protein and peptide mapping
• List of identified host proteins, if any
• List of identified host proteins with matched peptides sequences
• Purity
• Raw data files, upon request
Suitable Sample Type
• Purified protein samples, in solution or dried (> 50 µg/sample; purity > 99% )
submission Guidelines
