Emery Pharma’s Biologics Characterization Services provide comprehensive analytical support for proteins, antibodies, and complex biologics at every stage of drug development. Utilizing advanced HRMS, LCMS-MS, UPLC, and HPLC platforms, our scientists accurately define molecular identity, assess structural integrity, and ensure compliance with ICH and USP regulatory standards.
Our integrated capabilities include peptide mapping, post-translational modification (PTM) analysis, intact mass analysis, comparability studies, host-cell protein (HCP) analysis, and drug-antibody ratio (DAR) analysis. Together, these services deliver the structural, functional, and impurity data necessary to support IND, BLA, and biosimilar submissions while ensuring manufacturing consistency and product quality.
-
Target Industry
Pharmaceuticals, Biotechnology
-
Applicable Standards
ICH Q6B (biotech product specifications/characterization), ICH Q5E (comparability of biotech/biological products), USP <1132> (Residual HCP Measurement)
-
Target Product / Molecule Type
Biologics, Proteins, Biosimilars
-
Instrumentation & Analytical Platforms
HRMS, LCMS-MS, UPLC, HPLC, LC-HRMS
-
Turnaround Time
2-3 weeks
-
Sample Requirements
10-50 µg minimum
Biologics Characterization Services for Proteins, Antibodies and Complex Biologics
We provide Peptide Mapping, Biologic Identity Confirmation/Intact Mass Analysis, Biologics Quality Control, Protein Modification Profiling/PTM analysis, Functional Characterization/Bioassays, Biosimilar Characterization/Comparability, and Antibody-Drug Conjugate (ADC) Characterization.
Peptide Mapping
Description
Emery Pharma performs peptide mapping to confirm primary amino acid sequences, verify protein identity, and detect sequence variants in biologic products. This analysis supports product development, characterization, and regulatory submission requirements.
Methodology
Using liquid chromatography, high-resolution mass spectrometry (LC-HRMS) and LCMS-MS platforms, peptide fragments are generated and analyzed with precision in accordance with ICH Q6B guidelines. This enables accurate sequence coverage and reliable protein identification across biologics and biosimilars.
Deliverables
• Comprehensive peptide maps with sequence confirmation
• High-resolution chromatograms and mass spectra
• Detailed analytical report
Intact Mass Analysis
Description
Intact mass analysis determines the molecular weight of proteins and biologics to confirm product identity, detect variants, and assess quality throughout development and manufacturing.
Methodology
Using LC-HRMS and LCMS-MS, intact protein samples are analyzed under denaturing or native conditions. Results provide rapid, accurate mass confirmation and heterogeneity detection.
Deliverables
• Intact mass spectra and calculated molecular weights
• Variant and heterogeneity assessment
• Detailed report supporting regulatory identity testing
Host-Cell Protein (HCP) Analysis
Description
Our HCP analysis detects and quantifies residual host-cell proteins and other process-related impurities to ensure product purity, safety, and regulatory compliance.
Methodology
Using LC-HRMS and LCMS-MS in alignment with USP <1132> and ICH Q6B standards, Emery Pharma provides sensitive, quantitative measurement of HCPs in biologic drug substances and products.
Deliverables
• Quantitative impurity profiles
• HCP identification and abundance reports
• Regulatory-compliant documentation for GMP batch release
Post-Translational Modification (PTM) Analysis
Description
Our PTM analysis services identify and characterize protein modifications such as glycosylation, oxidation, or deamidation, critical attributes influencing protein stability and activity.
Methodology
Emery Pharma employs LC-HRMS and LCMS-MS to profile PTMs following ICH Q6B characterization standards. Advanced data analysis provides insight into modification sites, abundance, and their potential impact on biologic performance and stability.
Deliverables
• Quantitative PTM profiles and site mapping
• Comparative reports across lots or formulations
• Regulatory-ready documentation for product characterization
Comparability Studies
Description
Emery Pharma conducts comparability studies to evaluate the structural and functional consistency of biologics following manufacturing changes, scale-up, or site transfers, key quality attributes for biosimilar development and regulatory compliance.
Methodology
Comprehensive characterization is performed using LC-HRMS and LCMS-MS per ICH Q5E guidelines, comparing pre- and post-change material attributes to confirm equivalence in structure, purity, and potency.
Deliverables
• Comparative analytical data sets (pre-/post-change)
• Statistical and interpretive comparability assessment
• Documentation suitable for inclusion in CMC submissions
Drug-Antibody Ratio (DAR) Analysis
Description
Drug-antibody ratio (DAR) analysis quantifies the average number of payload molecules conjugated to each antibody in antibody-drug conjugates (ADCs), ensuring consistent potency and safety.
Methodology
Emery Pharma uses LCMS-MS, LC-HRMS, UPLC, and HPLC platforms to measure conjugation levels and distribution across ADC samples. This analysis supports CMC submissions, process optimization, and stability studies.
Deliverables
• DAR quantification data and spectra
• Payload distribution profiles
• Comprehensive report suitable for regulatory filing
Request Your Biologics Characterization Services
Our Scientists
Dr. Prajita Pandey, Ph.D. is an accomplished analytical chemist and Associate Director of the Chemistry Department at Emery Pharma, where she leads biologics characterization and protein analysis initiatives. She specializes in developing and validating analytical methods for complex biomolecules such as monoclonal antibodies, ADCs, peptides, and proteins using advanced LC-MS and LC-HRMS technologies.
News & Blog Articles
Why Choose Emery Pharma for Biologics Characterization
-
GLP/GMP Compliance
Emery Pharma has a robust quality system and can validate, analyze, and characterize biologics using our suite of advanced qualified instruments. -
Regulatory Expertise
Our scientists have extensive experience with ICH Q6B, ICH Q5E, and USP <1132>, aligning analytical strategies with global expectations for biologic identity, purity, and comparability. -
Breadth of Instrumentation and Methodologies
Emery Pharma’s suite of LCMS-MS, HPLC, UPLC, and LC-HRMS platforms enables comprehensive structural and functional analyses for proteins, biosimilars, and ADCs from discovery through commercialization. -
Rapid Turnaround Times
Streamlined workflows and expert data processing allow timely delivery of results, supporting accelerated development timelines and regulatory milestones. -
Rapid Turnaround Times: We understand the urgency of regulatory deadlines and deliver high-quality nitrosamine study reports within accelerated timelines.
-
Cross-Industry Experience
Serving both pharmaceutical and biotechnology clients, Emery Pharma tailors characterization programs for novel biologics, biosimilars, and complex ADCs to meet diverse regulatory and manufacturing needs.
projects delivered on time
average lead time for study initiation
response time to new requests
Common Peptide Mapping Questions
What is peptide mapping?
Peptide mapping is an analytical technique used to confirm the primary amino acid sequence of a therapeutic protein. It involves digesting the protein into smaller peptides, which are then analyzed using mass spectrometry.
How does peptide mapping differ from peptide sequencing?
What information does peptide mapping provide?
What are the main applications of peptide mapping?
What factors affect depth / coverage of peptide mapping?
How should samples be prepared for peptide mapping?
Frequent Post-translational modification (PTM) analysis questions
What are post-translational modifications, and why do they matter?
PTMs are chemical or structural changes proteins undergo after translation (e.g. glycosylation, phosphorylation, oxidation). They impact protein function, stability, immunogenicity, and therapeutic efficacy.
What kinds of PTMs can Emery Pharma detect and characterize?
How is PTM analyzed?
Can mass spec distinguish between different PTMs at the same amino acid?
What instruments are used in PTM analysis?
Common Questions on Intact Mass Analysis
What is intact mass analysis?
Intact mass analysis measures the molecular weight of the whole protein (or large subunits) without enzymatic digestion, allowing rapid assessment of the protein’s overall mass and major heterogeneity.
How does intact mass analysis complement peptide mapping?
How does intact mass analysis contribute to the characterization of antibody-drug conjugates (ADCs)?
What are the advantages of using intact mass analysis over peptide mapping in certain scenarios?
Frequently Asked Comparability Studies Questions
When is a comparability study necessary?
A comparability study is needed when a manufacturing process change is implemented, such as changing the cell line, production scale, manufacturing location, or purification method. The study determines if the quality of the "post-change" product is highly similar to the "pre-change" product.
What methods are used in a comparability study?
How does Emery Pharma support comparability studies?
What challenges are associated with comparability studies?
Host-Cell Protein (HCP) Analysis Q&A
What are host-cell proteins (HCPs) and why are they a concern?
HCPs are protein impurities derived from the host organism (e.g., CHO cells, E. coli) used to produce the therapeutic protein. Residual HCPs can reduce drug efficacy or trigger an immunogenic response in patients, making their detection and removal critical for drug safety.
What methods are used to detect and quantify HCPs?
What considerations are there for using LC-MS vs ELISA for HCP analysis?
When should HCP analysis be performed during biologic development?
What is the main challenge in HCP analysis and how can it be addressed?
Question on Drug-Antibody Ratio (DAR) Analysis
What is the Drug-Antibody Ratio (DAR)?
DAR refers to the average number of drug molecules conjugated to a single antibody in an antibody-drug conjugate (ADC). This ratio is crucial as it influences the therapeutic efficacy and safety profile of the ADC.