Biological Products Analysis Service

Drugs with biological origins are still the mainstream treatments for many diseases. These drugs include antibodies, recombinant proteins, vaccines, etc. With technological progression and expending demands, hundreds and thousands of new biopharmaceutical drugs have been developed each year. However, successful development of these drugs relies on ensuring the quality, potency, and safety of your biopharmaceutical product, as impurity and defection of these biopharmaceutical products may compromise the efficacy and place potential risks when applied in clinical stage. Therefore, evaluation of biopharmaceuticals is critical and necessary before clinical trials. To help solve the challenges in the developmental process of biopharmaceutical products, MtoZ Biolabs has established a comprehensive analytical platform for biopharmaceutical analysis, and is able to cover most biopharmaceutical related requirements. We strictly follow the International Conference on Harmonisation (ICH) guidelines of technical requirements for registration of pharmaceuticals for human use.

Technical Platforms

Capillary Isoelectric Focusing

2D-DIGE

Size Exclusion Chromatography (SEC)

High Performance Liquid Chromatography (HPLC)

Reversed-Phase Chromatography (RP)

MALDI-TOF-MS/MS

ESI-TOF-MS/MS

Native MS

Hydrogen-Deuterium Exchange (HDX) MS

Identification of Biopharmaceuticals

Molecular Weight Analysis

For accurate molecular weight confirmation, MtoZ Biolabs combines MALDI-TOF MS and ESI-MS to measure proteins, peptides, antibodies, vaccines, and related subunits, dimers, trimers, or complexes.

N/C Terminal Sequencing

MtoZ Biolabs provides N/C Terminal Sequencing by combining Edman degradation and MALDI-TOF MS to analyze terminal sequences, N-terminal blockage, and terminal modifications in proteins, peptides, and biopharmaceuticals.

Peptide Mapping

MtoZ Biolabs provides Peptide Mapping Service using LC-MS/MS or UV-LC-MS/MS to analyze enzymatic peptides, confirm sequence integrity, assess coverage, and support biopharmaceutical identity and quality evaluation.

Amino Acids Composition Analysis

With derivatization and HPLC, MtoZ Biolabs' Amino Acid Composition Analysis quantifies amino acid content in proteins, peptides, and biopharmaceuticals, supporting composition confirmation and sequence-related characterization.

Variation Analysis of Biopharmaceuticals

Glycan Profiling

MtoZ Biolabs delivers Glycan Profiling Service using high-resolution MS to characterize glycosylation in peptides, proteins, antibodies, and biopharmaceuticals, supporting evaluation of glycan structures, heterogeneity, and critical quality attributes.

Glycosylation Site Analysis

MtoZ Biolabs applies MALDI-TOF MS and nano LC-ESI-MS/MS in Glycosylation Site Analysis to identify N- and O-glycosylation sites in antibodies, recombinant proteins, serum/plasma, cell media, and cell lines.

Disulfide Bond Analysis

MtoZ Biolabs supports structural confirmation through Disulfide Bond Analysis, using high-resolution MS to characterize disulfide linkages and free cysteines in antibodies, recombinant proteins, and biopharmaceuticals.

Purity Analysis of Biopharmaceuticals

Purity Analysis（SDS-PAGE）

MtoZ Biolabs offers SDS-PAGE Purity Analysis to separate proteins, peptides, and biopharmaceutical samples, evaluate purity, detect impurity or degradation bands, and estimate relative molecular weight.

Purity Analysis (SEC & RPLC)

MtoZ Biolabs enables SEC and RPLC Purity Analysis to assess aggregates, oligomers, fragments, impurities, and main peak proportions in proteins, peptides, antibodies, and other biopharmaceutical samples.

Host Cell Protein (HCP) Analysis

MtoZ Biolabs combines 2D DIGE and Western blot in Host Cell Protein Analysis to detect residual HCPs in antibodies, vaccines, recombinant proteins, and products from diverse expression systems.

Antibody-Drug Conjugate (ADC) Analysis

MtoZ Biolabs provides ADC Analysis using LC-MS/MS and high-resolution MS to characterize antibodies, linkers, and payloads, supporting DAR determination, conjugation site identification, integrity assessment, stability testing, and impurity profiling.

*Apart from the above services, we can also provide customized service for other types of biologics and biopharmaceuticals. You are welcome to contact us for specific requirement related to these biopharmaceuticals.