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Applications Compendium

Biopharmaceutical Development and QA/QC  


Review your analytical needs for characterization of biopharmaceuticals

Find relevant applications for your analytical needs

Intact Proteins

Robust and reliable separation and measurement

Purified Protein
Mass Spectrometry
Purified Protein
Purified Protein
Due to the complexity of the cellular process controlling the synthesis and translocation of macromolecules, the efficiency at which host cells secrete the target protein into culture medium is largely dependent on individual cell line. Thus, at an early stage of biopharmaceutical development, screening is performed for selecting a cell line that is most suited as the vehicle for the product manufacturing.


Addressing both fast screening and full profiling

Purified Protein

Enzymatically Release Glycan

Label and Purify

Purified Protein

Enzymatically Release Glycan

Label and Purify

The presence of the glycan moiety and its structural profile must be monitored, since it affects not only the effector function, but also ADME and immunogenicity. Acquiring the glycan structure profile at an early stage of biotherapeutic development helps eliminate any molecules expressing high levels of unfavorable glycan species. At later stages of biotherapeutics development, full characterization of glycan profile is required in order to define the reference glycan profile of a product for later QA/QC.


In-depth characterization of primary structure

Purified Protein

Enzymatic Digestion


During process development and before entering clinical trials, the primary structure of a recombinant protein must be confirmed, and all potential post-translational modifications (PTM) must be characterized to assess the associated risk. Peptide mapping is the fundamental technique for this purpose, whereby the recombinant protein is enzymatically digested into peptide fragments that are chromatographically separated to give a fingerprint of the primary structure. When coupled to mass spectrometry, peptide mapping can also give precise identification of various PTMs.

Culture Media

Comprehensive analysis made fast and easy

Cell Culture Supernatant

Protein Precipitation


Differential Analysis
Cell Culture Supernatant

Automated Cell Culture Media Analysis Platform (C2MAP)
The increasing interest in biopharmaceuticals has resulted in significant growth in the cell culture market, as scientists demand optimal media to ensure the viability of their work. Cell culture media must contain a precise balance of components, such as glucose, glutamine, nucleic acid, vitamins, and other biologically important compounds and primary metabolites. Ensuring that cell culture media have the optimal formulation for growth and are free of impurities is vital to the success of biopharmaceutical development.


Accelerating the pre-clinical/clinical phase

Plasma Sample

nSMOL Proteolysis

Signature Peptide Selection

MRM Optimization
One-day work required for method development
Bioanalytical method development is the critical step in the biopharmaceutical pipeline as it bridges the transition to pre-clinical and clinical phases. Ligand-binding assay (LBA) has been the common technique for biologics, however, LC-MS is emerging as an alternative to reduce time and cost needed for method development and to gain increased selectivity and efficiency.


Investigation of protein aggregation and more

Protein Aggregates
Aggregate sizer
Analysis of Polysorbate 80 GC
Elemental Impurities ICP-MS
Leachables GC-MS/MS
Biopharmaceutical products are no different from small molecule pharmaceuticals in that all impurities derived from the raw materials, manufacturing process, formulation and instability need to be fully investigated and controlled (ICH Q3). However, in addition to conventional impurities, such as elemental impurities, there are certain issues that require particular attention due to the labile nature of proteins.

Data Management / Integrity

Total Solution for Regulatory Compliance



Unified Data

Network Platform

Data integrity compliance has become one of the most important components of the pharmaceutical industry’s responsibility to ensure the safety, efficiency and quality of drugs to protect human health. However, regulatory agencies have observed an increasing number of Current Good Manufacturing Practice (CGMP) violations related to data integrity in recent years. Regulatory agencies expect data to be reliable and accurate on the CGMP criteria for all laboratory instruments, including UV-Vis and FT-IR, as well as all other standalone instruments.

Download our Biopharmaceutical Applications Compendium to learn more

Biopharma Application Compendium