Step-by-Step Glycan Analysis of a Biologic Therapeutic

Dr. Rodney Bannwart, a principal scientist at Emery Pharma, discusses the importance of glycan analysis in biopharmaceutical development. Glycosylation, a process where sugars are attached to proteins, can affect the activity, function, and immunogenicity of therapeutic proteins and monoclonal antibodies (mAbs). The glycan profile of these molecules varies depending on cell health and is monitored for consistency. The glycan profile is also crucial for assessing biosimilarity. LC-MS analysis is commonly used to obtain glycan information. The protocol involves treating protein or mAb samples with an enzyme to release glycans, isolating the glycans, and then analyzing them using LC-MS. Fluorescence detection is recommended for its sensitivity. The obtained glycan information helps characterize the glycan profile and can be used for comparability studies. Dr. Bannwart presents a case study on a mAb, identifying over 25 glycans. He emphasizes that LC-MS analysis is the most accurate and sensitive method for characterizing glycan profiles, which are important throughout the product development cycle. While a modern mass spectrometer is typically used, a fluorescence detector can be employed to reduce costs without compromising sensitivity. In conclusion, understanding and monitoring the glycan profile of proteins and mAbs is crucial for ensuring their efficacy and safety in biopharmaceutical development. The presented LC-MS analysis method provides valuable insights into glycan profiles and is applicable from early development to commercialization.


About Emery Pharma:
Emery Pharma is a full-service contract research laboratory, supporting the end-to-end development of small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.
Emery Pharma is a full-service contract research laboratory, supporting the end-to-end development of small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.

Emery Pharma's premium services include analytical, bioanalytical solutions, microbiology & cell biology services, drug and impurity characterization, and general R&D and cGMP/GLP support.
At Emery Pharma, our focus is to find innovative solutions for our Clients’ toughest challenges and tailoring those solutions to fit each Client’s unique needs. Our experienced scientific team will manage the process: from drug discovery, proof-of-concept, data management, data analysis, to gathering insights. The team excels at solving scientific challenges, and addressing any issues early in the process, so Clients don’t experience unnecessary setbacks.
Emery Pharma’s experienced chemists and biologists deploy state-of-the-art technology. Instrumentation ranges from high-resolution mass spec (Orbitrap), Triple quad LC-MS/MS, GC-MS, Preparative HPLC, and 400 MHz multinuclear NMR.

Keywords:
Dr. Rodney Bannwart
principal scientist
Emery Pharma
glycan analysis
biopharmaceutical development
glycosylation
sugars
proteins
activity
function
immunogenicity
therapeutic proteins
monoclonal antibodies (mAbs)
glycan profile
cell health
consistency
biosimilarity
LC-MS analysis
protein
mAb
enzyme
glycans
fluorescence detection
accuracy
product development cycle
mass spectrometer
fluorescence detector
early development
commercialization