Liquid chromatography-mass spectrometry (LC-MS) is a powerful analytical technique that combines liquid chromatography with mass spectrometry. LC-MS can characterize biologics and biosimilars by providing information on molecular weight, structure, and quantity. It has advantages like accuracy, specificity, selectivity, and speed. LC-MS is used in areas like drug discovery, clinical analysis, proteomics, and pharmaceutical applications. Advances in mass spectrometry techniques allow for characterization of protein primary and higher order structures important for biologics development.

1. CHARACTERIZATION OF
BIOGENERICS AND BIOSIMILARS
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2. • CHARACTERIZATION OF BIOGENERICS
AND BIOSIMILARS:
• Structural characteristics of biologics, characterization of
biosimiliars ( LC- MS/MS and affinity capture techniques ),
Problems in characterization of biologics ( peptides, Non - glycosylated
proteins, Glycosylated proteins, Monoclonal antibodies )

3. Biologic medicines contain substances that have been created by using living cells
or organisms.
Examples of biologic medicines include gene therapies, transplant tissue,
recombinant proteins, stem cell therapies, and monoclonal antibodies

4. Liquid chromatography and the mass
spectrometry
(LC-MS)
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5. It is the combination of liquid chromatography and the mass spectrometry.
• Liquid chromatography-mass spectrometry (LC-MS) is an analytical chemistry
technique that combines the physical separation capabilities of liquid
chromatography with the mass analysis capabilities of mass spectrometry.
• The combination of these two powerful techniques gives the chemical analyst
the ability to analyze virtually any molecular species; including, thermally
labile, non-volatile, and high molecular weight species.
• It has been said that over 80% of known organic species are amenable to
separation with liquid chromatography.

6. Mass spectrometry is capable of providing structure, molecular weight,
empirical formula, and quantitative information about a specific analytes so,
LCMS in recent years, liquid chromatography/mass spectrometry (LC/MS) has
become one of the most powerful analytical techniques for qualitative and
quantitative analysis .
Structural mass spectrometry in biologics
discovery:
Advances and future trends

7. Advantages of LC-MS
The LCMS provides accuracy, specificity, selectivity & rapid less time
consuming.
 Provides compound identity.
 Provides sensitive response to most analytes.
 Provides compound class information.
 Provides compound structure.
 Provides sequence information.
 Provides molecular weight information.
 Provides the five 5 Important Criteria
Speed, Selectivity, Specificity, Sensitivity, Low Cost

8. LC-MS USED IN FOLLOWING AREAS
• Drug Discovery
• Clinical Analysis.
• Proteomics
• Forensic Chemistry
• Drug Metabolism study
• Environmental chemistry
• Diagnostic studies.
• Molecular Weight Determination
• Determination of Molecular Weight of Green Florescent Protein
• Structural Determination
• Pharmaceutical Applications
• Identification of Bile Acid Metabolites
• Clinical Applications
• Biochemical Genetics
• Therapeutic Drug Monitoring

9. Mass spectrometry (MS) is one of the key techniques in protein
characterization. The workflow for MS-based structural characterization of
biologics in biopharmaceutical drug discovery includes characterization of
primary and higher order structures.
Advances in MS techniques in protein characterization are illustrated,
including electron transfer dissociation MS (ETDMS) for primary structure
analysis and hydrogen/deuterium exchange MS (HDX-MS) for probing protein
higher order structures and mapping epitopes.
Future trends in applications of MS to evaluate and optimize candidate
molecules in biologics stability studies also..

10. Parameters Biosimilar Generics
Definition
API (Active
Pharmaceutical
Ingredient)
Quality, Safety and
Efficacy
Highly similar Vs
Pharmaceutical
Equivalent
No Clinically
Significant difference
Vs
Bioequivalent and
Therapeutic
equivalent