Biologics

ARL Bio Pharma tests a wide range of therapeutic modalities, such as small molecules, monoclonal antibodies, proteins, peptides, as well as gene and cell therapies. Our extensive testing services support drug development by providing data that helps optimize formulations and establish therapeutic dosages. We provide customized bioanalytical solutions designed to help drug manufacturers advance their pipelines and ensure the delivery of safe and effective products to patients.

Our biologic characterization services use Liquid Chromatography-Mass Spectrometry (LC-MS)-based methods. These advanced methods are used to assess the structure and purity of intact monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, and other peptide and protein therapeutics. This analytical platform provides essential data for protein identification, mass confirmation, and structural characterization, to support the quality and consistency of drug products.

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Acetylation

This test detects, identifies, and quantifies acetyl group additions that influence protein interactions. 

Aggregates Identification

This test identifies and evaluates the properties of aggregates, including their size, types of interactions, structural features, and formation mechanisms. Additionally, it characterizes and quantifies protein aggregates formed during manufacturing and storage. 

Amino Acid Analysis

This test determines and quantifies the specific amino acid composition of the drug product or substance. 

Biologic Stress Testing

This test detects cellular stress by analyzing protein structural changes. 

C-Terminal Lysine

This test detects the presence of a lysine residue at the protein’s C-terminus.

Charge Variants Identification and Characterization

This test detects and analyzes protein forms that differ in net charge due to sequence variations or modifications. 

Deamidation

This test detects and quantifies the amount of asparagine (Asn) and glutamine (Gln) residues in proteins. 

Glycosylation and Glycoform Profiling

This test identifies, quantifies, and characterizes glycans associated with proteins, including their structural and site-specific mapping, which details the types, locations, and distributions of glycans on the protein.

Host Cell Protein Identification

This test uses ELISA and LC-MS/MS methods to detect residual host cell proteins that remain after purification. 

Isomer Differentiation

This test identifies structural isomers, their specific locations on proteins, and quantifies isomerization along with its functions.

N-/C-Terminal Truncation

This test analyzes intact proteins to confirm the presence or absence of truncations, exact cleavage sites, relative abundance, and other associated modifications at N- and C-termini.

Oxidation

This test detects and quantifies the amount of protein oxidation. 

Peptide Mapping

This test provides a detailed characterization of proteins by identifying and quantifying post-translational modifications (PTMs), confirming amino acid sequences, and analyzing structural integrity using MS/MS data. 

Phosphorylation

This test measures the addition of phosphate groups and provides data on protein activity and signaling functions.

Post Translational Modification (PTM) Profiling

This test identifies and determines the location of protein or peptide amino acid modifications, as well as the modified protein/peptide molecules carrying these modifications. 

Protein Identification

This test characterizes proteins and peptides by analyzing their intact mass.  

Sequence Coverage

This test determines the percentage of a protein's amino acid sequence identified through peptide fragment analysis. This represents the distribution of detected peptides across the protein, providing insight into sequence coverage. 

Subunit Analysis with Sequence Coverage

This test breaks down proteins into subunits to characterize their structure, integrity, and post-translational modifications (PTMs). 

Subunit Analysis of Monoclonal Antibodies

This test characterizes protein structure modifications by breaking down the antibody into smaller subunits to determine structural quality attributes such as deamidation, oxidation, glycation, aggregation, and glycosylation patterns. 

Stability Testing

This test measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of manufacturing. 

Thermal Stability Testing

This test detects and characterizes how a protein maintains its structure and function at different temperatures.