At Alliance Pharma our mass spectrometry based bioanalytical team offers method development, assay validation and specimen analysis using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS). Here we’ll share more details about these services and the technology we use.
Small Molecule Bioanalysis
Our bioanalytical team at Alliance Pharma has extensive experience developing and validating robust LC-MS/MS methods for a wide variety of small molecule compounds in diverse biological matrices. From the most hydrophobic drug molecules to hydrophilic endogenous biomarkers, we’ve helped many clients resolve their most difficult bioanalytical challenges in both preclinical and clinical programs.
Our labs have state-of-the-art equipment including a variety of triple quad mass spectrometry systems. We also provide metabolite identification support using our OrbitrapTM (XL) and Q-ExactiveTM high resolution instruments. And don’t forget about our most recent addition, an Agilent 8900 ICP-MS system that allows us to support metals analysis in biological and environmental matrices.
Large Molecule Bioanalysis
Our bioanalytical team at Alliance also has extensive experience developing and validating robust LC-MS/MS methods for a wide variety of large molecules, including large peptides, proteins, antibody drug conjugates, and oligonucleotides that may be new therapeutics or endogenous biomarkers. We have the tools and expertise to analyze your large molecules intact or digest them into unique signature peptides for highly specific and sensitive quantitative analysis. We’ll often use our newly acquired Agilent 6545XT AdvancedBio LC/Q-TOF systems to support intact protein quantitative analysis.
Our expertise and service support in both small and large molecule quantitative bioanalysis includes:
- Regulated (GCP & GLP) and R&D support
- Method development, transfer and optimization
- Method validation
- Sample analysis
- All phases (Phase I, II, II, IV) of regulated clinical studies
- Regulated preclinical TK/PK/PD/DM studies
- High-throughput sample analysis for discovery PK/PD studies
- Tissue sample analysis
- In vitro screening studies
As part of a comprehensive suite of bioanalytical services, Alliance Pharma also provides protein characterization for structural elucidation and peptide sequencing of large molecules. Whether you’re developing a novel therapeutic protein or a biosimilar, we have a broad range of tools to support your development program and meet your regulatory needs. Our protein characterization services are performed according to ICH Q6B guidance and include the following:
- Protein and antibody characterization
- Peptide mapping
- Disulfide bridge and free sulfhydryl analysis
- N-Glycan profiling
- Monosaccharide composition analysis
- Sialic acid analysis
- Assessment of post-translational modifications (PTMs)
- Intact mass and subunit analysis
- Chromatographic profiles
- Proteomics and glycomics research support
- De novo sequencing
- Native MS of antibody drug conjugates (ADCs) and protein complexes
- Protein identification
We invite you to contact us at 610.296.3152 or email@example.com to learn more about our technology platforms for these services as well as to discuss how we can help you meet your needs and goals when it comes to bioanalysis.