Bioanalysis at Emery Pharma: Your Questions Answered
In the fast-paced world of drug development, bioanalysis plays a crucial role in determining a drug’s pharmacokinetics (PK) and pharmacodynamics (PD). At Emery Pharma, we specialize in providing high-quality bioanalytical services to support pharmaceutical and biotechnology companies at every stage of development. Below, we answer some of the most frequently asked questions about bioanalysis—and how Emery Pharma’s expertise can accelerate your research.
What is Bioanalysis, and Why is it Important in Drug Development?
Bioanalysis is a specialized branch of analytical chemistry focused on quantifying and characterizing drugs, metabolites, and biomarkers in biological matrices such as plasma, serum, urine, and tissue. It is essential to drug development because it helps:
- Determine how the body processes a drug (pharmacokinetics)
- Assess how the drug interacts with the body (pharmacodynamics)
- Ensure proper dosing, efficacy, and safety
- Support regulatory submissions with validated, traceable data
Without accurate and validated bioanalysis, drug candidates may face regulatory delays, safety concerns, or even rejection by agencies such as the FDA or EMA.
What Bioanalytical Services Does Emery Pharma Offer?
We provide a comprehensive suite of bioanalytical services, customized to support small molecule, biologics, and peptide development. Our offerings include:
- LC-MS/MS-based quantitation of small molecules, peptides, and biologics
- Bioanalytical method development (de novo and customized)
- Method validation (GLP-compliant validation per ICH M10 guidelines)
- Sample preparation and cleanup for complex matrices
- PK, TK, and ADME studies using LC-MS/MS and HR-MS assays
- Ligand Binding Assays (LBA) for anti-drug antibody (ADA) detection
These services are designed to meet both non-GLP discovery studies and GLP-regulated preclinical and clinical trials.
What Stages of Drug Development Does Emery Pharma Support?
Emery Pharma supports bioanalytical needs across all phases of the drug development pipeline, including:
- Discovery & Preclinical Research – Compound characterization and metabolic stability
- Clinical Trials (Phases I–III) – PK/PD analysis, dose optimization, and safety monitoring
- Regulatory Submissions – Method validation and reporting for FDA, EMA, and PMDA
By identifying potential issues early, we help our clients reduce risk, increase confidence in data, and stay on track with development timelines.
What Advanced Instrumentation Does Emery Pharma Use?
Our lab is equipped with state-of-the-art instruments that ensure precision, sensitivity, and regulatory compliance across all analytical methods:
High-Resolution Mass Spectrometry (HR-MS): Thermo Orbitrap Exploris 240
Ideal for metabolite profiling, biomarker discovery, and impurity analysis, HR-MS enables detection of trace-level compounds with unmatched resolution. Essential for PK, bioavailability, and toxicology studies.
Triple Quadrupole LC-MS/MS: Agilent 6470
This platform offers high specificity and throughput for MRM-based quantification of drugs and metabolites in biological fluids. It’s a gold standard for regulated bioanalytical quantitation.
GC-MS System: Thermo ISQ-7000
Used for volatile and semi-volatile compound analysis, lipidomics, and environmental or toxicological screening. Offers high sensitivity and accuracy for analyzing small molecules and steroids.
400 MHz Multi-Nuclear NMR (GLP-Qualified)
NMR is applied when structural elucidation is needed or when standard MS detection isn’t viable. Particularly useful for biologics, impurity characterization, and drug-protein interactions.
Ligand Binding Assays (ELISA)
Our ELISA-based LBA platforms are optimized for detecting antibodies, proteins, and peptides. Frequently used in immunogenicity testing, ADA monitoring, and clinical biomarker analysis.
What Are the Challenges in Bioanalysis, and How Does Emery Pharma Address Them?
Bioanalytical method development is not without its hurdles. Challenges include:
- Matrix interference from complex biological samples
- Achieving sufficient sensitivity for trace-level detection
- Ensuring reproducibility and data integrity across sample runs
- Maintaining compliance with GLP and ICH M10 guidelines
At Emery Pharma, we address these challenges by:
- Customizing assay development to each client’s needs and sample types
- Employing rigorous sample preparation and cleanup protocols
- Conducting full method validation to meet global regulatory standards
- Leveraging decades of scientific expertise and cross-functional collaboration
What Regulatory Standards Does Emery Pharma Follow?
We prioritize regulatory compliance in every study, maintaining data quality and defensibility throughout:
- Good Laboratory Practice (GLP) – 21 CFR Part 58
- ICH M10 – Guidelines for bioanalytical method validation
- FDA, EMA, and ANVISA – Alignment with global regulatory authorities
Our validated methods and quality systems ensure that your data stands up to scrutiny—whether for IND, NDA, or BLA submission.
Who Does Emery Pharma Work With?
We proudly partner with organizations across the life sciences sector, including:
- Pharmaceutical and biotech companies
- Contract Research Organizations (CROs)
- Academic institutions and research hospitals
- Public health and government agencies
From first-in-human studies to long-term bioequivalence monitoring, we provide trusted data that supports sound scientific and regulatory decisions.
How Can I Learn More or Request a Proposal?
If you’re looking for an experienced partner in bioanalysis, we’d love to hear from you. Whether you need LC-MS/MS method development, ADA testing, or regulatory validation, we’re ready to support your next milestone.
Call us: 1-888-98-EMERY (36379) or +1 (510) 899-8814
Email: info@emerypharma.com
Request a proposal: www.emerypharma.com/contact/
At Emery Pharma, we’re committed to delivering accurate, GLP-compliant bioanalytical solutions that bring clarity and confidence to your drug development journey.
