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 drug 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 blood, serum, plasma, urine, and tissue samples. It is essential in drug development because it helps:

• Determine how the body processes a drug (pharmacokinetics, PK)
• Assess how the drug interacts with the body (pharmacodynamics, PD)
• Ensure appropriate dosing, efficacy, and safety

Without accurate bioanalysis, drug candidates could face delays, safety concerns, or regulatory hurdles, making bioanalysis a critical component of the drug approval process.

What Bioanalytical Services Does Emery Pharma Offer?

Emery Pharma provides a comprehensive suite of bioanalytical services, including:

• LC-MS/MS-based quantitation of small molecules, peptides, and biologics
• Method development (de novo and customized)
• Method validation (qualification and GLP-compliant validation per ICH M10 guidelines)
• Sample analysis and study design
• Sample cleanup and preparation
• In vitro ADME, PK, and TK studies using LC-MS/MS and HR-MS assays
• Ligand Binding Assays (LBA) for anti-drug antibody (ADA) detection

Our services support the entire drug development lifecycle, from discovery and preclinical research to clinical trials and regulatory submissions.

What Stages of Drug Development Does Emery Pharma Support?

Emery Pharma supports all stages of drug development, including:

• Discovery & Preclinical Research – Early-stage compound characterization
• Clinical Trials (Phase I, II, III) – PK/PD analysis and regulatory compliance
• Regulatory Submissions – Assay validation for FDA, EMA, and other regulatory agencies

By addressing bioanalytical challenges early, we help clients avoid costly delays and regulatory setbacks.

What Advanced Instrumentation Does Emery Pharma Use for Bioanalysis?

We use state-of-the-art analytical instruments to ensure accuracy, sensitivity, and regulatory compliance:

High-Resolution Orbitrap Mass Spectrometry (HR-MS)-Thermo Orbitrap Exploris 240 

HR-MS enables precise quantification, structural elucidation of metabolites, biomarker discovery, impurity profiling, and drug metabolism analysis. It detects trace-level compounds with high specificity, supporting PK, bioavailability, and toxicology studies.

Triple Quadrupole LC-MS/MS-Agilent 6470 Triple Quad LC MS

This system offers high sensitivity and selectivity for quantifying drugs, metabolites, and biomarkers in biological matrices like plasma and urine. The MRM mode ensures precise quantification, making it a standard for PK, drug metabolism, and regulatory compliance studies.

GC-MS System-Thermo – Single Quad ISQ-7000

GC-MS is ideal for detecting volatile and semi-volatile compounds, widely used in drug metabolism, toxicology, lipidomics, environmental exposure studies, and forensic analysis. It provides high sensitivity and specificity for analyzing small molecules, fatty acids, steroids, and drug metabolites.

400 MHz Multi-Nuclear NMR (qualified for cGMP and GLP use)

NMR is employed in unique cases where a metabolite signal can be isolated and detected. It is highly useful for structural elucidation, drug-protein interactions, stability studies, metabolomics, biologics characterization, and impurity detection.

This advanced instrumentation allows us to detect and quantify even trace amounts of compounds in complex biological matrices.

Ligand Binding Assays (ELISA)

LBA platforms allow quantification of proteins, peptides, and antibodies in pharmacokinetics, immunogenicity testing, and biomarker detection. ELISA platforms provide high sensitivity and specificity, making them essential for biologics characterization and clinical studies.

What Are the Challenges in Bioanalysis, and How Does Emery Pharma Address Them?

Bioanalysis presents several key challenges, including:

• Developing robust methods to minimize interference from biological matrices
• Handling complex biological samples with diverse metabolic backgrounds
• Optimizing assays to achieve high sensitivity and specificity
• Ensuring regulatory compliance with GLP and ICH M10 guidelines

At Emery Pharma, we overcome these challenges through:

• Custom method development tailored to client needs
• Expertise in complex sample analysis for accurate and reliable results
• Regulatory-compliant validation to meet global standards
• A dedicated team of scientists committed to bioanalytical excellence

What Regulatory Standards Does Emery Pharma Follow?

We adhere to the highest industry standards, ensuring data integrity and regulatory compliance. Our work follows:

• Good Laboratory Practice (GLP) guidelines (21 CFR Part 58)
• ICH M10 bioanalytical method validation guidelines
• FDA, EMA, and ANVISA regulatory requirements

By maintaining these rigorous standards, we ensure high-quality, regulatory-compliant bioanalytical data to support drug development and approval.

Who Does Emery Pharma Work With?

We collaborate with a diverse range of clients, including:

• Pharmaceutical and biotechnology companies
• Contract Research Organizations (CROs)
• Academic research groups
• Government agencies

Our clients rely on Emery Pharma’s expertise to generate accurate, high-quality bioanalytical data for drug development and regulatory submissions.

How Can I Learn More or Request a Proposal?

If you’re looking for expert bioanalytical support, we’re here to help. Contact us through:

Phone: 1-888-98-EMERY (36379) or +1 (510) 899-8814 (international)
Email: info@emerypharma.com
Website: emerypharma.com

At Emery Pharma, we’re committed to delivering precise, high-quality bioanalytical solutions to help bring your drug candidates to market efficiently and successfully. Please see our other videos here or contact us today to see how we can support your bioanalytical needs!