Biomarker Discovery: Leveraging Cell-Based Assays
Cell-based assays are vital for understanding cellular responses to drugs, environmental factors, and genetic changes, making them crucial for drug development, toxicity testing, and biomarker discovery. At Emery Pharma, we…
Antibody Drug Conjugates (ADCs): A Powerful Approach to Targeted Cancer Therapy
Antibody Drug Conjugates (ADCs) represent an innovative class of targeted cancer therapies that combine the specificity of antibodies with the potency of cytotoxic drugs. By delivering chemotherapeutic agents directly to…
Bridging Study: Comparing QQQ and HRMS for Impurity X Quantitation, determining their regulatory alignment, and evaluating method transfer feasibility
In pharmaceutical analysis, selecting the right instrumentation is critical for ensuring precise and regulatory-compliant impurity quantitation. At Emery Pharma, we conducted a bridging study to compare two mass spectrometry techniques—Triple…
An Overview of Nitrosated Drug Substance Related Impurities (NDSRIs)
Nitrosamines in Drug Substance (DS) In 2018 health authorities became aware of the nitrosamine N-nitrosodimethylamine (NDMA) in valsartan drug substance. The investigations expanded, NDMA and other potent nitrosamines were found…
The Critical Role of Bioanalytical Platform Selection: Ligand-Binding Assays vs Mass Spectrometry
The selection of a bioanalytical platform is critical because it directly influences the accuracy, sensitivity, and specificity of the data generated, which in turn guides decision-making in drug development. A…
Countdown to Compliance: The August 2025 Deadline for NDSRI Testing Looms Over Pharmaceutical Industry
As the pharmaceutical industry approaches the crucial deadline of August 2025, manufacturers of both currently marketed and newly approved drug products are under increasing pressure to evaluate and control the…
Antimicrobial Textiles Testing
Humans have been weaving textiles and fashioning clothing from fabrics for thousands of years, but one of the great challenges since the dawn of civilization has been the degradation and…
Ensuring Quality and Efficacy of GLP-1 Agonists: Analytical Challenges and Solutions in Therapeutic Peptide Production
Glucagon-like peptide-1 (GLP-1) agonists represent an exciting class of drugs that have gained significant attention in recent years for their potential to treat type 2 diabetes mellitus (T2DM) and obesity….
Antibody Drug Conjugates Q&A: A Novel Approach to Drug Delivery in Oncology
What is an antibody drug conjugate? An antibody drug conjugate, or ADC, is a drug modality that consists of three main components: an antibody, a linker, and a drug, often…
Native Mass Spectrometry (Native-MS) for Aggregate and Charge Variant Analysis
Size exclusion chromatography (SEC) and ion exchange chromatography (IEX) are traditional methods utilized for characterizing biotherapeutics under non-denaturing conditions. The typical high salt concentrations in their mobile phases make them…