Quantitative NMR (qNMR) stands as a robust method for gauging pharmaceutical purity. In the realm of analytical chemistry, nuclear magnetic resonance (NMR) spectroscopy emerges as a potent technique, offering insights into the structure, dynamics, and interactions of organic molecules while enabling quantitative measurements. A pivotal distinction from other methods lies in the direct proportionality between the integral of an NMR peak and the nucleus concentration. This unique feature positions NMR as a highly valuable tool for precise quantification. However, this potency is contingent upon ..read more

Method development and validation are essential components of drug development and chemistry manufacturing and controls (CMC). The goal of method development and validation is to  ensure that the methods used to measure the identity, purity, potency, and stability of drugs are accurate, precise, and reliable. Analytical methods are critical tools for ensuring the quality, safety, and efficacy of pharmaceutical products in the drug development process. Analytical development services performed at Emery Pharma are outlined below. Analytical Method Development Overview: Analytical method de ..read more

ADCs, short for antibody-drug conjugates, consist of three essential components: a monoclonal antibody (mAb), a linker molecule, and a small molecule drug. In simple terms, an ADC is created by joining an antibody (mAb) with a drug through a linker or spacer. The linker is a chemical bridge that attaches the drug to the antibody, usually at specific sites like lysine or cysteine residues. The drug connected to the antibody is commonly referred to as the “payload.” For instance, in the realm of oncology therapeutics, the antibody is designed to target antigens that are abundantly present on the ..read more

Cancer is a complex disease that requires a multifaceted approach to treatment in order to prevent regression. In the past, traditional treatments in oncology have consisted of small molecule cytotoxic drugs (alkylating agents, antimetabolites, etc.), and recently, more targeted therapies like tyrosine kinase inhibitors (TKIs), monoclonal antibodies (mABs), antibody-drug conjugates (ADCs), bi-specific T cell engagers (BITEs), etc. However, resurgence of a previously underutilized field of cancer therapy has been making a comeback: microbial-based therapies, aka “bugs as drugs.” Bacteria have a ..read more

Method development and validation are essential components of drug development and chemistry manufacturing and controls (CMC). The goal of method development and validation is to  ensure that the methods used to measure the identity, purity, potency, and stability of drugs are accurate, precise, and reliable. Analytical methods are critical tools for ensuring the quality, safety, and efficacy of pharmaceutical products in the drug development process. Analytical development services performed at Emery Pharma are outlined below. Analytical Method Development Overview: Analytical method de ..read more

Intact Mass and Subunit Fragment Analyses The LC-MS analyses of the intact and subunit biologic molecules are simple analyses which characterize detailed modifications of complex molecules.  This information-rich study is useful throughout the product development cycle, from research to commercialization, including GMP product release, comparability, and characterization studies. Indeed, the consistency of drug production is supported by the consistency of intact mass results throughout the project lifetime. The intact LC-MS analyses may also be utilized as an ID test in commercial relea ..read more

In this video we provide an overview of the European Food Safety Authority's guidance on antimicrobial testing of microbes used in animal feed. Slide 1: Hello everyone! My name is Dr. Janet Liu, and I am the Director of Microbiology at Emery Pharma. Today I will be giving a brief overview of the European Food Safety Authority’s guidance on antimicrobial susceptibility testing of microbes used in animal feed. Slide 2: Within the European Union the ESFA is the agency responsible for providing advice, risk assessment, and guidance on matters related to the food supply chain. EFSA has created a s ..read more

Emery Pharma presented this work at the 68th American Society for Mass Spectrometry (ASMS) Conference in June, 2020. Here, in this video, we presented the overview of the method for trace-level quantitative analysis of Poloxamers in biological samples by HPLC-ESI-QqQ MS. The developed method is based on a robust LC-MS/MS (MRM)-based approach and a simple protein precipitation-based sample preparation protocol to address challenges with quantification of trace amounts of this polymer in a variety of biological matrices. The analytical performance of the method, including specificity, lin ..read more

Emery Pharma, presented this work at the 68th American Society for Mass Spectrometry (ASMS) Conference in June, 2020. Ranitidine, a H2 histamine receptor blocker, is extensively used for heartburn and other stomach acid-related diseases. Recently, detection of the probable human carcinogen, N-Nitrosodimethylamine (NDMA), as an impurity resulted in extensive recalls of ranitidine medicines. We played an instrumental role in this discovery and showed that ranitidine is an inherently unstable compound, spontaneously forming NDMA at higher temperatures. Thermal instability of ranitidine limits t ..read more

Cancer is a complex disease that requires a multifaceted approach to treatment in order to prevent regression. In the past, traditional treatments in oncology have consisted of small molecule cytotoxic drugs (alkylating agents, antimetabolites, etc.), and recently, more targeted therapies like tyrosine kinase inhibitors (TKIs), monoclonal antibodies (mABs), antibody-drug conjugates (ADCs), bi-specific T cell engagers (BITEs), etc. However, resurgence of a previously underutilized field of cancer therapy has been making a comeback: microbial-based therapies, aka “bugs as drugs.” Bacteria have a ..read more