amsbiowp, Author at AMSbiopharma

ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development

Impurities in pharmaceuticals can compromise the safety, efficacy, and stability of a product. To safeguard public health, global regulatory authorities such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established frameworks to…

Analytical method and analythical priorities

Analytical Priorities in Drug Development: How Preclinical Data Shapes Regulatory Success

The preclinical research phase in the drug development process involves the extensive evaluation of candidate compounds before clinical trials. Through a combination of in vitro, in silico, in chimico, and/or in vivo studies, researchers assess the pharmacological activity, safety, and…

Quality control in biotechnology: ensuring GMP compliance in the biologics manufacturing process with HPLC

Quality Control in Biotechnology: Ensuring Safety in the Biologics Manufacturing Process

The use of biologics has grown exponentially in the last decade, driven by advances in genetic engineering, a deeper understanding of disease mechanisms, and an increasing demand for targeted therapies with fewer side effects. These treatments, developed from living organisms,…

ICH Q3E Guideline: Impurities Assessment and Control

The safety and efficacy of pharmaceutical products largely depend on controlling impurities in their formulations. Therefore, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed various guidelines, with the upcoming ICH Q3E guideline…

the ICH guidelines for drug stability testing explained

ICH Guidelines: Drug Stability Testing Essentials

What Are ICH Guidelines? The ICH, a non-profit international organization founded in 1990, developed the ICH guidelines as scientific consensus documents. The ICH guidelines full form stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human…

Advanced Analytical Methods in Detecting Impurities in OZEMPIC

Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies

Semaglutide has emerged as a groundbreaking therapy for managing type 2 diabetes, marketed under brand names like Ozempic. As a glucagon-like peptide-1 (GLP-1) receptor agonist, it significantly benefits glucose regulation and weight management. Its patent is set to expire…

Peptide Drugs: Discovery and Development Explained

What Are Peptide Drugs and How Are They Used in Therapeutics? Peptide drugs, also known as therapeutic peptides, are short chains of amino acids, typically consisting of molecular weights of 500-5000 Da. These molecules are designed to mimic natural peptides…

Application of Hydrophilic Interaction Chromatography (HILIC) in pharmaceutical analysis

Analyzing polar compounds via high-performance liquid chromatography (HPLC) has long posed a challenge due to their limited retention on reverse-phase stationary phases, the most widely used in laboratories. To increase the retention of these compounds in reverse phase, ion-pairing chromatography…

How to Manage Nitrosamine Contamination in Active Pharmaceutical Ingredients

In 2018, the detection of nitrosamines in sartan-type drugs, medications to treat high blood pressure and heart failure, set off all the alarm bells. The presence of N-nitrosodimethylamine (NDMA) in Valsartan was the first indication. Later appearances of other nitrosamines…

ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development

Analytical Priorities in Drug Development: How Preclinical Data Shapes Regulatory Success

Quality Control in Biotechnology: Ensuring Safety in the Biologics Manufacturing Process

ICH Q3E Guideline: Impurities Assessment and Control

ICH Guidelines: Drug Stability Testing Essentials

Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies

Peptide Drugs: Discovery and Development Explained

Application of Hydrophilic Interaction Chromatography (HILIC) in pharmaceutical analysis

How to Manage Nitrosamine Contamination in Active Pharmaceutical Ingredients

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