Optimizing LC‑MS/MS Sensitivity: Strategies to Overcome Ion Suppression and Boost Robustness in Bioanalysis

by AMSbiopharma

7 months ago
Liquid chromatography coupled with tandem mass spectrometry (LC‑MS/MS)

This article explores how advanced LC‑MS/MS instrumentation and refined method development approaches can overcome these hurdles, enhancing data quality and operational reliability in bioanalytical ...

Application of Biomarkers in Bioanalytics: Enabling Translational Development in Pharmaceutical R&D

by AMSbiopharma

7 months ago
Biomarkers, Bioanalytics

In bioanalytical workflows, biomarkers serve as quantifiable proxies for biological processes, disease states, or therapeutic responses. Still, the rapid evolution of drug discovery and clinical devel...

Mass Spectrometry in GMP Environments: Enhancing QC and Compliance in Drug Development

by AMSbiopharma

7 months ago
Mass Spectrometry, Good Manufacturing Practice (GMP)

Applications of mass spectometry extend far beyond its original role in molecular weight determination. Today, its use span the entire drug development lifecycle, from discovery and preclinical profil...

AMSbiopharma completes its Innovation Plan, supported by Innova Pyme, achieving progress in services, technology, and entrepreneurial culture

by AMSbiopharma

8 months ago
AMSbiopharma, Innova Pyme 2024 program

This initiative strengthens the company’s competitive position in the global biopharmaceutical sector by leveraging intangible innovation, implementing new quality protocols, promoting intrapreneurs...

Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance

by AMSbiopharma

8 months ago
Drug Impurity

Impurity profiling integrates advanced analytical techniques with regulatory frameworks to detect, identify, and quantify these substances, supporting the production of compliant and high-quality medi...

Pharmacokinetics and Pharmacodynamics (PK/PD) Studies in Drug Development: From ADME Principles to Translational Applications

by AMSbiopharma

9 months ago
Pharmacokinetics and Pharmacodynamics (PK/PD)

Pharmacokinetics describes the journey of a drug through de body, covering absorption, distribution, metabolism, and excretion (ADME). This trajectory determines the concentration of the drug in the b...

Pharma Quality Control Strategies for Drug Development and Regulatory Compliance

by AMSbiopharma

9 months ago
Drug Development, Pharma Quality Control

As drug candidates move from early research through commercial production, robust pharma quality control strategies become the backbone of safe, effective, and regulatory-compliant medicines. The inte...

Preclinical Research in Drug Development: From Toxicology to Translational Insights

by AMSbiopharma

9 months ago
Investigational New Drug (IND), Drug Development, Pharmacokinetics and pharmacodynamics (PK/PD), Proof-of-concept (POC)

Through a series of well-established scientific assessments, ranging from toxicology assessments to pharmacokinetics and efficacy models, preclinical research generates essential data to support Inves...

ICH Guidelines for Analytical Method Validation: Principles, Requirements and Industry Applications

by AMSbiopharma

11 months ago
ICH Q2(R2), Q14

In pharmaceutical development, validating analytical methods goes further than regulatory formality. It is a critical component of ensuring reliable, reproducible, and scientifically sound data. The I...

ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development

by AMSbiopharma

11 months ago
ICH Q3 Impurity Guidelines

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 Harmonisa...

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

by AMSbiopharma

11 months ago
LC-MS/MS and UPLC-MS/MS Applications, Drug Development

Analytical method development in drug discovery refers to the process of designing, optimizing, and validating analytical techniques that can accurately characterize a drug candidate before it enters ...

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

by AMSbiopharma

1 year ago
Biologic Drugs, Biotechnology

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 thera...