amsbiowp, Author at AMSbiopharma

Mass Spectrometry in GMP Environments in Drug Development

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

In today’s highly regulated biopharmaceutical landscape, ensuring quality, safety, and efficacy across the drug development lifecycle is both a scientific imperative and a regulatory mandate. As therapies become more complex, traditional analytical tools are often challenged by demands for higher…

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

AMSbiopharma presented today, in an online event, the results of its Innovation Plan, developed over the past 18 months with the support of the Galician Innovation Agency (GAIN) through the Innova Pyme 2024 program. This initiative strengthens the company’s competitive…

Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance

Ensuring the safety, efficacy, and quality of pharmaceutical products requires a thorough understanding of the impurities that may be present throughout the development and manufacturing process. These impurities, even at trace levels, can compromise therapeutic performance or pose risks to…

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

Understanding how a drug behaves in the body and how it exerts its therapeutic effects is essential for developing safe and effective treatments. From early discovery to regulatory approval, pharmacokinetics (PK) and pharmacodynamics (PD) are core disciplines that help characterize…

Quality Control and Regulatory Compliance

Pharma Quality Control Strategies for Drug Development and Regulatory Compliance

In pharmaceutical development, ensuring that products consistently meet predefined standards of identity, strength, purity, and quality it’s essential. As drug candidates move from early research through commercial production, robust pharma quality control strategies become the backbone of safe, effective, and…

Preclinical Research in Drug Development: From Toxicology to Translational Insights

Before a new compound can be administered to humans, it must undergo a rigorous process to ensure its safety, efficacy, and pharmacological profile. This process begins with preclinical research, a critical phase in the drug development process that bridges the…

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

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 ICH guidelines method validation framework, updated through ICH Q2(R2) and the complementary Q14 guideline on…

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,…

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

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

Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance

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

Pharma Quality Control Strategies for Drug Development and Regulatory Compliance

Preclinical Research in Drug Development: From Toxicology to Translational Insights

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

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

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