amsbiowp, Author at AMSbiopharma

Drug development timeline: how early characterization prevents regulatory delays

The modern drug development timeline is highly shaped by manufacturing readiness, analytical understanding, and regulatory alignment. While innovation in therapeutic modalities has accelerated target discovery, the path from laboratory research to approved medicine remains long and complex. In practice, advancing…

Chemistry, Manufacturing, and Controls (CMC) in the drug development process: analytical strategies to support Investigational New Drug (IND) readiness and regulatory progression

The transition from discovery to clinical evaluation represents one of the most critical inflection points in the drug development process. Central to this journey is the Chemistry, Manufacturing and Controls (CMC) framework, which ensures that every dose of an investigational…

Analytical strategies for gene and cell therapy products: From characterization to regulatory expectations

The rapid expansion of advanced therapies has transformed how medicines are designed, manufactured, and evaluated. Unlike traditional pharmaceuticals, advanced therapy products, such as those for gene and cell therapy, function through biological mechanisms that modify cellular behavior or genetic expression,…

EMA’s updated nitrosamines guideline: Implications for acceptable intake limits and analytical strategies

The landscape of impurity control in pharmaceutical manufacturing has been profoundly reshaped by the emergence of N-nitrosamines as potent mutagenic impurities. Since the initial discovery of NDMA in sartan-based products in 2018, regulatory bodies have continuously refined their expectations to…

Designing “fit-for-purpose” quality control protocols for biologics and nucleic acid therapeutics

The rapid maturation of nucleic acid therapeutics and complex biologics has necessitated a significant shift in the pharmaceutical quality paradigm. Traditional “one-size-fits-all” approaches are increasingly inadequate for modalities like messenger RNA (mRNA), antisense oligonucleotides, and viral vectors, where the structural…

Analytical cro for outsourcing as a biotech

Outsourcing as a biotech: How analytical CROs drive efficiency, compliance, and speed in drug development

The landscape of drug discovery and development has undergone a tectonic shift over the last decade. As the molecular complexity of new chemical entities (NCEs) and biologics increases, the traditional model of maintaining comprehensive, in-house analytical laboratories is becoming increasingly…

UPLC-MS/MS method submissions for peptides

Implementation of UPLC‑MS/MS workflows in peptide therapeutics: from method development to regulatory submission

Peptide therapeutics represent a rapidly growing segment of pharmaceutical pipelines, offering high specificity and potency. However, their bioanalysis poses unique challenges due to low concentration in complex biological matrices and structural instability. To overcome these hurdles, the industry is increasingly…

peptide stability requires specialized analytical methods

Analytical method development and stability-indicating strategies for synthetic peptide therapeutics under ICH regulatory frameworks

The pharmaceutical landscape is increasingly dominated by peptide therapeutics, which offer higher specificity and efficacy than small molecules. However, their complex chemical structures and inherent susceptibility to degradation present unique challenges in quality control. The transition of a synthetic peptide…

Challenges in Preclinical Research Partnerships

Preclinical Contract Research to Accelerate Drug Development: Study Design and FDA Toxicology Guidelines Considerations

Before a drug candidate reaches clinical testing, it must demonstrate safety and efficacy under controlled laboratory conditions. This early work, known as preclinical research, establishes whether a compound has a reasonable likelihood of success in humans. The quality and rigor…

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

Liquid chromatography coupled with tandem mass spectrometry (LC‑MS/MS) has become the reference technique for quantitative bioanalysis in drug development, pharmacokinetics, toxicology studies, and biomarker research. As regulatory expectations for sensitivity and reproducibility rise, laboratories increasingly turn to LC‑MS/MS to quantify…