amsbiowp, Author at AMSbiopharma

AMSbiopharma becomes the first analytical services laboratory in Galicia with GMP Certification for medicinal product quality control activities

The Spanish Agency for Medicines and Medical Devices certifies compliance with Good Manufacturing Practices at the Lugo-based laboratory specialising in advanced analytical services AMSbiopharma, an advanced analytical CRO (Contract Research Organization) specialising in services for the pharmaceutical, biopharmaceutical and chemical…

ASO analytical characterization by LC-MS

Antisense oligonucleotide analysis by mass spectrometry: sequence confirmation, impurity profiling and CRO support for regulatory submission

Every antisense oligonucleotide (ASO) drug candidate carries a structural burden that small molecules never face: a polyanionic backbone, a defined sequence that must match its design exactly, and a synthesis process that generates impurities differing from the target by as…

AMSbiopharma will be exhibiting for the first time with its own stand at Farmaforum 2026

Farmaforum, the leading national event for the biotechnology and pharmaceutical sector, will take place on 22 and 23 September at the IFEMA exhibition centre in Madrid, Hall 10. Farmaforum 2026 will hold its twelfth edition on 22 and 23 September…

Bioequivalence studies in drug development: study design, bioanalytical methods and regulatory compliance

Two formulations of the same active ingredient rarely behave identically in the body, and drug development depends on saying, with statistical confidence, when that difference is small enough to ignore. The bioequivalence study is the pharmacokinetic tool that makes this…

molecular characterization with high-resolution mass spectrometry

Mass spectrometry services for small molecule drug characterization: structural analysis, metabolite identification, and CRO support

Every small-molecule drug candidate must clear two analytical hurdles before it reaches a regulatory filing: confirmed chemical identity and a defined metabolic fate once dosed in a biological system. Both depend on mass spectrometry (MS) applications spanning structural confirmation, impurity…

Hit-to-lead in drug discovery: analytical strategies for hit validation and lead optimization

Every small-molecule program begins with a deceptively simple question: Does this compound actually bind the target, and can it become a drug? Turning a screening signal into a molecule worth advancing is one of the most consequential inflection points in…

Gas chromatography-mass spectrometry (GC-MS) in drug development: pharmaceutical applications and regulatory compliance

Since the 1980s, gas chromatography has served as a stability-indicating technique for pharmaceutical products, and gas chromatography mass spectrometry (GC-MS) extended that role to trace-level identification of volatile and semi-volatile impurities that concern regulators most today, from residual solvents to…

Peptide mapping for biopharmaceutical characterization: LC-MS/MS workflows, PTM analysis, and ICH Q6B compliance

Structural complexity is one of the defining challenges of biopharmaceutical development. Unlike small-molecule drugs, large protein therapeutics (monoclonal antibodies, fusion proteins, peptide therapeutics, and biosimilars) are heterogeneous by nature, subject to a wide range of post-translational modifications that can influence…

Host cell protein detection in biologics: LC-MS/MS strategies for HCP clearance and regulatory compliance

Every biopharmaceutical produced in a living cell system carries an unavoidable burden: the proteins expressed by the host cell itself. These process-related impurities in biologics are present from the earliest stages of fermentation and must be systematically characterized, monitored, and…

ICH Q11 drug substance development strategies

ICH Q11 development and manufacture of drug substances: analytical and process strategies for robust CMC principles implementation

Drug substance development sits at the foundation of every pharmaceutical program, yet it is often where the most consequential analytical and regulatory decisions are made with the least systematic rigor. The ICH Q11 development and manufacture of drug substances guideline,…