QC — Quality Control
Analytical services for the characterisation, testing and quality assurance of drug substances and pharmaceutical products.
Analytical quality control is one of the most critical functions in pharmaceutical development and manufacturing. The ability to demonstrate, through precise, reproducible and properly documented analytical data, that a drug substance or pharmaceutical product meets its defined quality specifications is a non-negotiable regulatory requirement that underpins patient safety and the commercial viability of the product.
AMSbiopharma offers a broad portfolio of analytical quality control services for drug substances and pharmaceutical products at all stages of development, from the first CMC characterisation studies through to the generation of the analytical data that support batch release in regulated manufacturing environments. Our services cover a wide range of the analytical testing requirements for the characterisation and control of pharmaceutical products, applying validated methods compliant with pharmacopoeial standards and the requirements of regulatory authorities.
Our laboratory operates under a quality management system aligned with the principles of Good Manufacturing Practice (GMP/BPF), with controlled procedures, complete data traceability and documentation compliant with the data integrity requirements of the EMA and the FDA. This quality foundation ensures that the analytical data generated by AMSbiopharma may be suitable for use in regulatory dossiers and in the quality control decision-making processes of our clients.
What does analytical quality control cover?
Analytical support in R&D covers a broad spectrum of needs that evolve as the programme advances. In the earliest stages, the focus is on the chemical and structural characterisation of the candidate compound, evaluation of its physicochemical properties and determination of its stability profile in relevant matrices.
As the programme progresses towards preclinical studies, analytical support expands to include quantification of the drug and its metabolites in biological matrices from animal species, analysis of response and safety biomarkers, and characterisation of pharmacokinetic and pharmacodynamic interactions. All of this information provides the knowledge base needed to take well-founded decisions on candidate progression.
CMC development and regulatory documentation support
An essential part of the quality control support provided by AMSbiopharma is oriented towards CMC development (Chemistry, Manufacturing and Controls): the generation of the analytical data needed to build the product quality dossier that underpins regulatory submissions to the EMA, the FDA and other authorities.
This includes analytical method development and validation in accordance with ICH Q2(R2), stability studies in accordance with ICH Q1, impurity profiling and characterisation in accordance with ICH Q3A and ICH Q3B, and the generation of the characterisation data for the pharmaceutical product and drug substance required for the analytical sections of marketing authorisation dossiers.
Modalities and therapeutic areas
AMSbiopharma’s quality control services cover all pharmaceutical modalities: small molecules, therapeutic peptides, oligonucleotides, biologics — including monoclonal antibodies, therapeutic proteins, biosimilars and vaccines — and advanced therapy products. This cross-cutting coverage enables us to offer coherent, integrated quality control support for pharmaceutical portfolios of any composition.
The breadth of available testing — from assay determination by HPLC/UHPLC and characterisation by high-resolution mass spectrometry to microbiological testing for bacterial endotoxins and bioburden — enables AMSbiopharma to address the analytical quality control needs of a wide range of product types and development stages.
To learn more about our quality control capabilities and the specific scope of our services for your programme, we invite you to contact our team.