What we do
Based on our extensive experience we focus on the analytics that matter and we help you to connect the dots for your product across all aspects of your analytical needs
Pre-Clinical & Clinical
Transferring your identity, purity, quantity, potency & general quality methods for your drug substance & drug product into a controlled, GMP-compliant environment.
Supporting phase specific validation throughout all phases of development (Phase I - III) & commercialization (Phase IV).
Covering all ICH validation parameters, according to Q2(R1) such as specificity, linearity, LOQ/LOD, range determination, accuracy, precision & robustness.
Taking into consideration:
critical reagents handling & bridging approaches.
establishment of reference & reference standard handling including storage.
Providing a comprehensive validation protocol, report & validated method.
Our testing capabilities
AnaBioTec is an independent Belgian-based analytical service provider focusing on Small molecules, Biologics, Biosimilars, Cell & Gene Therapy solutions.
AnaBioTec is committed to Good Manufacturing Practices in accordance with EudraLex – Volume 4 Good Manufacturing Practice (GMP), Directive 2003/94/EC and directive 91/412/EEC and FDA 21CFR part 210-211, 21CFR part 820).
Our Quality Policy stands to achieve the highest attainable level of quality in the provided analytical services to the pharmaceutical, biopharmaceutical, cell & gene therapy industry. These services include laboratory activities, reporting, project management and scientific/regulatory advice throughout the drug development process. The analytical services range from preclinical studies to release of product batches for patient supply. Through continuous process optimization, standardisation and quality trainings of all employees we aim at exceeding customer expectations. In agreement with our customers and depending on the phase of drug development, our quality mindset is sufficiently flexible to find the right balance between good analytical practices and risk-based decision making.
The independent Quality Assurance team, lead by the Corporate Head of QA is responsible to oversee and promote quality achievement, to ensure compliance of the quality systems with applicable (inter)national standards and legislation, to define quality policies and procedures, to set up and maintain control of documentation and to contribute to both internal and external audits.
As the EU regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP) ensuring that the batch is in accordance with the relevant requirements (EudraLex, Volume 4, Chapter 1), a QP is part of the AnaBioTec team offering the possibility for EU release for your clinical supplies and/or marketed products.
A state-of-the-art facility delivering tomorrow’s results, today