Laboratory analysis of biological medicine
Your needs: to ensure a high level of quality for your biological medicine in accordance with relevant pharmaceutical standards
Biological medicines are medications with active ingredients taken from living sources. They differ from conventional medications as their active ingredients are not chemically synthesized.
Biological medicines encompass vaccines, therapeutic proteins and monoclonal antibodies which are often administered in the form of injectable drugs.
These biological medicines are subject to the same types of stringent regulations as conventional medicines. Many chemical analysis must therefore be carried out on these substances.
Compliance of biological medicines is critical for them to be able to go to market and is essential for their life cycle.
A poorly aging product, the presence of impurities, interactions between active ingredients and excipients… These scenarios all hinder a biological medicine’s chances of going to market and can cause them to be called back.
To overcome these technical challenges, you are looking to cooperate with a reliable and reactive analytical laboratory.
Our solution: to assist you in expertly analyzing your biological medicine and monitoring its quality
FILAB offers its high level of skill and its advanced technical know-how along with a cutting-edge analytical fleet to pharmaceutical industrialists by providing services fulfilling various compliance requirements. FILAB is the only laboratory in France to be ISO 17025 accredited (www.cofrac.fr accreditation n°1-1793) for carrying out analysis of elemental impurities found in pharmaceutical matrices.
From analysis to R&D, FILAB laboratory is able to provide its expertise to fulfil various types of requests relating to biological medicines :
- Chemical analysis of biological medicines using GC-MS, LC-MS, ICP…
- Detection of elemental impurities (ICH Q3D)
- Particulate analysis (troubleshooting) using SEM-EDX, FTIR, LC-MS/MS…
- Reverse engineering of biological medicines
- E&L testing
- Analytical development
- Validation of methods in accordance with ICH Q2
- Analysis of residual solvents found in pharmaceuticals in accordance with the ICH Q3D guideline
- Nitrosamine analysis
For more information about our analytical services relating to biological medicine, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05. You can also request a free quote online here.
