Our services
To support the further journey of your biologic drug substance to a drug product, the Eurofins CDMO in-house R&D and GMP analytical departments offer – in addition to the formulation screening services – a versatile toolbox of analytical techniques to ensure exceptional quality and regulatory compliance.
Advanced Analytical Techniques
At Eurofins CDMO, we pride ourselves on our cutting-edge analytical capabilities. Our laboratory is outfitted with the latest technology to perform a wide array of precise analyses for analytical development and validation.
Our services by means of this toolbox include:
- Formulation development support (Excipient compatibility support, content uniformity support, …)
- Forced degradation studies and Photostability on Drug Product
- Stability studies
- Profound scientific investigations to ensure the correct identity and dosage of the biological compound
Shelf-life Prediction & Safety
Our laboratories are at the forefront of conducting in-depth stability and excipient compatibility studies. These critical analyses, including Accelerated and ICH Stability Studies across various climatic zones, are pivotal in predicting the shelf-life and ensuring the safety and efficacy of drug products.
In addition to conventional real-time stability studies, we can also predict the long term stability by means of mathematical accelerated stability assessment tools applied on short term incubations at elevated temperatures and humidity conditions.
Discover how our specialized drug product analytical services can advance your pharmaceutical development and quality control processes.
R&D pre-validation and Transfer to GMP QC for validation
When all methods in scope are developed and optimized, then these are subjected to an R&D pre-validation. This R&D pre-validation has several intentions:
- Demonstrating confidence in the methods for further usage in the R&D environment (e.g. for R&D accelerated stability studies).
- De-risking and facilitating the transfer of methods from our R&D entity to our GMP QC entity for subsequent validation, release and stability testing activities in a GMP environment, ensuring timelines are kept.
Discover our Services