Stability & Release Testing

Eurofins BioPharma Product Testing laboratory network supports you in all relevant stability and release testing for your pharmaceutical product as well as clinical trial material.

Human medicinal and veterinary products, bulk products, and biological products can be stored and we are one of a few to have a license to store narcotics (§ 3 Betäubungsmittelgesetz (BtMG)).

Our expertise in ICH stability studies covers both small molecules and large molecules. Small molecules refer to conventional, low-molecular-weight drugs, while large molecules include proteins, peptides, monoclonal antibodies, and other biopharmaceuticals. The challenges associated with stability studies for large molecules differ from those of small molecules, requiring specialized knowledge and techniques. Our team of experts possesses in-depth understanding and experience in handling both types of molecules, ensuring reliable and accurate results.

We offer you the capacity as well as all options to test your substance, product or in-process materials within the specified time frame. In addition to those already mentioned we have experience in testing over-the-counter (OTC) products, packaging and excipients as well as raw materials.

We test materials for identity and content, any contamination, physical properties and safety in compliance with cGMP guidelines. In addition, we customize our processes to meet their requirements to make laboratory documentation, reporting and data delivery as efficient as possible and ensure high quality.

Our laboratory operations are designed to provide capacity for release testing while flexible accommodating smaller programs in a way that also enables extremely short cycle times.

ICH Stability Studies for small molecules & large molecules

Our equipment: The full instrument list

Stability testing and Storage systems / Capacity

• More than 322,000 cubic feet of storage space in more than 400 chambers, including ATEX chambers
• More than 25 different set points for the stability chambers including conditions recommended in the ICH guidance
• Full redundancy on critical systems

Storage conditions Eurofins BioPharma Product Testing network of laboratories worldwide: