Dynamic light scattering is known as a fast and efficient screening method for aggregate / particle detection. It is widely used within biopharmaceutical development. DLS closes the gap between techniques like size exclusion chromatography (SEC), that measure small soluble aggregates and particle methods such as light obscuration (LO) or micro flow imaging (MFI). Due to a high sensitivity toward large species, even small impurities can be detected within the measurement range (0.5 nm – 1 µm). Please follow the link for more information.  

Sedimentation velocity analytical ultracentrifugation (SV-AUC) has the potential to become one of the most crucial techniques for evaluation of f adeno-associated virus (AAV) product quality. SV-AUC provides data on the ratio of DNA incorporation into virus capsids. Additionally, this technique gains information about the purity of a product in regard to aggregates and fragments. The importance of these findings makes SV-AUC one of the most powerful stability and quality indicating techniques in the field of gene therapy. Please follow the link for more information.

Asymmetrical flow field-flow fractionation (AF4), coupled with a multiangle laser light scattering detector (MALLS), has the potential to develop into a crucial technique for the evaluation of adeno-associated virus (AAV) product purity. It is already one of the main assays within several cases of gene therapy product development. Please follow the link for more information.

Size exclusion chromatography (SEC) is the most commonly used technique for aggregate determination in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility that this method provides. However, with the recent interest in gene therapy-based APIs the limitations of the technique must be considered. SEC features a limited size range toward larger species, depending on the column, and therefore poses a challenge when a specific method for AAV detection is developed. We are able to tackle that issue, using our experience and state-of-the-art analytical equipment. Please follow the link for more information.

Light scattering is a well defined effect. The physical properties of light scattering are used for several applications, such as dynamic and static light scattering. Please follow the link to a detailed description of light scattering theory. 

We are offering a wide range of analytical techniques for the determination of particle size distributions.  The detection of nano particle size distributions (1 nm  – 1 μm) is growing in importance. Especially, since the interest in gene therapy increased. Our scientist are working since more than 10 years on the topic of particle size determination. Please follow the link for more information.

Temperature stability testing is a crucial step in both biosimiliarity studies and formulation development. It is also a valuable tool in production optimization. With our setups we can support you either investigating the aggregation temperature or doing isotherm stability testings. If you need further information please follow the link. 

In the last couple of years, the interest in the determination of predictive parameters within formulation development has grown. Interactions parameters provide valuable information for the prediction of molecular stability. These values are used in a “design of experiment” (DOE) approach to assist formulation developments. Please follow the link for more information.