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Zentriforce Pharma Research GmbH 2019 – all rights reserved
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is the gold standard in aggregation analytics. The importance of SV-AUC results is growing, especially in biosimilarity studies, and also within the development of gene therapy products. ZentriForce Pharma offers SV-AUC services for a wide sample spectrum. For more information please follow the link.
Dynamic light scattering is a well-established analytical technique in the field of AAV development. Its primary use is to test for aggregate formation. Due to its high sensitivity towards large species, even small impurities caused by aggregation can be detected. We apply our dynamic light scattering instrumentation to determine particle size distributions. Additionally, we use this technique to provide information on thermal stability. 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.
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.
AUC is a first principle method. Therefore, the separation mechanism is well understood and extensively described. Please follow the link to a detailed description of AUC theory.
Even though SV-AUC is with its more than 100 years of history a by far older technique than most others currently used within biopharmaceutical development. It is one of the most complex in regards of data evaluation. We have setup our own supercomputer cluster to be able to offer you several different data evaluation approaches, without the need of your data leaving our premises. We currently offer Sedfit and Ultrascan data evaluations. However, if we see the need to use a different software for your very molecule we have the knowledge base to do so. Please follow the link for more information.
The detection of soluble aggregates is a crucial step for a wide range of bio-pharmaceutical products. It can be seen as one of the most important quality parameter, independent of the type of material you want us to analyze for you. if you have a gene therapy, a proteinaceous or an oligonucleotide based product. We can offer a We are offering a wide range of analytical techniques for the determination of soluble aggregates. We can support you with finding the best technique to determine the amount of soluble aggregates as well as their characterization. We also have a specialized web page on this very topic. Please follow the link for more information.
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.
ZentriForce Pharma was founded as a service provider that specializes in hydrodynamic techniques for biopharmaceutical development. The focus lies on gene therapy products and biosimilarity studies. Follow the link to our company page for further information.
ZentriForce Pharma implemented a strict quality system to assure the highest tractability of results generated at our facility. We have a wide range of quality related standard operation procedures (SOPS) in place to assure the consistency and quality of our laboratory operations. Please follow the link to a description of our quality system.
ZentriForce Pharma is your expert in analytical services, with focus on hydrodynamic techniques. Please follow the link to find out about our analytical services.
ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio.
ZentriForce Pharma is not merely an expert in analytical development. Our scientist are actively involved in further advances in the theory of hydrodynamic techniques. Follow the link to a detailed description of the theory behind our analytical services, including some of our own research
ZentriForce Pharma is always looking for motivated employees. Check out our career page for further 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.
Further applications of SV-AUC measurements include collection of data such as molecular weight, UV signal ratio 260 nm / 280 nm, sedimentation coefficient and shape of the observed species.
Please follow the link to our SV-AUC theory page to learn more.
Our AUC-experienced scientists have worked with a wide range of AAV samples. Our knowledge in AUC method development enables us to provide methods featuring both, highest quality results and maximum throughput of up to 14 samples per run. Consequently, we can assure you to keep the cost of sample analysis as low as possible.
Our ability to perform high resolution and high throughput measurements is due to our state-of-the art instrumentation. We carry out all measurements on the new Optima Analytical Ultracentrifuge and offer high quality data evaluation approaches, such as Ultrascan data evaluation. Our computer cluster allows us to perform all data evaluation at our own facility.
The Optima Analytical Ultracentrifuge further enables us to collect two different UV Signals (e.g. 260 and 280 nm), a feature that is especially useful for species characterization of AAV samples.
We are aware that all SV-AUC measurements are already relevant for either, your regulatory submissions or your production optimization. We have implemented a strict quality system to guarantee that the quality and traceability of all SV-AUC data is ensured. A wide range of quality related standard operating procedures (SOPs) in place. Our quality manager supervises employee trainings and correct documentation and ensures that scientists reliably follow all rules and instructions laid out within quality documents.
Additionally, we initiated a cooperation with the software and hardware developers to be able to provide GMP conform AUC measurements within the coming years.
We invite all (potential) costumers to audit our facility, our quality system and the data we collect for them. Please follow the link for a detailed description of our quality system.
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is seen as the gold standard for aggregation analytics. The importance of SV-AUC results is growing especially in biosimilarity studies as well as the development of gene therapy products. ZentriForce Pharma offers SV-AUC services for a wide range of samples. For more information please follow the link.
Dynamic light scattering is a well-established analytical technique in the field of AAV development. It is primarily used to test for aggregate formation. Due to its high sensitivity towards large species, even small impurities of aggregates can be detected within the measurement range of 0.5 nm to 1 µm. 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 have to be considered. SEC features a limited size range toward larger species (depending on the column). Therefore, it is challenging to develop a specific method for AAV detection. Nonetheless, our large knowledge base allows us to offer cutting edge analytical method development. Please follow the link for more information.
Asymmetrical flow field-flow fractonation (AF4), coupled with a multi-angle 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.
AUC is a first principle method. Therefore, the separation mechanism is well understood and extensively described. Please follow the link to a detailed description of AUC theory.
Even though SV-AUC is with its more than 100 years of history a by far older technique than most others currently used within biopharmaceutical development. It is one of the most complex in regards of data evaluation. We have setup our own supercomputer cluster to be able to offer you several different data evaluation approaches, without the need of your data leaving our premises. We currently offer Sedfit and Ultrascan data evaluations. However, if we see the need to use a different software for your very molecule we have the knowledge base to do so. Please follow the link for more information.
The detection of soluble aggregates is a crucial step for a wide range of bio-pharmaceutical products. It can be seen as one of the most important quality parameter, independent of the type of material you want us to analyze for you. if you have a gene therapy, a proteinaceous or an oligonucleotide based product. We can offer a We are offering a wide range of analytical techniques for the determination of soluble aggregates. We can support you with finding the best technique to determine the amount of soluble aggregates as well as their characterization. We also have a specialized web page on this very topic. Please follow the link for more information.
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.
| Main output | Sedimentation coefficient distribution (s, relative concentrations); molecular weight (Mw) |
| Size range | 0.5 – 200 nm; 0.5 kDa to n.a.* |
| Additional outputs | shape information (frictional ratio f/f0); Interaction parameter (B22, ks) |
| Sample volume | 400 µL |
| Measurement type | 12 mm AUC measurement cells with Sapphire windows |
| Temperature range | 4 °C to 40 °C |
* The maximum size is restricted by the particle size
Zentriforce Pharma Research GmbH 2019 – all rights reserved