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Zentriforce Pharma Research GmbH 2024 – all rights reserved
SV-AUC is an important part of a complete biosimilarity study. The regulatory bodies like FDA and EMA a more and more insistent on seeing SV-AUC data for the submission. ZentriForce Pharma is your partner for the development of a robust and specific SV-AUC method. Please follow the link for more information.
SV-AUC is a high-resolution method for the determination of soluble aggregates. It can be seen as the gold standard and can be a helpful tool, especially in cases of troubleshooting. Additionally. it is widely used for the verification of size exclusion chromatography methods. For more information about the use of SV-AUC in biopharmaceutical development please follow the link.
Gene therapy is a comparably new trend in biopharmacuetical development. Therefore, there is not yet a fixed portfolio of standard analytical approaches. However, it is clear that SV-AUC is one of these techniques. It is the only technique to separate species due to their size and density at the same time. Therefore, SV-AUC can be used to measure on of the most crucial quality attributes (the ratio of particles without genetic information) of your gene therapy products. Our scientists have already worked with a wide range of gene therapy products (ranging from small DNA/RNA complexes over adeno-associated viruses and lysosomal formulations up to complete viruses) and are keen to assist you with your very molecule. If you need more information please follow one of the following links.
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.The content of soluble aggregates is one of the most crucial quality attributes of pharmaceutical drug products. Their quantification is necessary for all drug products independent of the type of API. ZentriForce Pharma offers a wide range of analytical techniques for the detection of soluble aggregates. If you need further information please follow the link.
Depending on the size of your API, particle size determination (between 1 nm and 1 μm ) may be one of the most important steps for the monitoring of your drug product’s quality. ZentriForce Pharma offers a wide range of techniques to collect data on quality and stability properties of APIs. For further information please follow the link.
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) is the established gold standard in aggregation analytics. SV-AUC is a first principle method. Measurements can deliver information such as relative concentrations, sedimentation coefficients, molecular weights and shape information (frictional ratio) within a single measurement. While its orthogonal technique SEC might show results that are influenced by interactions between sample and column material, SV-AUC does not rely on a stationary phase and is thus not prone to change the sample composition.
Additionally, sedimentation velocity analytical ultracentrifugation sample is not diluted with mobile phase during measurements. The technique’s advantageous properties are the reason for which regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results. It is advisable to verify SEC results by sedimentation velocity analytical ultracentrifugation.
SV-AUC measurements provide information on sample composition as well as on the nature of the observed species (molecular weight, sedimentation coefficient and shape information). This data not only helps to quantify impurites it also helps to identify the detected impurities.
Follow the link to our AUC theory page to learn more about analytical ultracentrifugation (AUC) theory.
Zentriforce Pharma is a contract research organization that specializes in analytical services with a focus on hydrodynamic methods. Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of sedimentation velocity analytical ultracentrifugation (SV-AUC) methods for a large variety of samples. ZentriForce Pharma offers SV-AUC services under BSL 1 and 2.
Our scientists have worked with a wide range of biopharmaceutical products. The experience we gained in AUC method development enables us to provide methods featuring both, highest quality results and maximum throughput (up to 16 samples per run). Consequently, we can guarantee to keep the cost per sample as low as possible. As we perform all measurements on the new Optima Analytical Ultracentrifuge, we are able to perform high resolution data and high throughput services.
Additionally, we are able to provide advanced quality data evaluation approaches, such as Ultrascan. Our computer cluster allows us to carry out all data evaluation at our own facility.
We provide detailed information for specific sample categories. Please follow the links in the related topics section on the left to find sample specific AUC information.
If your sample type is not mentioned in the topics section, feel free to contact us directly.
SV-AUC is an important part of a complete biosimilarity study. The regulatory bodies like FDA and EMA a more and more insistent on seeing SV-AUC data for the submission. ZentriForce Pharma is your partner for the development of a robust and specific SV-AUC method. Please follow the link for more information.
SV-AUC is a high-resolution method for the determination of soluble aggregates. It can be seen as the gold standard and can be a helpful tool, especially in cases of troubleshooting. Additionally. it is widely used for the verification of size exclusion chromatography methods. For more information about the use of SV-AUC in biopharmaceutical development please follow the link.
Gene therapy is a comparably new trend in biopharmacuetical development. Therefore, there is not yet a fixed portfolio of standard analytical approaches. However, it is clear that SV-AUC is one of these techniques. It is the only technique to separate species due to their size and density at the same time. Therefore, SV-AUC can be used to measure on of the most crucial quality attributes (the ratio of particles without genetic information) of your gene therapy products. Our scientists have already worked with a wide range of gene therapy products (ranging from small DNA/RNA complexes over adeno-associated viruses and lysosomal formulations up to complete viruses) and are keen to assist you with your very molecule. If you need more information please follow one of the following links.
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.The content of soluble aggregates is one of the most crucial quality attributes of pharmaceutical drug products. Their quantification is necessary for all drug products independent of the type of API. ZentriForce Pharma offers a wide range of analytical techniques for the detection of soluble aggregates. If you need further information please follow the link.
Depending on the size of your API, particle size determination (between 1 nm and 1 μm ) may be one of the most important steps for the monitoring of your drug product’s quality. ZentriForce Pharma offers a wide range of techniques to collect data on quality and stability properties of APIs. For further information please follow the link.
| 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 2024 – all rights reserved