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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.
Size exclusion chromatography (SEC) is the most widely used technique for aggregate determination in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility that this method provides. To avoid misleading results, it is essential to develop a method that is not solely based on the observed elution pattern of the sample, but that also characterizes each observed eluted species individually. The state-of-the-art MALLS detector (Wyatt DAWN Heleos II) at ZentriForce Pharma allows us to obtain the molecular weight of all observed species. With this information we can develop a truly feasible SEC method for you. For more information please follow the link.
Dynamic light scattering is a valuable tool for biopharmaceutical development. It is a fast and efficient screening method for aggregate / particle detection. DLS closes the gap between the range of small soluble aggregates that are detected via size exclusion chromatography (SEC), and particles analyzed by methods such as light obscuration (LO) or micro flow imaging (MFI). Owing to the technique’s high sensitivity towards large species, even small impurities can be detected within the measurement range of0.5 nm to 1 µm. If you want to hear more about the use of DLS in biopharmaceutical development please follow the link.
AF4 is a valuable tool for verification of SEC results. It can use the same mobile phase but does not depend on a stationary phase. AF4 thus is an exceptionally useful technique to investigate the effect of the stationary phase on SEC results. AF4 is applicable to establishing screening methods with large measurement ranges, from 1 nm up to 1 μm. Despite the vast size region, high resolution within the oligomeric range is possible. In combination with a multiangle laser light scattering (MALLS) detector, AF4 allows us to quantify as well as characterize different species, for example in regard to their molecular weight). For further information please follow the link.
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.
Looking back at nearly 100 years of scientific advancements, SV-AUC is still a highly relevant analytical technique. Its value in product development is profound. SV-AUC is a first principle method and gathers information such as relative concentrations, sedimentation coefficients, molecular weights and shape information (frictional ratio) within a single measurement. While established analytical techniques such as SEC might render results that are easily misinterpreted, due to interactions of a sample with the column material, SV-AUC measurements do not require a stationary phase and are not vulnerable to changes in sample behavior. A development study that solely relies on SEC measurements always carries the danger of wrong conclusions being drawn from the collected data and should be backed-up by a first principle method.
Please follow the link to our SV-AUC theory page to learn more about sedimentation velocity analytical ultracentrifugation (SV-AUC) theory.
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is regarded as the gold standard for aggregation analytics. SV-AUC is a first principle method, and in contrast to size exclusion chromatography (SEC), SV-AUC does not rely on a stationary phase. Interactions between sample and stationary phase might have an influence on the measured sample composition. Sample may, for example, specifically absorb species, split oligomers, or form such. Furthermore, SV-AUC samples are not diluted by a mobile phase. For these reasons, regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results. We therefore advise to always verify SEC results by a first principle method like SV-AUC.
SV-AUC measurements provide data on sample composition and collect information on the observed species’ molecular weights and sedimentation coefficients This potentially helps to identify impurities.
Our scientists have worked with a wide range of biopharmaceutical products. Our experience in AUC method development enables us to provide methods that deliver both, highest quality results and maximum throughput of up to 14 samples per run. Consequently, we can assure to keep the cost of sample analysis as low as possible.
State-of-the-art instrumentation enables us to provide high resolution and high throughput at the same time. We carry out all measurements on the new Optima Analytical Ultracentrifuge. Additionally, we offer high quality data assessment approaches, such as Ultrascan data evaluation. Our own computer cluster allows us to carry out all data evaluation at our own facility.
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.
Size exclusion chromatography is the most common technique for aggregate determination. If the method is developed properly SEC can give you reliable and Asymmetrical flow field-flow fractonation is an orthogonal method to size exclusion chromatographie (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC). AF4 can be used for a wide range of applications ranging from the detection of soluble aggregates, characterization of species via multi angle laser light scattering (MALLS) and determination of particle size distributions. For more information please follow the link.
DLS is a highly sensitive method for the detection particles. It is a fast and effective screening method for formulation development and production optimization. If you want to hear more about the use of DLS in biopharmaceutical development please follow the link.
AF4 is a valuable tool to gain additional, essential information about your product. An major advantage of AF4 is the large particle size range that can be covered in a single measurement (1 nm up to 1μm). Therefore, it can be a useful addition within production optimization or trouble shooting. A drawback to the AF4 method in the past used to be a comparably low resolution. This problem was solved by our scientists with the development of the AF4Eval software. For further information please follow the link.
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 2019 – all rights reserved