SV-AUC Services for Biosimilarity Studies

Related topics:

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.

Asymmetrical flow field-flow fractionation is an orthogonal method to size exclusion chromatography (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC). While the other two techniques are limited to comparably small size ranges, AF4 methods can cover a measurement range from 1 nm up to 1 μm. AF4 can be used with the same mobile phase as SEC but does not depend on a stationary phase. Therefore, it is suitable to back up SEC methods. If you need further information please follow the link

Dynamic light scattering is a crucial part of every biosimilarity study. It is a fast and efficient screening method for aggregate and 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 (0.5 nm – 1 µm). If you need further 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. This is possible by coupling a multiangle laser light scattering detector (MALLS) with the HPLC instrument. With this information we are able to strengthen your claim of biosimiliarity. For more 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. 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.


General topics:

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.

Please follow this link to our contact page

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) for Biosimilarity Studies

Looking back at a history of nearly 100 years in scientific research and development, SV-AUC remains highly relevant as an analytical technique. Within biosimiliarity studies, SV-AUC is commonly applied to characterize the API and quantify aggregates and fragments. SV-AUC is a first principle method and delivers 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 unexpected (and falsely interpreted) results due to interactions of sample and column material, SV-AUC is not prone to change the sample composition. For this reason, regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results.

Please follow the link to our SV-AUC theory page to learn more about sedimentation velocity analytical ultracentrifugation.

SV-AUC for the Verification of SEC Results

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 information on sample composition and on various crucial parameters of the observed species, such as molecular weight, sedimentation coefficient and shape. This potentially helps to identify impurities. 

SV-AUC Services

Our scientists have worked with most commercially available biopharmaceutical products. Our experience allows us to keep your expenses on method development low. Additionally, we provide highest quality results while keeping the throughput high (up to 14 samples per run). This reduces the cost of sample analysis.

Our instrumentation is state-of-the-art and allows for high resolution and high throughput measurements at the same time. We carry out all measurements on the new Optima Analytical Ultracentrifuge and additionally offer high quality data evaluation approaches, such as Ultrascan. Our own computer cluster allows us to perform all data evaluation at our own facility. Data security has highest priority.

Zentriforce Pharma Quality System

We know that all SV-AUC measurements are relevant for your regulatory submissions. Zentriforce Pharma has implemented a strict quality system to assure that the quality and traceability of all SV-AUC data is guaranteed. We apply a wide range of quality related standard operation procedures (SOPs). Our quality manager trains employees on relevant documents and ensures that equipment is maintained and operated by qualified personnel. Customer samples are treated according to detailed instructions and with utmost care. We invite all (potential) costumers to audit our facility, our quality system and the data we collect for you. Please follow this link to 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.

The interest of the regulatory authorities get orthogonal results to verity the SEC results is growing. AF4 and AUC are the most prominent orthogonal methods. Additionally, they are bot first principle methods.  AF4 however is a comparably complex technique. Therefore, it is important to find an experienced partner for the development of robust and specif AF4 methods. Our scientist have already worked with a wide range of commercial antibodies and oligonucleotides. Therefore, ZentriForce Pharma is your partner for the development of a robust and specific AF4 method.   If you need further information please follow the link

Dynamic light scattering is known as a fast and efficient screening method for aggregate / particle detection. Therefore, it is widely used within biosimilarity studies to close the gap between results gained in the range of small soluble aggregates via size exclusion chromatography (SEC) and particle methods such as light obscuration (LO) and micro flow imaging (MFI). Due to the high sensitivity toward large species, even small impurities can be detected within the measurement range (0.5 nm – 1 µm). If you need further information please follow the link

Size exclusion chromatography is the most common technique for aggregate determination. However, most labs only collect concentration signals without characterization of the detected species. With our SEC-MALLS instrument we are not only able to assure that our SEC methods are specific. We also can measure the identity of the detected species to backup your biosimilarity claim.  For more 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. 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.

Interested in AUC Services ?

We are more than happy to assist you with our AUC services.

Sedimentation Velocity Analytical Ultracentrifugation Specifications

Main outputSedimentation coefficient distribution (s, relative concentrations); molecular weight (Mw)
Size range0.5 – 200 nm; 0.5 kDa to n.a.* 
Additional outputsshape information (frictional ratio f/f0); Interaction parameter (B22, ks)
Sample volume400 µL 
Measurement type12 mm AUC measurement cells with Sapphire windows
Temperature range 4 °C to 40 °C

* The maximum size is restricted by the particle size

Previous
Next
Previous
Next

We use cookies and other tracking technologies to improve your browsing experience on our website, to show you personalized content and targeted ads, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close