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SV-AUC Services for the Development of other Gene Therapy APIs

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.

Gene therapy is a comparatively new trend in biopharmaceutical development. A fixed portfolio of standard analytical approaches has not yet been established. However, it seems obvious that DLS will be among the techniques that are applied for the characterization of gene therapy products. DLS is a fast and sensitive method for sizing species in the sub-micron region.  Our scientists have 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 specific molecule of interest. For more information about the use of DLS in gene therapy development please follow the link.

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 gene therapy product purity. It is already one of the main assays within several cases of gene therapy product development. Our scientists have already worked with a wide range of gene therapy products, ranging from DNA/RNA complexes over liposomal formulations to complete viruses. This knowledge base helps us to provide you with a tailor designed method for even the most complex samples. Please follow the link for more information about gene therapy related AF4 services.  

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. 

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) of Other Gene Therapy Products

Sedimentation velocity analytical ultracentrifugation (SV-AUC) has the potential to become one of the most crucial techniques for evaluation of gene therapy 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.

SV-AUC Services

Our scientists have worked with a wide range of gene therapy products, ranging from DNA/RNA complexes over liposomal formulations to complete viruses. 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 owed 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. 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.

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.

Gene therapy is a comparatively new trend in biopharmaceutical development. A fixed portfolio of standard analytical approaches has not yet been established. However, it seems obvious that DLS will be among the techniques that are applied for the characterization of gene therapy products. DLS is a fast and sensitive method for sizing species in the sub-micron region.  Our scientists have 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 specific molecule of interest. For more information about the use of DLS in gene therapy development please follow the link.

Our scientists have already worked with a wide range of gene therapy products ranging from DNA/RNA complexes over liposomal formulations up to complete viruses. This knowledge base helps us to provide you with a tailor designed method even for the most complex samples. Please follow the link for more information about gene therapy related AF4 services.  

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. 

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.
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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

ZentriForce Quality System
ZentriForce Pharma has established a laboratory quality system that closely follows the extensive and detailed guidelines provided by the WHO and the principle of “writing what you do and doing what you write”. ZentriForce implements procedural, equipment and analytical SOPs. To date, close to 30 SOPs are in place.
Click here for more information
Gene Therapy
For gene therapy product development, traditional quality attributes as well as new quality attributes must be addressed. Our scientists have worked with a wide range of different gene therapy products, ranging from small DNA / RNA complexes over lyposome-based carrier systems and adeno-associated viruses (AAV) to viruses that are several hundred nanometers in size.
Click here for more information
Biosimilarity
Within biosimilarity studies attention is on the collection of evidence that proves that no differences (larger than method variability) in structure and purity exist between a proposed biosimilar and the reference product. Evidence is collected through extensive analytical testing.
Click here for more information
Peptides
Despite being far less complex than full proteins, analytical handling of peptides is challenging. Species as small as peptide-based APIs require analytical instrumentation to be run at its physical limits. Expertise and extensive experience in working with such materials is imperative for successful method development. Our scientists have worked with a large number of peptide-based APIs, with sizes down to 1 kDa.
Click here for more information
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ZentriForce Quality System
ZentriForce Pharma has established a laboratory quality system that closely follows the extensive and detailed guidelines provided by the WHO and the principle of “writing what you do and doing what you write”. ZentriForce implements procedural, equipment and analytical SOPs. To date, close to 30 SOPs are in place.
Click here for more information
Gene Therapy
For gene therapy product development, traditional quality attributes (e.g. purity) as well as new quality attributes (e.g. the ratio of particles that carry nucleic acids to empty particles) must be addressed. The diversity of approaches for gene therapy API analysis adds a further challenge to product characterization. Our scientists have worked with a wide range of different gene therapy products, ranging from small DNA / RNA complexes over lyposome-based carrier systems and adeno-associated viruses (AAV) to viruses that are several hundred nanometers in size.
Click here for more information
Biosimilarity
Within biosimilarity studies attention is on the collection of evidence that proves that no differences (larger than method variability) in structure and purity exist between a proposed biosimilar and the reference product. Evidence is collected through extensive analytical testing. The different focus between development and biosimilarity testing require an adjusted mindset and a customized study design for the respective task. ZentriForce Pharma can be a valuable partner on your way to release a biosimilar
Click here for more information
Peptides
Despite being far less complex than full proteins, analytical handling of peptides is challenging. Species as small as peptide-based APIs require analytical instrumentation to be run at its physical limits. Expertise and extensive experience in working with such materials is imperative for successful method development. Our scientists have worked with a large number of peptide-based APIs, with sizes down to 1 kDa. They will be valuable assets where expertise and consultation in analytical method development are concerned.
Click here for more information
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