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SV-AUC Services for Peptide Development

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.

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  In addition, our instrument, the DynaPro®Plate Reader III, allows us to apply static light scattering (SLS) to characterize your peptides. For more information about the use of DLS in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The species’ small size results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development please follow the link.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide-based APIs or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development 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 Peptide Development

Peptides are molecules that are at the lower edge of the size range suitable for classical protein analysis techniques, and too large for established methods for small molecule analysis. Their size thus poses a challenge in analytical method development. Considering this, SV-AUC is an excellent choice for purity assessment of peptide products. Advanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. We have set up our own computer cluster at ZentriForce Pharma to offer such services, without the need for costumer data to leave our facility. 

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.  Please follow the link to our SV-AUC theory page for more information.

SV-AUC Services

Our scientists have worked with a wide range of biopharmaceutical products and have developed SV-AUC methods for oligonucleotides down to 1 kDa. We are experienced in supporting peptide production optimization and biosimilarity studies of small peptides (e.g. glatiramer acetate). Specialized equipment is available at our facilities to measure small species under ideal experimental conditions.

We provide methods that deliver highest quality results and maximum throughput of up to 6 samples per run.  Consequently, we guarantee low cost for sample analysis.

Our state-of-the-art equipment, the Optima Analytical Ultracentrifuge, enables us to provide high resolution and high throughput measurements. Additionally, we offer high quality data evaluation approaches, such as Ultrascan. For this purpose, we have set up our own computer cluster. This allows us to carry out all data evaluation at our own facility.

Zentriforce Pharma Quality System

We know that all SV-AUC measurements are relevant for your regulatory submissions or for your production optimization. We have implemented a strict quality system to ensure quality and traceability of all SV-AUC data. We have a wide range of quality related standard operation procedures (SOPs) in place. Our quality manager trains employees on relevant documents and processes and ensures that equipment is maintained and handles by qualified personnel only. Customer samples are handled with utmost care and according to detailed instructions. We invite all (potential) costumers to audit our facility, our quality system and your data. Please follow the 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.

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  DLS provides information about particle occurrence. In addition, our instrument, the DynaPro®Plate Reader III, allows us to measure static light scattering (SLS) to characterize your peptides. For more information about the use of DLS in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The small size of the species results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development please follow the link.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide API or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development 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.
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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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