Contact Us
Search
Close this search box.

Aggregate Detection

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). AF4 is applicable to a wide spectrum of uses, including the detection of soluble aggregates, characterization of species via multiangle laser light scattering (MALLS) and determination of particle size distributions. Follow the link for more information.

Size exclusion chromatography (SEC) is the most common technique for aggregate determination. Key advantages are easy handling and good reproducibility. We offer services that include method development of SEC/SEC-MALS methods and the inclusion of multiangle light scattering detection (MALS) to already existing SEC methods. Please follow the link for more information. 

Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support  (between 1 nm and 1 μm ). If you need further information please follow the link. 

ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio. 

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. 

Aggregate Detection 

ZentriForce Pharma is a contract research organization that specializes in analytical services with a focus on hydrodynamic techniques to assess the quality of (bio)pharmaceutical products and ATMPs. A crucial quality attribute of these products is the amount of soluble aggregates.

We offer a wide range of analytical services to assess aggregate levels for a vast number of APIs.  Our current analytical portfolio for aggregate detection comprises:

 

For support in finding the most suitable analytical technique for your product, feel free to contact us directly.

SV-AUC Services

Sedimentation velocity analytical ultracentrifugation (SV-AUC) is the established gold standard for aggregation analytics. SV-AUC is a first principle method that solely relies on known physical effects. In contrast to size exclusion chromatography (SEC), it does neither rely on a stationary nor on a mobile phase and thus does not struggle with the ensuing problems.  Therefore, regulatory bodies such as the FDA and EMA show increasing interest in SV-AUC results.

In addition to information on sample composition, SV-AUC measurements provide data on molecular weight, sedimentation coefficient and shape. 

The new Optima Analytical Ultracentrifuge allows us to provide both, high resolution and high throughput measurements. In addition, we perform  high quality data evaluation using advanced programs such as Ultrascan .

AF4 Services 

Asymmetrical flow field-flow fractionation is an orthogonal method to size exclusion chromatography (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC).  AF4 is a first principle method and therefore solely based on known physical effects. In contrast to size exclusion chromatography (SEC), it does not rely on a stationary phase.  AF4 features an extraordinary accessible size range. Within a single measurement the detection of multiple species, ranging from 1 nm up to 1 μm, is possible. Our AF4 instrumentation consists of UV detection (up to two wavelengths simultaneously), multi-angle laser light scattering (MALS) detection and RI detection. This setup enables us to provide molecular weight and concentration data for non-absorbing species (e.g. liposomal formulations).

SEC MALS Services

Size exclusion chromatography (SEC) is the most established technique for aggregate determination.  It provides easy handling, good reproducibility and high robustness.  The separation in SEC is based on the interaction of different species with a stationary phase. However, separation of different species is not always solely due to size. In some cases, a mixture of different separation mechanisms can be observed, leading to elution profiles that may easily be misinterpreted. It is therefore essential to develop a method that is not restricted to an observed elution pattern. Each eluted species should be properly characterized individually. We recommend coupling an HPLC instrument with a multi-angle light scattering detector (MALS) for SEC method development.  Our state-of-the art MALS detector (Wyatt DAWN®) allows us to obtain molecular weight data on all observed species. With this information your SEC method will be reliable.

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.

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.

Size exclusion chromatography (SEC) is the most common technique for aggregate determination.  The huge advantage is the easy handling, the good reproducible. We offer services ranging from method development of SEC/SEC-MALLS methods, the inclusion of multi angle laser light scattering detection (MALLS) to a already existing SEC methods. For more information please follow the link.

Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support  (between 1 nm and 1 μm ). If you need further information please follow the link. 

ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio. 

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 happy to assist you with our AUC services.
Contact Us
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
Previous slide
Next slide
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
Previous slide
Next slide

Zentriforce Pharma Research GmbH 2024 – all rights reserved