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AF4 Services for Virus Development

Related topics:

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.

Sedimentation velocity analytical ultracentrifugation (SV-AUC) has the potential to become one of the most crucial techniques for quality evaluation of gene therapy products. Owing to their considerable size, intact viruses pose a challenge in analytics. However, our scientists have already tackled this problem before and use their experience to provide you with a custom-tailored method that is applicable to your complex samples. Please follow the link for more information.

Dynamic light scattering is an established analytical technique in the field of gene therapy product development. The size range of virus-based APIs (ca. 20-500 nm) lies well within the detection range of DLS (ca. 0.5- 1 μm). Dynamic light scattering is used to collect particle size distributions. The technique is robust and offers fast screening of large numbers of samples. For further information please follow the link. 

With the increasing interest in gene therapy products also the interested in AF4 is growing. However, AF4 methods are comparably complex to develop. While most people use AF4 only as separation technique. We are experts in AF4 theory and use the theory to get more information out of the technique (e.g. particle size distributions). If you want to get more information about AF4 theory please follow this link.

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. 

Asymmetrical Flow Field-Flow Fractionation (AF4) Services for Virus Development

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 virus product purity. It is already one of the main assays in several cases of gene therapy product development.

Ranging from 20 to 500 nm, the spectrum of virus-based APIs is a challenge for traditional techniques. Even the smallest virus-based APIs are demanding targets for traditional methods such as size exclusion chromatography (SEC). The larger viruses (up to several hundred nm) are impossible to access with traditional techniques. Therefore, new analytical approaches have to be established. Due to the full coverage of the nanometer size range (1 nm up to 1 μm) and the possibility to characterize the observed species by MALLS and multi-wavelength UV spectroscopy, AF4 is one of the most reasonable methods of choice.  

Please follow the link our AF4 theory page for more details.

AF4 for Virus Development

AF4 is a valuable tool for the characterization of virus-based products. One major advantage is the large measurement range of 1 nm to 1 μm. Combined with the ability to collect the MALLS signal that provides data on molecular weight, and the simultaneous collection of two UV signals (260 nm + 280 nm), extensive characterization of the observed species is possible.  Therefore, AF4 is suitable to analyze both, the contents of a sample and the nature of the species within (fragments, the virus and aggregates), in a single run. 

ZentriForce Pharma AF4 Instrumentation

Combining the Agilent 1260 Infinity II HPLC, Wyatt DAWN Heleos II MALLS detector and a Wyatt Optilab T-rEX RI detector, we  work with cutting edge instrumentation that offer highest sensitivity,  precision and reproducibility.     

ZentriForce Pharma Exclusive AF4 Services

Our scientists are experts in the application of AF4 to a wide range of bio-pharmaceutical products; further, we continuously and actively work on the advancement of AF4 and the utilization of its underlying theory. Starting in 2012, we have developed and improved the AF4Eval program. The software enables us to not only use AF4 underlying theory to determine the particle size distribution of a sample, but also to greatly increase the resolution of the technique by application of a diffusion correction algorithm. We hold the exclusive rights to use the software in a commercial environment but are open to provide our customers with licenses if a method transfer to their facility is requested. The software and its performance is described in detail within the following publication. Follow, follow the link for more detailed information.

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.

Owing to their considerable size, intact viruses pose a challenge in analytics. However, our scientists have already tackled this problem before and use their experience to provide you with a tailored method that is applicable to complex samples.  ZentriForce Pharma is your partner for the development of a robust and specific SV-AUC method. Please follow the link for more information.

Dynamic light scattering is an established analytical technique in the field of gene therapy product development. The size range of virus-based APIs (ca. 20-500 nm) lies well within the detection range of DLS (ca. 0.5- 1 μm). Dynamic light scattering is used to collect particle size distributions. The technique is robust and the robustness of the technique and the possibility for a fast screening of large numbers of samples. For further information please follow the link. 

With the increasing interest in gene therapy products also the interested in AF4 is growing. However, AF4 methods are comparably complex to develop. While most people use AF4 only as separation technique. We are experts in AF4 theory and use the theory to get more information out of the technique (e.g. particle size distributions). We even developed our own AF4 data evaluation software. Please follow the link to more information about our AF4Eval software. If you want to get more information about AF4 theory please follow this link.

Our scientists are not only applying AF4 we are also working on the advancement of AF4 and its theory. Since 2012 we are working on the development of the AF4Eval program. Since then it was continuously improved. The software enables us to not only to use AF4 theory to determine the particle size distribution but also to tremendously increase the resolution of the technique by applying a diffusion correction algorithm. 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.

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We are more than happy to assist you with our AF4 services.
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Asymmetrical Flow Field-Flow Fractionation Specificiation

Main OutputSize distribution (rH or dH); relative concentrations; molecular weight (Mw)
Size range1 – 1000 nm
Additional Outputsradius of gyration (rg) 
Sample Volume4 µL to 100 µL
Measurement typeHPLC vial based
Temperature range 18°C to 40°C
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.
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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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