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Viruses

Related topics:

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. For further information please follow the link. 

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. 

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.

Depending on the size of your API, particle size determination (between 1 nm and 1 μm ) may be one of the most important steps for the monitoring of your drug product’s quality. ZentriForce Pharma offers a wide range of techniques to collect data on quality and stability properties of APIs. For further information please follow the link. 

Adeno-associated viruses (AAV) based APIs are currently one of the major focuses in gene therapy.  Up to now they are not know to cause any diseases by themselves and they only cause mild immune responses. As they are part of the dependoparvovirus they cannot replicate without confection with a helper virus. These very facts makes them easy to handle and comparably safe in use. Additionally, the small size (22 nm) of AAV allow an comparably easy analysis in comparison to much larger virus based APIs. For more information about analytical strategies for AAV products please follow the link.

In this subsection we address all gene therapy products that are not viruses or AAVs. Our scientists have worked with a wide range of different gene therapy products, ranging from small DNA / RNA complexes over lyposome-based carrier systems to viruses that are several hundred nanometers in size.  The topic of gene therapy shows such a diversity of approaches that we are not able to cover all current and future development categories. Therefore, in this chapter we try to provide information that is valid for most of them. For more information about analytical strategies for gene therapy products please follow the link.


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.

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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. 

Virus Development

This subsection covers all non-AAV virus-based APIs. As most of them are much larger than AAVs (up to several hundred nanometers), different analytical approaches must be applied. The analytical strategy is strongly dependent on the properties of the respective virus that is used in your product.

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) for Virus Development

Owing to their considerable size, intact viruses pose a challenge in analytics. However, our scientists have tackled this problem before and use their experience to provide you with a custom-tailored method that is applicable to your complex samples.  In addition to particle size distributions that give information on purity, SV-AUC can provide data on the nature of the observed species, including molecular weight, UV signal ratio 260 nm/ 280 nm, sedimentation coefficient and shape information. Its versatility makes SV-AUC one of the most powerful stability and quality indicating techniques in the field of gene therapy. For more information please visit our virus specific AUC service page.

Dynamic Light Scattering (DLS) Services for Virus Development

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 nm – 1 μm). Dynamic light scattering is used to collect particle size distributions. The technique is robust, fast screening of large numbers of samples is possible.  Please visit our virus specific DLS service page for more information.

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

Asymmetrical flow field-flow fractionation (AF4), coupled with a multi-angle 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 within several cases of gene therapy product development. The size range of virus based (ca. 20 – 500 nm) APIs are challenging for traditional techniques. Even the smallest virus-based (ca. 20 nm) APIs are a hurdle 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 must be established. Please visit our virus specific AF4 service page for more information. 

Asymmetrical flow field-flow fractonation (AF4), coupled with a multi-angle 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 within several cases of gene therapy product development. For further information please follow the link. 

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. 

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.

Depending on the size of your API, particle size determination (between 1 nm and 1 μm ) may be one of the most important steps for the monitoring of your drug product’s quality. ZentriForce Pharma offers a wide range of techniques to collect data on quality and stability properties of APIs. For further information please follow the link. 

Adeno-associated viruses (AAV) based APIs are currently one of the major focuses in gene therapy.  Up to now they are not know to cause any diseases by themselves and they only cause mild immune responses. As they are part of the dependoparvovirus they cannot replicate without confection with a helper virus. These very facts makes them easy to handle and comparably safe in use. Additionally, the small size (22 nm) of AAV allow an comparably easy analysis in comparison to much larger virus based APIs. For more information about analytical strategies for AAV products please follow the link.

In this subsection we address all gene therapy products that are not viruses or AAVs. Our scientists have worked with a wide range of different gene therapy products, ranging from small DNA / RNA complexes over lyposome-based carrier systems to viruses that are several hundred nanometers in size.  The topic of gene therapy shows such a diversity of approaches that we are not able to cover all current and future development categories. Therefore, in this chapter we try to provide information that is valid for most of them. For more information about analytical strategies for gene therapy products please follow the link.

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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.
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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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