Adeno-Associated Virus (AAV) Product Development

Related topics:

Sedimentation velocity analytical ultracentrifugation (SV-AUC) has the potential to become one of the most crucial techniques for evaluation of f adeno-associated virus (AAV) 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. Please follow the link for more information.

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 adeno-associated virus (AAV) product purity. It is already one of the main assays within several cases of gene therapy product development. Please follow the link for more information.

Dynamic light scattering is a well-established analytical technique in the field of AAV development. Its primary use is to test for aggregate formation. Due to its high sensitivity towards large species, even small impurities caused by aggregation can be detected. We apply our dynamic light scattering instrumentation to determine particle size distributions. Additionally, we use this technique to provide information on thermal stability. Please follow the link for more information.

Size exclusion chromatography (SEC) is the most commonly used technique for aggregate determination in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility that this method provides. However, with the recent interest in gene therapy-based APIs the limitations of the technique must be considered. SEC features a limited size range toward larger species, depending on the column, and therefore poses a challenge when a specific method for AAV detection is developed. We are able to tackle that issue, using our experience and state-of-the-art analytical equipment. Please follow the link for more information.

In this sub-section we cover 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. For more information about analytical strategies for virus-based APIs 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 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

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Adeno-Associated Virus (AAV) Product Development

Adeno-associated viruses (AAV) based APIs are a main focus in gene therapy.  They lack pathogenicity themselves and merely cause mild immune responses. As they are part of the dependoparvovirus family they cannot replicate without coinfection alongside a helper virus. AAVs are thus easy to handle and comparably safe in use. Additionally, their small size of 22 nm allows for a comparably easy analysis in comparison to much larger virus-based APIs. We offer four different analytical techniques for the development of AAV specific method developments:

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

Sedimentation velocity AUC (SV-AUC) has the potential to become one of the most crucial techniques for the evaluation of the quality of adeno-associated virus (AAV) products. SV-AUC provides data on the ratio of DNA incorporation into virus capsids. Additionally, this technique gains information about the purity of a product, regarding the amount of 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.

For more information please visit our AAV specific SV-AUC service page.

Asymmetrical Flow Field Flow Fractionation (AF4) for AAV Development

Asymmetrical flow field-flow fractonation (AF4), coupled with a multiangle laser light scattering detector (MALLS), has the potential to develop into a key technique for the evaluation of adeno-associated virus (AAV) product quality. It is already the main assay within several cases of gene therapy product development.

Our AF4-MALLS instrumentation is optimized for the simultaneous collection of multiple UV signals at highest achievable quality. These measurements can quantify the amount of occurring species and provide information about the nature of the observed species, including molecular weight, UV signal ratio at 260 nm/ 280 nm and hydrodynamic radius. An additional, extraordinary feature of AF4 is its accessible size range. In a single measurement, species ranging from 1 nm up to 1 μm are separated and identified. This remarkable attribute makes AF4 especially valuable for the development of gene therapy products, such as AAVs .

For more information please visit our AAV specific AF4 service page.

Dynamic Light Scattering (DLS) Services for AAV Development

Dynamic light scattering is a well-established analytical technique in the field of AAV development. It is primarily used to test for aggregate formation. Due to its high sensitivity towards large species, even small impurities of aggregates can be detected within the measurement range of 0.5 nm to 1 µm.

We apply our dynamic light scattering instrumentation to determine particle size distributions. Additionally, we use this technique to provide information on thermal stability. 

For more information, please go to our AAV specific DLS service page.

Size Exclusion Chromatography (SEC) for AAV Development

Size exclusion chromatography (SEC) is the most commonly used technique for aggregate detection in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility of this method. 

However, with the recent interest in gene therapy-based APIs the limitations of the technique must be considered. SEC features a limited size range toward larger species, depending on the column, and therefore poses a challenge when a specific method for AAV detection is developed. We are able to tackle that issue, using our  experience and state-of-the-art analytical equipment.

For more information, please go to our AAV specific SEC-MALLS service page

Sedimentation velocity AUC (SV-AUC) has the potential to become one of the most crucial techniques for the evaluation of the quality of adeno-associated virus (AAV) products. SV-AUC provides data on the ratio of DNA incorporation into virus capsids. Additionally, this technique gains information about the purity of a product, regarding the amount of 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. Please follow the link 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 adeno-associated virus (AAV) product purity. It is already one of the main assays within several cases of gene therapy product development. Please follow the link for more information.

Dynamic light scattering is a well-established analytical technique in the field of AAV development. It is primarily used to test for aggregate formation. Due to its high sensitivity towards large species, even small impurities of aggregates can be detected within the measurement range of 0.5 nm to 1 µm. Please follow the link for more information.

Size exclusion chromatography (SEC) is the most commonly used technique for aggregate determination in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility that this method provides. However, with the recent interest in gene therapy-based APIs the limitations of the technique have to be considered. SEC features a limited size range toward larger species (depending on the column). Therefore, it is challenging to develop a specific method for AAV detection. Nonetheless, our large knowledge base allows us to offer cutting edge analytical method development. Please follow the link for more information.

In this sub-section we cover 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. For more information about analytical strategies for virus-based APIs 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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