Contact Us
Search
Close this search box.

Other Gene Therapy APIs

Related topics:

Sedimentation velocity analytical ultracentrifugation (SV-AUC) has the potential to become one of the most crucial techniques for evaluation of gene therapy 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. For more information about SV-AUC services in gene therapy development please follow the link.

Gene therapy is a comparatively new trend in biopharmaceutical development. A fixed portfolio of standard analytical approaches has not yet been established. However, it seems obvious that DLS will be among the techniques that are applied for the characterization of gene therapy products. DLS is a fast and sensitive method for sizing species in the sub-micron region.  Our scientists have worked with a wide range of gene therapy products, ranging from small DNA/RNA complexes over adeno-associated viruses and lysosomal formulations up to complete viruses, and are keen to assist you with your specific molecule of interest. For more information about the use of DLS in gene therapy development please follow the link.

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 gene therapy product purity. It is already one of the main assays within several cases of gene therapy product development. Our scientists have already worked with a wide range of gene therapy products, ranging from DNA/RNA complexes over liposomal formulations to complete viruses. This knowledge base helps us to provide you with a tailor designed method for even the most complex samples. Please follow the link for more information about gene therapy related AF4 services.  

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.

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.


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. 

Development of Other Gene Therapy Products

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.

Asymmetrical Flow Field-Flow Fractonation (AF4) Services for other Gene Therapy Products

AF4 is valuable tool for the determination of gene therapy products. The main advantage is the large measurement range (1 nm up to 1 μm) combined with the ability to collect the MALLS signal for molecular weight determination and the simultaneous collection of two UV signals (260 nm + 280 nm).  The combination of the MALLS signal and two UV wavelengths may be used to further characterize the observed species. Information on content of intact API, fragments and aggregates is gathered within a single run. For detailed information please visit our gene therapy specific AF4 service page.

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) of Other Gene Therapy Products 

SV-AUC may potentially develop into a crucial technique in the evaluation of gene therapy product quality. In addition to particle size distribution, SV-AUC delivers data on the purity of your product. SV-AUC measurements can provide information on molecular weight, UV signal ratio at 260 nm/ 280 nm, sedimentation coefficient and shape. This versatility makes SV-AUC one of the most powerful stability and quality indicating techniques in the field of gene therapy. For detailed information please visit our gene therapy specific AUC service page.

Dynamic Light Scattering (DLS) Services for the Development of other Gene Therapy Products

Gene therapy is a comparatively new trend in biopharmaceutical development. A fixed portfolio of standard analytical approaches has not yet been established. However, it seems obvious that DLS will be among the techniques that are applied for the characterization of gene therapy products. DLS is a fast and sensitive method for sizing species in the sub-micron region.  Our scientists have worked with a wide range of gene therapy products, ranging from small DNA/RNA complexes over adeno-associated viruses and lysosomal formulations up to complete viruses and are keen to assist you with your specific molecule of interest. For detailed information please visit our gene therapy specific DLS service page.

SV-AUC may potentially develop into a crucial technique in the evaluation of gene therapy product quality. In addition to particle size distribution delivers data on the purity of your product SV-AUC measurements can provide information on molecular weight, UV signal ratio 260 nm/ 280 nm, sedimentation coefficient and shape. This versatility makes SV-AUC one of the most powerful stability and quality indicating techniques in the field of gene therapy. For more information about SV-AUC services in gene therapy development please follow the link.

Gene therapy is a comparatively new trend in biopharmaceutical development. A fixed portfolio of standard analytical approaches has not yet been established. However, it seems obvious that DLS will be among the techniques that are applied for the characterization of gene therapy products. DLS is a fast and sensitive method for sizing species in the sub-micron region.  Our scientists have worked with a wide range of gene therapy products, ranging from small DNA/RNA complexes over adeno-associated viruses and lysosomal formulations up to complete viruses) and are keen to assist you with your specific molecule of interest. For more information about the use of DLS in gene therapy development please follow the link.

Our scientists have already worked with a wide range of gene therapy products ranging from DNA/RNA complexes over liposomal formulations up to complete viruses. This knowledge base helps us to provide you with a tailor designed method even for the most complex samples. Please follow the link for more information about gene therapy related AF4 services.  

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.

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.

Interested in Analytical Services ?

We are more than happy to assist you with your biosimilarity study.
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 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 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 Pharma Research GmbH 2019 – all rights reserved