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Gene Therapy

Related topics:

Adeno-associated viruses (AAV) based APIs currently draw attention in gene therapy.  Up to date, they are not known to be pathogenic by themselves and cause mild immune responses. As they are part of the dependoparvovirus family, they depend on a helper virus to replicate. These facts make them easy to handle and comparably safe to use. Additionally, their small size (22 nm) allows for a 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 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 products For more information about analytical strategies for gene therapy products please follow the link.

Within this section we focus on protein / peptide-based products. Protein (especially antibody) based products comprise the largest group of biopharmaceuticals.  Despite increased interest in gene therapy products, antibody-based drugs will dominate the pharmaceutical industry for a long time.  For detailed information 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. 

Gene Therapy

For gene therapy product development, traditional quality attributes like product purity are just as important as, for example, the ratio of carrier particles loaded with nucleic acids to empty particles. Approaches for gene therapy API analysis are therefore diverse and require expertise. Our scientists will help you with the challenging task of product characterization. We have worked with a wide spectrum of different gene therapy products, ranging from small DNA / RNA complexes over liposome-based carrier systems and adeno-associated viruses (AAV) to viruses that are several hundreds of nanometers in size, and we will assist you with your individual product. 

To date, three analytical techniques seem cover analytical requirements for most possible APIs. 

The sub-sections of the Gene Therapy section address:

Adeno-Associated Viruses

Adeno-associated viruses (AAV) based APIs currently draw attention in gene therapy.  Up to date, they are not known to be pathogenic by themselves and cause mild immune responses. As they are part of the dependoparvovirus family, they depend on a helper virus to replicate. These facts make them easy to handle and comparably safe to use. Additionally, their small size (22 nm) allows for a comparably easy analysis in comparison to much larger virus-based APIs.  Please proceed to our AAV page for further information.

Other Viruses

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. Please proceed to our virus page for further information.

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 products.  Please proceed to our other gene therapy products page for further 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 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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