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SEC-MALLS Services for AAV Development

Related topics:

Size exclusion chromatography (SEC) is the most common technique for aggregate determination. Key advantages are easy handling and good reproducibility. We offer services that include method development of SEC/SEC-MALS methods and the inclusion of multiangle light scattering detection (MALS) to already existing SEC methods. Please follow the link for more information. 

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.

Light scattering is a well defined effect. The physical properties of light scattering are used for several applications, such as dynamic and static light scattering. Please follow the link to a detailed description of light scattering theory. 

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. 


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. 

Size Exclusion Chromatography (SEC – MALS) for Adeno-Associated Virus (AAV) Development

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.

We offer services that include method development of SEC / SEC-MALS methods and the inclusion of multiangle light scattering detection (MALS) to already existing SEC methods. Additionally, we offer service measurements and method qualifications according to ICH guidline Q2.

Why you should use a SEC-MALS Instrument for Method Development 

The separation of species in SEC is based on an interaction with a stationary phase that may result in unwanted effects on sample components and elution profiles.  Species are indeed not always separated solely by size. In some cases, a combination of different separation mechanisms may be observed. To avoid misleading results, it is essential to develop a method that is not solely based on the observed elution pattern of the sample, but that also characterizes each observed eluted species individually. This is possible by coupling a multiangle light scattering detector (MALS) with the HPLC instrument. The state-of-the-art MALS detector ( Wyatt DAWN Heleos II ) at ZentriForce Pharma allows us to obtain the molecular weight of all observed species. With this information we can develop a truly feasible SEC method for you. Please follow the link to our light scattering theory page to learn more about light scattering theory, including MALS.

SEC-MALS Instrumentation

Our scientists have worked with a wide range of biopharmaceutical products. Our experience keeps your expenses low. Combining the Agilent 1260 Infinity II HPLC, Wyatt DAWN Heleos II MALS detector and a Wyatt Optilab T-rEX RI detector, we  work with cutting-edge instrumentation that offer highest sensitivity,  precision and reproducibility.     

Size exclusion chromatography (SEC) is the most common technique for aggregate determination.  The huge advantage is the easy handling, the good reproducible. We offer services ranging from method development of SEC/SEC-MALLS methods, the inclusion of multi angle laser light scattering detection (MALLS) to a already existing SEC methods. For more information please follow the link.

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 common technique for aggregate determination.  The huge advantage is the easy handling, the good reproducible. We offer services ranging from method development of SEC/SEC-MALLS methods, the inclusion of multi angle laser light scattering detection (MALLS) to a already existing SEC methods. For more information please follow the link.

Light scattering is a well defined effect. The physical properties of light scattering are used for several applications, such as dynamic and static light scattering. Please follow the link to a detailed description of light scattering theory. 

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. 

Interested in Analytical Services ?

We are more than happy to assist you with our SEC-MALLS services.
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SEC-MALLS Specifications

Main Outputfractiogram (relative concentrations); molecular weight (Mw)
Size range1 kDa to 5 MDa
Aditional Outputs radius of gyration (rg), 
Sample Volumedepending on the column
Measurement typevial based
Temperature range 10°C to 85°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.
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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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