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DLS Services for the Development of other Gene Therapy APIs

Related topics:

Dynamic light scattering is known as a fast and efficient screening method for aggregate / particle detection. It is widely used within biopharmaceutical development. DLS closes the gap between techniques like size exclusion chromatography (SEC), that measure small soluble aggregates and particle methods such as light obscuration (LO) or micro flow imaging (MFI). Due to a high sensitivity toward large species, even small impurities can be detected within the measurement range (0.5 nm – 1 µm). 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 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.

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.  

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. 

We are offering a wide range of analytical techniques for the determination of particle size distributions.  The detection of nano particle size distributions (1 nm  – 1 μm) is growing in importance. Especially, since the interest in gene therapy increased. Our scientist are working since more than 10 years on the topic of particle size determination. Please follow the link for more information.

In the last couple of years, the interest in the determination of predictive parameters within formulation development has grown. Interactions parameters provide valuable information for the prediction of molecular stability. These values are used in a “design of experiment” (DOE) approach to assist formulation developments. 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.

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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. 

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.

Dynamic light scattering is a fast and efficient screening method for particle size determination. It is widely used within biopharmaceutical development, but its importance is even higher for gene therapy product development. The large measurement range (0.5 nm – 1 µm) makes DLS applicable to most gene therapy products.

Please follow the link to our light scattering theory page to learn more about dynamic and static light scattering theory.

DLS Instrumentation

Our scientists have worked with a wide range of gene therapy products. Our experience in DLS method development keeps your expenses low.

With the DynaPro®Plate Reader III ZentriForce Pharma offers highest quality DLS measurements. The instrument can perform dynamic light scattering (DLS) and static light scattering (SLS) measurements simultaneously, if desired. This allows for particle detection as well as information gathering on parameters such as the molecular weight of your API.

The instrument’s properties allow for drastic reduction of sample volume, with a minimum of 4 µL, without the need to introduce an oil film to cover the sample. Additionally, sample measurement at low concentrations is feasible, owing to the instrument’s high sensitivity. The instrument’s well-plate system allows high throughput campaigns. We offer to set up DLS measurements of multiple samples in a single run. This allows us to assess the particle size distribution of different sample compositions, for example within a formulation development. 

DLS related Services

Simultaneous DLS and SLS (static light scattering) measurements enable us to combine information on particle size distribution and molecular weight. This data provides valuable information on stability. An example for the benefit of this method is the simultaneous determination of the second osmotic virial coefficient (A22) and the concentration dependence of the diffusion coefficient (kD). The combination of these two parameters is especially interesting within formulation development studies. Follow this link for further information.

We additionally offer temperature-controlled measurements with the options to either run temperature ramps to access the aggregation temperature, or to monitor sample stability at a constant temperature. The well-plate-based design of the instrument allows us to measure the samples simultaneously instead of consecutively (as is the case in injection cell based setups). Therefore, we can provide identical measurement conditions for all samples.  Follow this link for further information.

Dynamic light scattering is known as a fast and efficient screening method for aggregate / particle detection. Therefore, it is widely used within biopharmaceutical development. It is used to close the gap between results gained in the range of small soluble aggregates via size exclusion chromatography (SEC) and particle methods such as light obscuration (LO) or micro flow imaging (MFI). Due to the high sensitivity toward large species, even small impurities can be detected within the measurement range (0.5 nm – 1 µm). For more information please follow the link.

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.

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.  

AUC is a first principle method. Therefore, the separation mechanism is well understood and extensively described. Please follow the link to a detailed description of AUC theory. 

We are offering a wide range of analytical techniques for the determination of particle size distributions.  The detection of nano particle size distributions (1 nm  – 1 μm) is growing in importance. Especially, since the interest in gene therapy increased. Our scientist are working since more than 10 years on the topic of particle size determination. Please follow the link for more information.

Interested in DLS Services ?

We are more than happy to assist you with our DLS services.
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Dynamic Light Scattering Specifications

Main outputSize distribution (rH or dH); molecular weight (Mw)
Size range0.5 – 1000 nm; 1 kDa to 1 MDa
Additional outputsTemperature stability (Tonset, Tm, Tagg); Interaction parameter (A22, kD)
Sample volume4 µL to 150 µL
Measurement typewell plate (96, 384 or 1536 wells)
Temperature range 4°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.
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.
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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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