DLS Services for Biopharmaceutical Development

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) is regarded as the gold standard for aggregation analytics. SV-AUC is a first principle method, and in contrast to size exclusion chromatography (SEC), SV-AUC does not rely on a stationary phase.  Furthermore, SV-AUC samples are not diluted by a mobile phase. For these reasons, regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results. We therefore advise to always verify SEC results by a first principle method like SV-AUC. For more information about the use of SV-AUC in biopharmaceutical development please follow the link.

AF4 is a valuable tool for verification of SEC results. It can use the same mobile phase but does not depend on a stationary phase. AF4 thus is an exceptionally useful technique to investigate the effect of the stationary phase on SEC results. AF4 is applicable to establishing screening methods with large measurement ranges, from 1 nm up to 1 μm. Despite the vast size region, high resolution within the oligomeric range is possible. In combination with a multiangle laser light scattering (MALLS) detector, AF4 allows us to quantify as well as characterize different species, for example in regard to their molecular weight). For further information please follow the link

Size exclusion chromatography (SEC) is the most widely used technique for aggregate determination in biopharmaceutical development. Obvious advantages are the easy handling and the good reproducibility that this method provides. 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. The state-of-the-art MALLS 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. For more information please follow the link.

Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support  (between 1 nm and 1 μm ). If you need further information please follow the link

Temperature stability testing is a crucial step in both biosimiliarity studies and formulation development. It is also a valuable tool in production optimization. With our setups we can support you either investigating the aggregation temperature or doing isotherm stability testings. If you need further information please follow the link

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.

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. 

Dynamic Light Scattering (DLS) Services for Biopharmaceutical Development

Dynamic light scattering is a valuable tool for biopharmaceutical development. It is a fast and efficient screening method for aggregate / particle detection. DLS closes the gap between the range of small soluble aggregates that are detected via size exclusion chromatography (SEC), and particles analyzed by methods such as light obscuration (LO) or micro flow imaging (MFI). Owing to the technique’s high sensitivity towards large species, even small impurities can be detected within the measurement range of 0.5 nm to 1 µm.

DLS is of great value for formulation development, as it allows to screen a large number of samples within a single measurement. Importantly, the simultaneous collection of SLS and DLS data is a most valuable asset. 

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 biopharmaceutical products and taken part in numerous biosimilarity studies. 

With the DynaPro®Plate Reader III ZentriForce Pharma  offers highest quality DLS measurements. The instrument performs dynamic light scattering (DLS) as well as static light scattering (SLS) measurements. Its 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 measure multiple samples sin a single run. This allows us to assess the particle size distribution of different samples within a single measurement (e.g. within a formulation development). 

DLS related Services

Simultaneous DLS and SLS (static light scattering) measurements allow 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.  For further information follow this link.

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

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 is a high-resolution method for the determination of soluble aggregates. It can be seen as the gold standard and can be a helpful tool, especially in cases of troubleshooting. Additionally. it is widely used for the verification of size exclusion chromatography methods.  For more information about the use of SV-AUC in biopharmaceutical development please follow the link.

AF4 is a valuable tool to gain additional, essential information about your product. An major advantage of AF4 is the large particle size range that can be covered in a single measurement (1 nm up to 1μm). Therefore, it can be a useful addition within production optimization or trouble shooting.  A drawback to the AF4 method in the past used to be a comparably low resolution. This problem  was solved by our scientists with the development of the AF4Eval software. For further information please follow the link

Size exclusion chromatography is the most common technique for aggregate determination. If the method is developed properly SEC can give you reliable and   Asymmetrical flow field-flow fractonation is an orthogonal method to size exclusion chromatographie (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC). AF4 can be used for a wide range of applications ranging from the detection of soluble aggregates, characterization of species via multi angle laser light scattering (MALLS) and determination of particle size distributions. For more information please follow the link.

Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support  (between 1 nm and 1 μm ). If you need further information please follow the link

Temperature stability testing is a crucial step in both biosimiliarity studies and formulation development. It is also a valuable tool in production optimization. With our setups we can support you either investigating the aggregation temperature or doing isotherm stability testings. If you need further information please follow the link

Interested in DLS Services ?

We are more than happy to assist you developing your biosimiliar.

DLS Specifications

Main OutputSize distribution (rH or dH); molecular weight (Mw)
Size range0.5 – 1000 nm; 1 kDa to 1 Mda
Aditional OutputsTemperature stability (Tonset, Tm, Tagg); Interaction parameter (A22, kD)
Sample Volume4 µL to 150 µL
Measurement typewell plate (96, 384 or 1536)
Temperature range 4°C to 85°C
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