DLS Services for Biosimilarity Studies

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.  

Within biosimiliarity studies, SV-AUC is commonly applied to characterize the API and quantify aggregates and fragments. SV-AUC is a first principle method and delivers information such as relative concentrations, sedimentation coefficients, molecular weights and shape information (frictional ratio) within a single measurement. While its orthogonal technique SEC might show unexpected (and falsely interpreted) results due to interactions of sample and column material, SV-AUC is not prone to change the sample composition. For this reason, regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results.  Please follow the link for more information.

Asymmetrical flow field-flow fractionation is an orthogonal method to size exclusion chromatography (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC). While the other two techniques are limited to comparably small size ranges, AF4 methods can cover a measurement range from 1 nm up to 1 μm. AF4 can be used with the same mobile phase as SEC but does not depend on a stationary phase. Therefore, it is suitable to back up SEC methods. If you need 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. This is possible by coupling a multiangle laser light scattering detector (MALLS) with the HPLC instrument. With this information we are able to strengthen your claim of biosimiliarity. 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

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. 

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 Biosimilarity Studies

Dynamic light scattering is a crucial part of every biosimilarity study. It is a fast and efficient screening method for aggregate and 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 (0.5 nm – 1 µm).

Additionally, the option to perform both, temperature ramps to identify the aggregation temperature, and isothermal measurements (accelerated stability), supports your statement of biosimilarity. 

DLS may be of even larger benefit when a change of the formulation is necessary. The option to screen a large number of samples within a single measurement, including the simultaneous collection of SLS and DLS data, is of immense value in this case.

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

DLS Instrumentation

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. 

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.

Zentriforce Pharma quality system

We know that all DLS measurements are already relevant for your regulatory submissions. ZentriForce Pharma has established a laboratory quality system that closely follows 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. These ensure that equipment is correctly operated and meticulously maintained by qualified personnel only, that customer samples are handled by trained laboratory operators with utmost care and precision, and that confidentiality has highest priority in all aspects of our relationship with our customers We are also more than open to audits of and the results we collected for you. Please find a link to a detailed description of our quality system.

DLS in Biosimilarity Studies

Our scientists have already worked with most commercially available biopharmaceutical products.  For biosimilarity assessments we recommend to start with an in-depth method development. Because of the significance of the results for your regulatory submission we recommend to additionally carry out a method qualification (according to ICH guideline Q2) and develop a method SOP for you before going into routine testing. This way we can evaluate the very quality of the method and give you information about the confidence intervals of the method.

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 an important part of a complete biosimilarity study. The regulatory bodies like FDA and EMA a more and more insistent on  seeing SV-AUC data for the submission. ZentriForce Pharma is your partner for the development of a robust and specific SV-AUC method. Please follow the link for more information.

The interest of the regulatory authorities get orthogonal results to verity the SEC results is growing. AF4 and AUC are the most prominent orthogonal methods. Additionally, they are bot first principle methods.  AF4 however is a comparably complex technique. Therefore, it is important to find an experienced partner for the development of robust and specif AF4 methods. Our scientist have already worked with a wide range of commercial antibodies and oligonucleotides. Therefore, ZentriForce Pharma is your partner for the development of a robust and specific AF4 method.   If you need further information please follow the link

Size exclusion chromatography is the most common technique for aggregate determination. However, most labs only collect concentration signals without characterization of the detected species. With our SEC-MALLS instrument we are not only able to assure that our SEC methods are specific. We also can measure the identity of the detected species to backup your biosimilarity claim.  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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