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DLS Services for Peptide 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.  

Peptides are molecules that are at the lower edge of the size range suitable for classical protein analysis techniques, and too large for established methods for small molecule analysis. Their size thus poses a challenge in analytical method development. Considering this, SV-AUC is an excellent choice for purity assessment of peptide products. Advanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. We have set up our own computer cluster at ZentriForce Pharma to offer such services, without the need for costumer data to leave our facility. Please follow the link for more information.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide-based APIs or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The species’ small size results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development 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 Peptide Development

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  In addition, our instrument, the DynaPro®Plate Reader III, allows us to apply static light scattering (SLS) to characterize your peptides. 

DLS closes the gap between the range of small soluble aggregates that are detected via size exclusion chromatography (SEC), and particles analysed by methods such as light obscuration (LO) or micro flow imaging (MFI). The technique’s high sensitivity towards large species allows detection of even small impurities within the measurement range of 0.5 nm to 1 µm.

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. DLS may provide an even larger benefit in case of changes in formulation development. The option to screen a large number of samples within a single measurement, combined with 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 peptide products. We can help you to find the ideal solution for your sample. 

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 multiple sample measurements in a single run. This allows us to assess the particle size distribution of different samples within a single measurement, 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. Please follow the link to our interaction parameter determination page to learn more about the benefits of interaction parameter determination.

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.  Follow the link to our temperature stability testing page to learn more about temperature stability testing.

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.

Peptides are a class of molecules whose size makes analysis challenging. However, SV-AUC is an excellent choice for determination of aggregate levels of peptides. Advanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. Please follow the link for more information.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide API or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The small size of the species results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development 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. 

Accordion Content

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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
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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