Contact Us
Search
Close this search box.

Size Exclusion Chromatography (SEC-MALLS) Services

Related topics:

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 light scattering detector (MALS) with the HPLC instrument. With this information we are able to strengthen your claim of biosimiliarity. Please follow the link for more information.

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 species individually. 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 for more information. 

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. Please follow the link for more information.

Light scattering is a well-defined interaction effect between light and molecules. The physical properties are useful 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. 

Want to talk to our SEC-MALLS expert?

If you have any question regarding SEC-MALLS Services get in touch with our SEC-MALLS expert Dr. Marius Schmid
Click Here

Size Exclusion Chromatography (SEC – MALS) Services

Zentriforce Pharma is a contract research organization that specializes in analytical services with a focus hydrodynamic methods. Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of size exclusion chromatography (SEC / SEC-MALS) methods for a large variety of samples. ZentriForce Pharma offers SEC-MALS services for BSL 1 and BSL 2 samples.

Size exclusion chromatography (SEC) is the most widely applied technique for aggregate determination. Obvious advantages are the easy handling and the good reproducibility that this method provides. We offer services that range from method development of SEC / SEC-MALS methods to the inclusion of multiangle light scattering detection (MALS) to already existing SEC methods. Additionally, we offer service measurements and method qualifications according to ICH guideline Q2.

Using a SEC-MALS Instrument for SEC Method Development  

We recommend to use an HPLC instrument coupled with a multiangle light scattering detector (MALS) for SEC method development.  The separation in SEC is based on an interaction with a stationary phase. This interaction may cause problems, as species are not always separated solely by size. In some cases, a mixture of different separation mechanisms may be observed. To avoid misinterpretation of elution profiles, it is essential to develop a method that is not solely based on the observed elution pattern of the sample, but to also individually characterize each eluted species.

Size Exclusion Chromatography coupled with Multi Angle Laser Light Scattering Detection (SEC-MALLS) Instrument used at ZentriForce Pharma
Size Exclusion Chromatography coupled with Multi Angle Light Scattering Detection (SEC-MALS) Instrument used at ZentriForce Pharma

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 are able to 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 theory).

SEC-MALS Services

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.     

SEC Sample Specific Services

We provide detailed information for specific sample categories. Please follow the links in the related topics section on the left to find sample specific SEC-MALS information. 

If your sample type is not mentioned in the topics section, feel free to contact us directly. 

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.

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.

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.

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. 

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 (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
Previous slide
Next slide
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
Previous slide
Next slide

Zentriforce Pharma Research GmbH 2024 – all rights reserved