SEC-MALLS Services for Biopharmaceutical Development

Related topics:

Size exclusion chromatography (SEC) is the most common technique for aggregate determination. Key advantages are easy handling and good reproducibility. We offer services that include method development of SEC/SEC-MALLS methods and the inclusion of multiangle laser light scattering detection (MALLS) to already existing SEC methods. 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.

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 of0.5 nm to 1 µm. If you want to hear more about the use of DLS 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

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. 


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. 

Size Exclusion Chromatography (SEC – MALLS)  for Biopharmaceutical Development

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. We offer services that range from development of SEC / SEC-MALLS methods to the inclusion of multiangle laser light scattering detection (MALLS) to already existing SEC methods. Additionally, we offer service measurements and method qualifications according to ICH guideline Q2.

Why you should use a SEC-MALLS instrument for Method Development 

We recommend the use of an HPLC instrument coupled with a multiangle laser light scattering detector (MALLS) for SEC method development.  The separation of species in SEC is based on an interaction with a stationary phase. This interaction may cause significant problems, because as a result, species are indeed not always separated solely by size. In some cases, a combination of different separation mechanisms may be observed. 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. Please follow the link to our light scattering theory page to learn more about light scattering theory, including MALLS. 

SEC-MALLS Instrumentation

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 MALLS detector and a Wyatt Optilab T-rEX RI detector, we  work with cutting edge instrumentation that offer highest sensitivity,  precision and reproducibility.     

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.

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.

DLS is a highly sensitive method for the detection particles. It is a fast and effective screening method for formulation development and production optimization. If you want to hear more about the use of DLS 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 (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.

Accordion Content

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. 

Interested in Analytical Services ?

We are more than happy to assist you with our SEC-MALLS services.

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
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