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SEC-MALLS Services for Peptide 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. 

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.

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. For more information about the use of DLS in peptide development please follow the link.

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.

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.

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. 

Size Exclusion Chromatography (SEC–MALLS) for Peptide Development

Size exclusion chromatography (SEC) is the standard 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 method development of SEC / SEC-MALLS methods to the inclusion of multiangle laser light scattering detection (MALLS) to already existing SEC methods.

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.

Using a SEC-MALLS Instrument for Method Development 

The separation of species in SEC is based on an interaction with a stationary phase that may result in unwanted effects on sample components and elution profiles.  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. This is possible by coupling a multiangle laser light scattering detector (MALLS) with the HPLC instrument. 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.

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.

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  DLS provides information about particle occurrence. In addition, our instrument, the DynaPro®Plate Reader III, allows us to measure static light scattering (SLS) to characterize your peptides. For more information about the use of DLS in peptide development please follow the link.

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 (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. 

Interested in Analytical Services ?

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