Biopharmaceutical Development

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. 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. For more information please follow the link.

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

Within this section we focus on protein / peptide-based products. Protein (especially antibody) based products are the largest group of biopharmaceutical products.  Despite increased interest in gene therapy products, antibody-based products will dominate the pharmaceutical industry for a long time. For detailed information please follow the link

Within biosimilarity studies it is on the collection of evidence that proves 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 difference in focus between development and biosimilarity testing requires a different mindset and a different study design for the respective task. ZentriForce Pharma can be a valuable partner on your way to release a biosimilar. For further information, please proceed to our biosimilarity page.

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.  For further information please proceed to our peptide page.


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. 

Biopharmaceutical development

The development of biopharmaceutical products is a challenging and costly process. Our scientists have supported numerous development studies and can be valuable assets where expertise and consultation in analytical method development are concerned. For biopharmaceutical development we mostly support production optimization and the development of analytical methods, and we assist in formulation development.

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) Services for Biopharmaceutical Development

Looking back at nearly 100 years of scientific advancements, SV-AUC is still a highly relevant analytical technique. Its value in product development is profound. Being a first principle method, SV-AUC gathers information such as relative concentrations, sedimentation coefficients, molecular weights and shape information (frictional ratio) within a single measurement.  While established analytical techniques such as SEC might render results that are easily misinterpreted, due to interactions of a sample with the column material, SV-AUC measurements are not vulnerable to changes in sample behavior. A development study that solely relies on SEC measurements always carries the danger of wrong conclusions being drawn from the collected data. For more information please visit our biopharmaceutical development specific SV-AUC service page.

Dynamic Light Scattering (DLS) Services for Biopharmaceutical Development

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 of 0.5 nm to 1 µm. For more information visit our biopharmaceutical development specific DLS service page.

Size Exclusion Chromatography (SEC) Services 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. 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. We recommend the use of an HPLC instrument coupled with a multiangle laser light scattering detector (MALLS) for SEC method development.  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. For more information visit our biopharmaceutical development specific SEC-MALLS service page.

Asymmetrical Flow Field-Flow Fractionation (AF4) Services for Biopharmaceutical Development

We routinely conduct biosimilarity and gene therapy studies and are furthermore experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for a large variety of samples.  This includes the application of AF4 within the development of new biopharmaceutical APIs. 

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 more information visit our biopharmaceutical development specific AF4 service page.

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.

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

Within this section we focus on protein / peptide-based products. Protein (especially antibody) based products are the largest group of biopharmaceutical products.  Despite increased interest in gene therapy products, antibody-based products will dominate the pharmaceutical industry for a long time. For detailed information please follow the link

Within biosimilarity studies it is on the collection of evidence that proves 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 difference in focus between development and biosimilarity testing requires a different mindset and a different study design for the respective task. ZentriForce Pharma can be a valuable partner on your way to release a biosimilar. For further information, please proceed to our biosimilarity page.

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.  For further information please proceed to our peptide page.

Interested in Analytical Services ?

We are more than happy to assist you with your biosimilarity study.
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