Biosimilarity Studies

Related topics:

Within biosimiliarity studies, SV-AUC is commonly applied to characterize the API and quantify aggregates and fragments. SV-AUC is a first principle method and delivers information such as relative concentrations, sedimentation coefficients, molecular weights and shape information (frictional ratio) within a single measurement. While its orthogonal technique SEC might show unexpected (and falsely interpreted) results due to interactions of sample and column material, SV-AUC is not prone to change the sample composition. For this reason, regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results.  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 eluted species individually. This is possible by coupling a multiangle laser light scattering detector (MALLS) with the HPLC instrument. With this information we are able to strengthen your claim of biosimiliarity. For more information please follow the link.

Asymmetrical flow field-flow fractionation is an orthogonal method to size exclusion chromatography (SEC) and sedimentation velocity analytical ultracentrifugation (SV-AUC). While the other two techniques are limited to comparably small size ranges, AF4 methods can cover a measurement range from 1 nm up to 1 μm. AF4 can be used with the same mobile phase as SEC but does not depend on a stationary phase. Therefore, it is suitable to back up SEC methods. If you need further information please follow the link

Dynamic light scattering is a crucial part of every biosimilarity study. It is a fast and efficient screening method for aggregate and 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 (0.5 nm – 1 µm). If you need 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

For biopharmaceutical development we focus on support of production optimization, the development of analytical methods, or assistance in formulation development. For further information please proceed to our biopharmaceutical development 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. 

Biosimilarity studies 

The aim of biosimilarity studies is to provide evidence that no differences larger than method variability exist in the structure and purity of a proposed biosimilar and the reference product. Supporting data is collected through extensive analytical testing that may be performed in R&D laboratories. However, as all results are already relevant for data submission to the authorities, the results must be indubitable and trustworthy. Therefore, it is critical for successful admission of your biosimilar to work with a reliable partner that you (and the FDA and EMA) can trust to deliver high quality services. ZentriForce Pharma has established a laboratory quality system that closely follows extensive and detailed guidelines provided by the WHO and the principle of “writing what you do and doing what you write”. For further information, please follow the link to a description of our ZentriForce quality system.

Our scientists have supported numerous biosimilarity studies and can be valuable assets where expertise and consultation are concerned. We offer a wide range of analytical services that provide valuable data for your studies.

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) for Biosimilarity Studies

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. Interactions between sample and stationary phase might have an influence on the measured sample composition. Sample may, for example, specifically absorb species, split oligomers, or form such.  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.

SV-AUC measurements provide information on sample composition and on various crucial parameters of the observed species, such as molecular weight, sedimentation coefficient and shape. This potentially helps to identify impurities. 

For more information please visit our biosimilarity specific SV-AUC service page.

Dynamic Light Scattering (DLS) Services for Biosimilarity Studies

Dynamic light scattering is a crucial part of every biosimilarity study. It is a fast and efficient screening method for aggregate and 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 (0.5 nm – 1 µm). For more information please visit our biosimilarity specific DLS service page.

Size exclusion chromatography (SEC – MALLS) for Biosimilarity Studies

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. We recommend to couple a HPLC instrument with a multi-angle laser light scattering detector (MALLS) to collect information on each eluted species individually and strengthen your claim of biosimilarity.  For more information please visit our biosimilarity specific SEC-MALLS service page.

Asymmetrical Flow Field-Flow Fractionation (AF4) Services for Biosimilarity Studies 

Authorities show increased interest in orthogonal methods to verify SEC results. Among these, AF4 and AUC are the most prominent. Both are first-principle methods. AF4, however, is a comparably complex technique that requires an experienced scientist for the development of robust and specific AF4 methods. ZentriForce Pharma is a valuable partner for AF4 biosimilarity studies. For more information please visit our biosimilarity specific AF4 service page.

SV-AUC is an important part of a complete biosimilarity study. The regulatory bodies like FDA and EMA a more and more insistent on  seeing SV-AUC data for the submission. ZentriForce Pharma is your partner for the development of a robust and specific SV-AUC method. Please follow the link for more information.

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.

The interest of the regulatory authorities get orthogonal results to verity the SEC results is growing. AF4 and AUC are the most prominent orthogonal methods. Additionally, they are bot first principle methods.  AF4 however is a comparably complex technique. Therefore, it is important to find an experienced partner for the development of robust and specif AF4 methods. Our scientist have already worked with a wide range of commercial antibodies and oligonucleotides. Therefore, ZentriForce Pharma is your partner for the development of a robust and specific AF4 method.   If you need further 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 biosimilarity studies 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) and 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). If you need 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

For biopharmaceutical development we focus on support of production optimization, the development of analytical methods, or assistance in formulation development. For further information please proceed to our biopharmaceutical development 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.
Previous
Next
Previous
Next

We use cookies and other tracking technologies to improve your browsing experience on our website, to show you personalized content and targeted ads, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close