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Zentriforce Pharma Research GmbH 2019 – all rights reserved
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is the gold standard in aggregation analytics. The importance of SV-AUC results is growing, especially in biosimilarity studies, and also within the development of gene therapy products. ZentriForce Pharma offers SV-AUC services for a wide sample spectrum. 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). AF4 is applicable to a wide spectrum of uses, including the detection of soluble aggregates, characterization of species via multiangle laser light scattering (MALLS) and determination of particle size distributions. Follow the link for more information.
Dynamic light scattering is known as a fast and efficient screening method for aggregate / particle detection. It is widely used within biopharmaceutical development. DLS closes the gap between techniques like size exclusion chromatography (SEC), that measure small soluble aggregates and particle methods such as light obscuration (LO) or micro flow imaging (MFI). Due to a high sensitivity toward large species, even small impurities can be detected within the measurement range (0.5 nm – 1 µm). Please follow the link for more information.
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.
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.
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.
ZentriForce Pharma is a contract research organization that specializes in analytical services with focus on hydrodynamic techniques. We assess crucial quality parameters for API products. Currently, our service portfolio comprises the following analytical techniques:
If you are looking for support in finding the most suitable analytical technique for analysis of your API, feel free to contact us directly.
ZentriForce Pharma offers all services and analytical techniques for S1 and S2 samples.
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is the established gold standard in aggregation analytics. SV-AUC is a first principle method. SV-AUC measurements can deliver 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 results that are influenced by interactions between sample and column material, SV-AUC does not rely on a stationary phase and is thus not prone to change the sample composition. Additionally, SV-AUC sample is not diluted with mobile phase during measurements. The technique’s advantageous properties are the reason for which regulatory bodies like FDA and EMA show steadily increasing interest in SV-AUC results. It is advisable to always verify SEC results by SV-AUC.
SV-AUC measurements provide information on sample composition as well as on the nature of the observed species (molecular weight, sedimentation coefficient and shape information). This data potentially helps to identify impurities.
Our state-of-the-art instrumentation, the new Optima Analytical Ultracentrifuge, provides high resolution as well as high throughput measurements. Our services include advanced quality data evaluation with analytical software approaches such as Ultrascan . Please visit our SV-AUC service page for more information.
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 features an extraordinarily broad accessible size range. Within a single measurement detection of multiple species ranging from 1 nm up to 1 μm is feasible. It does not rely on a stationary phase, which reduces the risk of unexpected changes in sample composition. For more information please visit our AF4 Service page.
Dynamic light scattering is established as a fast and efficient screening method for aggregate / particle detection and finds extensive application within biopharmaceutical development. DLS closes the gap between data from small soluble aggregates that is collected via size exclusion chromatography (SEC), and data from particle methods such as light obscuration (LO) or micro flow imaging (MFI). Owing to the technique’s high sensitivity toward large species, DLS detects even small impurities within the measurement range of 0.5 nm – 1 µm.
With the DynaPro®Plate Reader III, ZentriForce Pharma offers highest quality DLS measurements. The instrument performs dynamic light scattering (DLS) as well as static light scattering (SLS) measurements. Its properties allow for drastic reduction of sample volume, with a minimum of 4 µL, without the need to introduce an oil film to cover the sample. Additionally, sample measurement at low concentrations is feasible, owing to the instrument’s high sensitivity.
The instrument’s well-plate system allows high throughput campaigns. We offer to measure multiple samples sin a single run. This allows us to assess the particle size distribution of different samples within a single measurement.
For aggregation and stability testing we offer temperature-controlled measurements. Temperature ramps access the aggregation temperature, while stability is monitored at a constant elevated temperature. Details can be found on our temperature stability testing page
Please visit our DLS service page for more information.
Size exclusion chromatography (SEC) is the standard 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-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.
Separation in SEC is based on an interaction with a stationary phase. This interaction may cause grave problems as species are not always separated solely by size. In some cases, a mixture 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 to also individually characterize each eluted species. We recommend to use 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. With this information we are able to develop a truly feasible SEC method for you. For more information please visit our SEC-MALLS service page.
Sedimentation velocity analytical ultracentrifugation (SV-AUC) is seen as the gold standard for aggregation analytics. The importance of SV-AUC results is growing especially in biosimilarity studies as well as the development of gene therapy products. ZentriForce Pharma offers SV-AUC services for a wide range of samples. For more information please follow the link.
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.
| Technique | AUC | AF4 | DLS | SEC-MALLS |
| Main Output | s, M, conc | rH, M, conc | rH, M | M, conc |
| Additional Outputs | ks, B22 | kD | Tagg, A22, kD | |
| Size Range (Kda) | 0,5 – n.a.* | 0,5 – n.a.* | 1,0 – 1000** | 1,0 – 5000 |
| Size Range (nm) | 0,5 – 200 | 1,0 – 1000 | 0,5 – 1000 | 0,5 – 20 |
| Sample Volume (µl) | 400 (at ca. 0.5 mg/ml) | 2 -100 | 4 – 150 | 2 -100 |
| Temperautre range (°C) | 4 – 40 | 10 – 85 | 4 – 85 | 10 – 85 |
* The maximum size is restricted by particle size; ** The restriction is only for the determination of the molecular weight via SLS. The sizing via DLS is only restricted by particle size.
Zentriforce Pharma Research GmbH 2019 – all rights reserved