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Zentriforce Pharma Research GmbH 2019 – all rights reserved
The detection of soluble aggregates is a crucial step for a wide range of bio-pharmaceutical products.The content of soluble aggregates is one of the most crucial quality attributes of pharmaceutical drug products. Their quantification is necessary for all drug products independent of the type of API. ZentriForce Pharma offers a wide range of analytical techniques for the detection of soluble aggregates. If you need further information please follow the link.
Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support (between 1 nm and 1 μm ). If you need further information please follow the link.
Temperature stability testing is a crucial step in both biosimiliarity studies and formulation development. It is also a valuable tool in production optimization. With our setups we can support you either investigating the aggregation temperature or doing isotherm stability testings. If you need further information please follow the link.
ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio.
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 offer a wide range of analytical techniques to assess decisive quality parameters for APIs. Here, the focus lies on aggregate analysis and particle size determination.
ZentriForce Pharma offers all services and analytical techniques under BSL 1 and 2.
The detection of soluble aggregates is a crucial step in the development of numerous biopharmaceutical products, as their occurrence is one of the critical quality attributes of pharmaceutical drug products.
Aggregate quantification is necessary for all drug products, independent of the type of API. ZentriForce Pharma offers a range of comprehensive analytical techniques for the detection and quantification of soluble aggregates. We can support you in finding the best technique to characterize your product. Visit our analytical services for soluble aggregates page for more information.
Our services for soluble aggregate analysis include the following techniques:
All techniques have advantages and limitations. We will provide you with the information and advice that you need to find the technique that is the best choice for your product. Feel free to contact us directly if you have any questions on this topic.
Depending on the size of your API, particle size determination might be one of the most important steps to monitor drug product quality. Gene therapy products in particular need monitoring of particle size distribution. We offer extensive analytical techniques suitable for this purpose. Our dedicated scientists provide expertise that stems from more than 10 years of work on the topic of particle size determination. Please follow the link to our particle size determination page for more information.
Our particle size determination services include the following techniques:
Temperature stability testing is a critical step in both, biosimilarity studies and formulation development. Testing temperature stability may also be a beneficial step in production optimization. There are two options to determine temperature stability, one of which is a gradual temperature increase to determine the onset temperature (Tonset), the melting temperature (Tm) or the aggregation temperature (Tagg) of your product. The second option is a stability measurement at a constant temperature that provides information about the long-term stability of different samples or formulations. Please visit our temperature stability testing page for further information.
The detection of soluble aggregates is a crucial step for a wide range of bio-pharmaceutical products.The content of soluble aggregates is one of the most crucial quality attributes of pharmaceutical drug products. Their quantification is necessary for all drug products independent of the type of API. ZentriForce Pharma offers a wide range of analytical techniques for the detection of soluble aggregates. If you need further information please follow the link.
Depending on the size of your API particle size determination (between 1 nm and 1 μm ) can be one of the most important steps for the monitoring of your drug products quality. ZentriForce Pharma offers a wide range of techniques to support (between 1 nm and 1 μm ). If you need further information please follow the link.
Temperature stability testing is a crucial step in both biosimiliarity studies and formulation development. It is also a valuable tool in production optimization. With our setups we can support you either investigating the aggregation temperature or doing isotherm stability testings. If you need further information please follow the link.
ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio.
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.
Zentriforce Pharma Research GmbH 2019 – all rights reserved