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Temperature Stability Testing

Related topics:

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. 

ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio. 

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.

µ-DSC is a well-stablished method for thermodynamic analysis of biomolecules, due to combined high data reproducibility and method sensitivity, and the “structural fingerprint” character of thermograms that is unique for each biomolecule. In addition, µ-DSC provides a direct and label-free measurement of thermal stability without the same solvents restrictions that apply to spectroscopic methods. For more information, please follow the link.


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.

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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. 

Temperature Stability Testing 

Temperature stability is a critical parameter in drug product development, especially during formulation development or within biosimilarity studies. The aggregation temperature (Tagg) and melting temperature (Tm) may be determined by application of a heat ramp. Stress studies at isothermal temperatures are applied to monitor time-dependent structural changes.

ZentriForce Pharma Instrumentation 

Zentriforce Pharma uses the DynaPro®Plate Reader III for temperature stability testing. We offer highest quality dynamic light scattering (DLS), as well as static light scattering (SLS) measurements. The combination of both allows us to simultaneously monitor, the formation of large particles as well as changes in the active pharmaceutical ingredient (API), such as dimer formation, and its soluble aggregates.

The DynaPro®Plate Reader III  can perform measurements at small sample volumes (down to 4 µl).  At the same time, the instrument offers highest available sensitivity and allows us to measure at low concentrations.

The use of a well-plate-based approach provides the opportunity to screen a large number of samples in parallel. This reduces the cost per measured sample. Another benefit that comes with this setup is the elimination of contamination risk of the instrument by previously measured samples. Furthermore, comparability of results increases by simultaneous measurement of multiple samples.  We also offer to implement a system suitability check and/or a reference standard into your sample set.

For a more detailed description of dynamic and static light scattering theory please follow the link.

Accessible Parameters

The simultaneous detection of both, SLS and DLS signals, allows us to screen the melting (Tm), aggregation (Tagg) and onset temperatures (Tonset) at the same time. This information can help to understand both the temperature dependence of the colloidal and conformational stability at the same time. 

Additionally, we offer to set up isothermal stress studies with a high number of samples simultaneously. We are thus able to assess the temperature stability of different samples, e.g. within a formulation development. 

Zentriforce Pharma Temperature Stability Testing Services

Our scientists have worked on a wide range of biopharmaceutical products and offer an expertise that helps keep the expenses of method development as low as possible for you. We provide highest quality results and keep the throughput high as well. We can therefore assure to keep the cost per sample measurement low.

Interested in DLS Services ?

We are more than happy to assist you with our DLS services.
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Temperature Stability Testing Specifications

Main OutputTemperature stability (Tonset, Tm, Tagg)
Size range0.5 – 1000 nm; 1 kDa to 1 Mda
Aditional Outputstime/temperature dependent Size distribution (rH or dH); molecular weight (Mw)
Sample Volume4 µL to 150 µL
Measurement typewell plate (96, 384 or 1536)
Temperature range 4°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.
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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.
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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
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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.
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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 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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