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Peptide Development

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Peptides are molecules that are at the lower edge of the size range suitable for classical protein analysis techniques, and too large for established methods for small molecule analysis. Their size thus poses a challenge in analytical method development. Considering this, SV-AUC is an excellent choice for purity assessment of peptide products. Advanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. We have set up our own computer cluster at ZentriForce Pharma to offer such services, without the need for costumer data to leave our facility. Please follow the link for more information.

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  In addition, our instrument, the DynaPro®Plate Reader III, allows us to apply static light scattering (SLS) to characterize your peptides. For more information about the use of DLS in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The species’ small size results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development please follow the link.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide-based APIs or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development 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. 

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. 

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.


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. 

Peptide Development

Peptides comprise a family of molecules that include fragments of proteins, hormones, toxins, antimicrobials, and many more. Their therapeutic value is high, but analytical handling of peptides is challenging, and instrumentation is run at its physical limits.  Expertise and extensive experience in working with small species such as peptide-based APIs is imperative for successful method development. Our scientists have worked with a large number of peptide-drugs. They will be valuable assets where expertise and consultation in analytical method development are concerned.

Dynamic Light Scattering (DLS) Services for Peptide Development

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  In addition, our instrument, the DynaPro®Plate Reader III, allows us to apply static light scattering (SLS) to characterize your peptides. 

For more detailed information please visit our peptide development specific DLS service page. 

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) for Peptide Development

Peptides are molecules that are at the lower edge of the size range suitable for classical protein analysis techniques, and too large for established methods for small molecule analysis. Their size thus poses a challenge in analytical method development. Considering this, SV-AUC is an excellent choice for purity assessment of peptide productsAdvanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. For more detailed information please visit our peptide development specific SV-AUC service page. 

Size Exclusion Chromatography (SEC – MALLS) for Peptide Development

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. Size exclusion chromatography method development for peptide samples is a challenging task. The small size of the species results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cuttingedge analytical method development. For more detailed information please visit our peptide development specific SEC-MALLS service page. 

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

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences include the application of AF4 within the development of a new peptide API or within a biosimilarity study (e.g. glatiramer acetate). Please visit our peptide development specific AF4 service page for more information. 

Peptides are a class of molecules whose size makes analysis challenging. However, SV-AUC is an excellent choice for determination of aggregate levels of peptides. Advanced data evaluation approaches are necessary to achieve a resolution that is adequate for this application. Please follow the link for more information.

Dynamic light scattering is a crucial part of peptide development. It is a fast and efficient screening method for aggregate and particle detection.  DLS provides information about particle occurrence. In addition, our instrument, the DynaPro®Plate Reader III, allows us to measure static light scattering (SLS) to characterize your peptides. For more information about the use of DLS in peptide development please follow the link.

Size exclusion chromatography method development for peptide samples is a challenging task. The small size of the species results in a low resolution. Nonetheless, relying on our experience, state-of-the-art instrumentation and dedicated team, we can offer cutting edge analytical method development. For more information about the use of SEC-MALLS in peptide development please follow the link.

Although we routinely conduct biosimilarity and gene therapy studies, we are experienced in the development of asymmetrical flow field-flow fractionation (AF4) methods for peptide samples as well.  These experiences also include the application of AF4 within the development of a new peptide API or within a biosimilarity study (e.g. glatiramer acetate). For more information about the use of AF4 in peptide development 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. 

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. 

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.

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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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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 (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.
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. 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
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. They will be valuable assets where expertise and consultation in analytical method development are concerned.
Click here for more information
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