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. 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 can develop a truly feasible SEC method for you. For more information please follow the link.

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.  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. For more information about the use of SV-AUC in biopharmaceutical development please follow the link.

Dynamic light scattering is a valuable tool for biopharmaceutical development. It is a fast and efficient screening method for aggregate / 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 of0.5 nm to 1 µm. If you want to hear more about the use of DLS in biopharmaceutical development please follow the link.

AF4 is a valuable tool for verification of SEC results. It can use the same mobile phase but does not depend on a stationary phase. AF4 thus is an exceptionally useful technique to investigate the effect of the stationary phase on SEC results. AF4 is applicable to establishing screening methods with large measurement ranges, from 1 nm up to 1 μm. Despite the vast size region, high resolution within the oligomeric range is possible. In combination with a multiangle laser light scattering (MALLS) detector, AF4 allows us to quantify as well as characterize different species, for example in regard to their molecular weight). For 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. 

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.

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.