Antibodies, or Immunoglobulins, are key proteins in the immune system. Apart from this they are widely used as biopharmaceuticals and research tools. The test case shows the SAXS reconstruction of the low-resolution envelope structure of IgG1 in native conditions.
Here we show the case of SAXS time-resolved reconstruction of a peptide- HIV fusion inhibitor in native environments(serum/plasma).
Protein aggregation is a common biological phenomenon. With the use of SAXS we studied alpha-synuclein aggregation - a process of assembly of monomers into oligomers and beta-sheets followed by Lewy-body formation. The process is seen as a pathway for Parkinson's disease.
Particle sizing at nanoscale is a classical application for the SAXS methodology. This test case shows the reconstruction of the particle size distribution for ERM FD100 (European Reference Material) - developed and validated with the active participation of DANNALAB.
Lipid mono-layered vesicles are used as drug delivery platforms. Our SAXS methodology allows for the accurate determination of internal structure of micelles.
Liposomes are potent drug carriers, which we can analyse using our SAXS methodology and our dedicated software.
Counterfeit drug production and penetration into supply chain is a matter of concern for both - goverments and pharmaceutical businesses. Together with industrial partner we are developing XRPD methodologies capable to distinguish original and counterfeit medicines, including nondestructive in-blister analysis.
The XRPD methodology is capable of quantifying the amount of crystalline forms within an amorphous API. Here we show the test case of the quantification of crystalline forms in an amorphous API which is within a finished drug product.
Transdermal patches are widely used for the delivery of drug product trough the skin, with dose distributed over time. The low crystallinity of an API is important to ensure timely release of API. The test case shows XRPD characterization of amorphous API over the patch surface and the identification of an area with undesirable API recrystallization.
Different types of blisters may exhibit varying resistance to humidity. This test case shows stability studies of a finished drug product conducted with different types of blisters.
This test case describes examples and possibilities of quantification of polymorph impurities within a finished drug product.
Calcium hydroxyapatite nowadays is widely used as a synthetic bone coating for orthopedic prostheses. The purity of raw material must be controlled according to strict requirements.