Test Cases of Studies Conducted Using SAXS and XRPD Techniques

SAXS reconstruction of IgG1 Immunoglobulin tertiary envelope structure

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.

SAXS characterizaton of HIV fusion inhibitor in serum and plasma formulations over time

Here we show the case of SAXS time-resolved reconstruction of a peptide- HIV fusion inhibitor in native environments(serum/plasma).

SAXS study of protein aggregation - Alpha-Synuclein

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.

SAXS determination of particle size distribution for the FD100 reference standard material

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.

SAXS characterization of SDS micelle structure in solution

Lipid mono-layered vesicles are used as drug delivery platforms. Our SAXS methodology allows for the accurate determination of internal structure of micelles.

SAXS structural characterization of a liposome-based drug product

Liposomes are potent drug carriers, which we can analyse using our SAXS methodology and our dedicated software.

XRPD for the identification of counterfeit drugs

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.

XRPD quantification of crystalline forms in amorphous API within a formulation

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.

XRPD quality testing of the transdermal patch

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.

XRPD stability study of drug product in different types of blisters

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.

XRPD quantificaton of polymorph impurities in a finished drug product

This test case describes examples and possibilities of quantification of polymorph impurities within a finished drug product.

XRPD control of phase composition of the hydroxyapatite biocoating

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.