PharmaNet Development Group now offers analytical structure elucidation, characterization, profiling, and similarity assessment through an alliance with Novatia, a company located in Princeton, NJ.

 

Novatia’s scientific experts are highly specialized in applying NMR and mass spectrometry to characterize, profile, and elucidate biologics. For biosimilars, they can also conduct comparative analyses with a reference product.

 

Elucidation uncovers the molecular identities of any unexpected differences revealed during peptide mapping. Elucidation is a complex art, rarely offered outside Novatia.

 

Characterization is conducted using mass spectrometry to determine molecular weight. This technique can even confirm the identity of less complex biologics. Nuclear magnetic resonance can also be applied to get a rapid, qualitative estimate of structural similarity.

 

Profiling is a three-step process combining two analytical techniques and a mapping step:

 

1.	LC-MS is conducted to obtain detailed information on impurities and integrity. This provides insight into manufacturing process issues that may need correcting, as well as identifying impurities listed in a pre-populated database of impurities.
2.	Multidimensional NMR methods are applied to evaluate chemical bonds, molecular connectivity, and spatial interactions. The resulting NMR fingerprint is compared to the reference product to assess similarity and areas of concern.
3.	Peptide mapping is achieved through tryptic digests to provide an understanding of what pieces of the molecule are present. This is also useful in ascertaining other potential modifications, such as, glycosylation and any unexpected items present upon comparison to the reference product maps.

 

Through Novatia, PDGI offers analytical characterization technologies to determine primary, secondary, and tertiary protein structure as well as the extent of glycolsylation present on a biologic molecule. A written Similarity Assessment report can also be created to summarize points of similarity and dissimilarity between a molecule and a reference product.

To learn more about Novatia, please click here.