ZRC-3197 has been developed indigenously by Cadila Healthcare Ltd as a biosimilar adalimumab of originator HUMIRA ®. Biosimilarity has been demonstrated with a comprehensive set of state-of-the-art analytical techniques to characterize the physicochemical and functional properties of ZRC-3197 in comparison with originator HUMIRA ®. The biosimilar ZRC-3197 showed indistinguishable primary and secondary structures with similar level of purity and heterogeneity as compared to that of the originator product. When analyzed, in parallel, the two products were observed to show a high degree of sameness of the carbohydrate structure and charge heterogeneity profile. Both biosimilar ZRC-3197 and the originator HUMIRA ® appeared to show highly comparable key functional properties, as assessed by in vitro cell-based assay and surface plasmon resonance technique. The biosimilar ZRC-3197 exhibited highly similar tumor necrosis factor alpha neutralizing activity as well as binding affinity for FcγRIIIa receptor compared to that of the originator product. The biosimilar ZRC-3197 was observed to show similar level of efficacy and safety profile in rheumatoid arthritis patients, when submitted to a head-to-head double-blind trial, in India, with the originator (reference) product, HUMIRA ®. Based on the demonstrated biosimilarity, market authorization has been granted for ZRC-3197, as a biosimilar of originator HUMIRA ® , in India. Here, we report the characterization of physicochemical and functional properties of the biosimilar ZRC-3197 and originator HUMIRA ® .
Effects
of diesel soot composition and accumulated vehicle mileage
on soot oxidation characteristics were examined. Four soot samples
were extracted from the crankcase oils of diesel engines that had
accumulated different mileages. Carbon black was used as a comparative
example. Soot structure was studied in situ using X-ray diffraction
as it was oxidized to temperatures as high as 700 °C. The soot
from older engines exhibited a higher increase in lattice spacing
(d
002) with an increase in temperature
that resulted in soot samples being at lower temperatures, thereby
reducing the oxidation resistance. Composition of the residues after
oxidation was studied using X-ray diffraction, energy-dispersive spectroscopy,
and X-ray absorption near-edge structure. Oxidation residue of the
soot samples is made up of decomposed lubricant additives compounds
and debris from wear and tribofilms. XRD phase analysis showed that
crystalline compounds in soot are CaSO4, CaZn2(PO4)2, Ca3(PO4)2, Zn3(PO4)2,
and ZnO. The turbostratic structure of all the soots irrespective
of engine age is similar prior to oxidation; however, the embedded
crystalline and amorphous species in the soot change with accumulated
mileage. Surface area of the soot measured using BET was found to
be inversely proportional to the weight of residue.
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