A total of 10 bacterial strains represented as from SB01 to SB10 were isolated from a petrolium-contaminated sludge, and their potential of degrading pyrene (PYR) was investigated on the substrates pyrene (MS1) , pyrene plus glucose (MS2), and pyrene plus phenanthrene (MS3). The results showed that on MS1, the degradation rate of PYR by SB01 was the highest, with 30.4% of PYR degraded after 5 days. On MS2, the degradation rate of PYR by SB09 was the highest, being 37.7% after 5 days, while on MS3, 50.2% of PYR was removed by SB01. The degradation of PYR by SB01 and SB03 was inhibited by glucose, which was more obvious for SB01, but no significant difference was observed among SB02, SB07, SB08 and SB10. The biodegradation rate of PYR by all the ten bacterial strains was enhanced on MS3, and that by SB10 was increased by 29.8%. For SB04 and SB09, the biodegradation rate of PYR had no significant difference between MS1 and MS2, but for other strains, the stimulation effect of phenanthrene on PYR degradation was higher than that of glucose.

Biologics : targets & therapy

Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product

Article

作者: Bose, Sandip ; Singh, Sanjay Kumar ; Almal, Suhani ; Pokalwar, Santosh ; Ranbhor, Ranjit Sudhakar ; Gupta, Shivika

BACKGROUND:

Cell surface protein, CD20, is extensively expressed on the surface of B cells. Antibodies targeting CD20 protein are being used to treat B-cell malignancies and B-cell mediated autoimmune diseases. Considering the cost of therapy with innovator monoclonal antibodies for these diseases, development of biosimilar products for the treatment of such diseases provides affordable solution to rising healthcare costs.

MATERIALS AND METHODS:

Reference products of rituximab (six batches) were procured and stored as per manufacturer's instructions. Cell lines used in bioassay were procured from American Type Culture Collection and all other reagents used for analysis were of analytical grade. Primary structure was studied by intact mass analysis, peptide fingerprinting, peptide mass fingerprinting and sequence coverage analysis. Higher order structure was studied by circular dichroism, ultraviolet-visible spectroscopy, fluorescence spectroscopy, and disulfide bridge analysis. Different isoforms of reference product and SB-02 were identified using capillary isoelectric focusing and capillary zone electrophoresis. Glycosylation was studied by N-glycan mapping using LC-ESI-MS, point of glycosylation, released glycan analysis using ultra performance liquid chromatography (UPLC). Product related impurities such as oligomer content analysis and oxidized impurities were studied using size exclusion chromatography and reverse phase high performance liquid chromatography, respectively.

RESULTS AND CONCLUSION:

Here, we report physicochemical and biological characterizations of Sun Pharma's proposed biosimilar (SB-02) to rituximab, a monoclonal anti-CD20 antibody approved for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. SB-02 and rituximab exhibited indistinguishable primary as well as higher-order structure upon analyzing with the array of analytical and extended characterization methods according to statistical methods. The molecule also displayed comparability to reference product in post-translational modifications and charge heterogeneity. In functional bioassays, SB-02 demonstrated comparable potency with respect to reference product. Our results indicate highly similar quality profile between SB-02 and rituximab.

100 项与 SB02 相关的药物交易

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