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BAT1706 is a proposed biosimilar of bevacizumab (BEV). The objective of this phase I clinical trial was to establish pairwise similarity between BAT1706, US-sourced BEV (US-BEV), and EU-sourced BEV (EU-BEV) after a single intravenous (IV) infusion in healthy male subjects. This phase I clinical trial was a randomized, double-blinded, three-arm study in 128 healthy adult male subjects. Every subject received a single IV infusion of 1 mg/kg of study drug and was subsequently monitored for 14 weeks. Pharmacokinetic, safety, and immunogenicity data were collected from each patient. The primary pharmacokinetic endpoint of this clinical study was area under the concentration curve from time zero to infinity (AUC0–inf). Biosimilarity of the study drugs was confirmed if the two-sided 90% confidence interval (CI) ratios of the geometric means for the three pairwise comparisons were contained within the range 80–125%. Other pharmacokinetic parameters including area under the concentration curve to time t (AUC0–t), maximum concentration of drug in plasma (Cmax), half-life (t½), and time to Cmax (tmax) were also measured. The pharmacokinetic parameters were comparable for the three drug products evaluated. The 90% CI for the AUC0–inf was 99–112% for BAT1706 versus EU-BEV, 97–110% for BAT1706 vs US-BEV and 92–104% for EU-BEV versus US-BEV comparisons, respectively, demonstrating biosimilarity. There were no significant adverse events attributable to BAT1706, as compared to EU-BEV and US-BEV. BAT1706 demonstrated a similar safety profile to EU-BEV and US-BEV. In addition, no anti-drug antibody positive result was reported for any subject included in the study. In this study, BAT1706, a proposed biosimilar of BEV, was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence, safety, and immunogenicity in healthy subjects after a single IV infusion. NCT03030430.

The product quality of selective laser melting (SLM) is closely related to the alloy powder characteristics, including the size distribution and the oxygen content. In this work, the 316L stainless steel powder was prepared by a vacuum atomization furnace and sieved into a normal-sized distribution range from 15 to 53 μm with a median diameter of 37.4 μm, and a fine-sized distribution range from 10 to 38 μm with a median diameter of 18.9 μm. Then they were mixed with each other in different proportions. The results show that, under the condition of the same SLM parameters, the SLM part, with adding a large amount of fine-sized powder, has a lower density and strength, as well as more holes and spheroidized particles, compared with the SLM part with adding a small amount of finer-sized powder. Furthermore, the 316L stainless steel powder with a high oxygen content was prepared by a non-vacuum atomization furnace. Although the 316L stainless steel powder with a high oxygen content can be evenly spread in the SLM process, the surface layer of the powder is easy to form an oxide film during the cooling and solidification of powder inside the molten pool. Under the action of thermal stress, the small crack forms and expands along the oxide film, eventually leading to large cracks inside the melt channel.

In this work, a 2D axisymmetric model of gas atomization at unsteady state that accounts for break-up and solidification is used to simulate laser melting of gas atomized powder. With an optimal nozzle width of 0.6-1 mm and a nozzle angle of 30-32°, the yield of fine 15-45 μm stainless steel powder, suitable for selective laser melting, is shown to increase from 20% to 35%. The effect of laser power on the melting channel width, microstructure, and mechanical properties of the sample is also investigated.