Anti-BSG monoclonal antibody, clone OX114 [R-PE]

Aims To assess the transfer of patients treated with originator biological therapies to biosimilar products in a large UK tertiary referral hospital reflecting practice within the National Health Service (NHS) using prospectively collected data by a hospital-based registry administered by the Biologics Steering Group (BSG). Methods We analysed data collected prospectively in a hospital-based registry in a large NHS tertiary referral hospital in the UK. The registry was administered by the hospital's BSG, which considered requests for patients to remain on or revert to originator products. The registry contained prospectively collected data on patients switching therapy from an originator to a biosimilar. The data included clinical circumstances or rationale for each request, whether it was granted, and the results of clinical reviews at 3-6 months. Results In a 12-month period, we identified 1299 patients who could switch to the respective biosimilar and, of these, 1196 (92%) did so. Of the 260 patients taking infliximab, 250 (96%) switched to infliximab biosimilar; of the 390 patients taking etanercept 50 mg, 298 (76%) switched to etanercept 50 mg biosimilar; and of the 649 patients taking rituximab, 648 (99%) switched to rituximab biosimilar. The BSG received 39 applications: 12 (out of 39) applications were to remain on the originator and 27 (out of 39) were to switch back to the originator. Of the applications to remain on the originator 10 (out of 12) were approved. At 3-6 month review, 2 of these approvals reported continued efficacy, 3 switched to the biosimilar, 3 switched to an alternative therapy and 2 stopped treatment. Two (out of 10) applications were not approved, both applicants reported efficacy with the biosimilar at follow up. Of the 27 applications to switch back to the originator, 16 (out of 27) applications were approved. At 3-6 months, 9 (out of 16) applicants reported regain of efficacy, 6 (out of 16) reported cessation of reported adverse effects and 1 (out of 16) switched to alternative therapy. Eight (out of 27) applications were not approved, and, at point of follow up, 50% reported efficacy with the biosimilar and 50% had switched to an alternative therapy. Three (out of 27) applications were withdrawn by the clinical team as efficacy was achieved with the biosimilar. Conclusion We have set up a system within a busy NHS clinical practice to successfully switch patients to biosimilars, and established a mechanism to guide decisions on continuing with or reverting back to the originator. Such a system could be of use more broadly within the NHS and other health care systems.

Lignocellulolytic enzymes from low-cost sources are gaining attention as a tool to reduce production costs. Such enzymes can be obtained sustainably by diverse fungal strains via solid-state fermentation (SSF) of lignocellulosic-derived residues as substrates. Besides, these enzymes allow hydrolyzing the same residue, releasing fermentable sugars that can be transformed into value-added products. This study shows a two-stage valorization approach for the lignocellulosic leftover brewer's spent grain (BSG): first, by producing lignocellulolytic enzymes through the SSF of BSG using three fungal strains and, second, by using the self-produced enzymes to hydrolyze the same BSG and obtaining sugar-rich hydrolysates that serve as an alternative carbon source for polyhydroxyalkanoates (PHA) production. From the evaluated set,Aspergillus nigerandThermoascus aurantiacusproduced the highest xylanase activities compared withTrichoderma reesei(268 +/- 24, 241 +/- 10, and 150 +/- 24 U per gram of dry BSG, respectively).Also,A. nigerextracts resulted in the most effective for releasing sugars from BSG, obtaining up to 0.56 g per gram of dry BSG after 24 h without any pretreatment needed. Thus, the sugar-rich hydrolysate obtained withA. nigerwas used as a source for producing PHA by using two bacterial strains, namely,Burkholderia cepaciaandCupriavidus necator. Maximum PHA yield was achieved by usingC. necatorafter 48 h with 9.0 +/- 0.44 mg PHA center dot g(-1)dry BSG. These results show the significant potential of BSG as raw material for obtaining value-added bioproducts and the importance of multiple valorization schemes to improve the feasibility of similar residue-based systems.