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Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model
Biologicals. 2024 Mar 26;86:101764. doi: 10.1016/j.biologicals.2024.101764. Online ahead of print.ABSTRACTLeptospira interrogans serovar Hardjo is a long slender bacterium of size 0.1-0.3 μm × 5-50 μm. It is one of the major causes of bovine leptospirosis and is of economical importance because of the reproductive failure, still birth, abortion, and reduced productivity in cattle. It is also a zoonotic disease-causing infection in humans characterized by headaches, fever, chills, sweats and myalgia, lethargy, aching joints, pulmonary haemorrhages, and death in severe cases. Control of the disease involves antibiotic the...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 27, 2024 Category: Biotechnology Authors: S David Inbaraj Sophia Subbaiyan Anbazhagan M Karikalan R Saravanan K Nagaleekar Viswas Prasad Thomas Pallab Chaudhuri Source Type: research

Standards for fecal microbiota transplant: Tools and therapeutic advances
Discussion included a focus on the evaluation of safety, efficacy, clinical trial design, reproducibility and accuracy in obtained microbiome measurements and data reporting, and the potential for standardization across these areas. It also focused on increasing the application potential and visibility of FMT beyond treating C. difficile infections.PMID:38518435 | DOI:10.1016/j.biologicals.2024.101758 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - March 22, 2024 Category: Biotechnology Authors: Ilia Belotserkovsky Lisa M Stabryla Monique Hunter Jessica Allegretti Benjamin J Callahan Paul E Carlson Phillip J Daschner Maryam Goudarzi Cyril Guyard Scott A Jackson Krishna Rao Stephanie L Servetas Harry Sokol Jennifer A Wargo Shawn Novick Source Type: research

pH inactivation of SARS-CoV-2 and SARS-CoV in virus spiked protein A eluates from a mAb purification process
Biologicals. 2024 Mar 14;86:101753. doi: 10.1016/j.biologicals.2024.101753. Online ahead of print.ABSTRACTBiopharmaceutical manufacturing processes may include a low pH treatment step as a means of inactivating enveloped viruses. Small scale virus clearance studies are routinely performed using model enveloped viruses such as murine leukemia virus to assess inactivation at the pH range used in the downstream manufacturing process. Further, as a means of bioburden reduction, chromatography resins may be cleaned and stored using sodium hydroxide and this can also inactivate viruses. The susceptibility of SARS-CoV-2 and SARS-...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 16, 2024 Category: Biotechnology Authors: Hannah Limburg Marie Schwerdtner Eileen Wilson Bernhard Roth Jean-Pol Cassart Anke-Dorothee Werner Anne Harbig Eva B öttcher-Friebertshäuser Anne Stokes Source Type: research

Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide
This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph. Direct calibration of the candidate standard resulted in an assigned content of 1.02 mg per vial. Based on the study results the candidate standard was judged suitable to serve as the first IPRS for teriparatide for identification and assay by HPLC.PMID:38479212 | DOI:10.1016/j.biologicals.2024.101755 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - March 13, 2024 Category: Biotechnology Authors: Gaurav Pratap Singh Jadaun M Kalaivani Mukesh Kumar Gyanendra Nath Singh Rajeev Singh Raghuvanshi Parveen Jain Participants of the Study Source Type: research