Author: Dakshinamurthy, Pravin Kumar ; Dhere, Rajeev ; Reddy, PeddiReddy Shrinivas ; Dake, Manjusha Sudhakar ; Pal, Jayanta ; Divase, Ambika ; Chahar, Digamber Singh ; Kamat, Chandrashekhar ; Nawani, Neelu ; Pisal, Sambhaji

AbstractCurrent postexposure prophylaxis of rabies includes vaccines, human rabies immunoglobulin (RIG), equine RIG, and recombinant monoclonal antibodies (mAb). In the manufacturing of rabies recombinant mAb, charge variants are the most common source of heterogeneity. Charge variants of rabies mAb were isolated by salt gradient cation exchange chromatography (CEX) to separate acidic and basic and main charge variants. Separated variants were further extensively characterized using orthogonal analytical techniques, which include secondary and tertiary structure determination by far and near ultraviolet circular dichroism spectroscopy. Charge and size heterogeneity were evaluated using CEX, isoelectric focusing (IEF), capillary‐IEF, size exclusion chromatography, sodium dodecyl sulfate polyacrylamide gel electrophoresis, and western blotting. Antigen binding affinity was assessed by enzyme linked immuno‐sorbent assay and rapid florescence foci inhibition test. Results from structural and physicochemical characterizations concluded that charge variants are formed due to posttranslational modification demonstrating that the charge heterogeneity, these charge variants did neither show any considerable physicochemical change nor affect its biological function. This study shows that charge variants are effective components of mAb and there is no need of deliberate removal, until biological functions of rabies mAb will get affected.

01 Jun 2024·Journal of Craniofacial Surgery

Ptosis Caused by Local Injection of Human Rabies Immunoglobulin

Article

Author: Li, Shuangle ; Deng, Jiaping

Rabies is a fatal zoonotic disease. Patients with grade III injuries after exposure need timely injection of rabies vaccine and human rabies immunoglobulin treatment. This article introduces the diagnosis and therapy of ptosis caused by local injection of human rabies immunoglobulin in a patient bitten by a dog.

30 Nov 2022·Human Vaccines & Immunotherapeutics

Safety and clinical efficacy of human rabies immunoglobulin in post exposure prophylaxis for category III animal exposures

Article

Author: Fotedar, Nidhi ; Kumari, Nitu ; Narayana, D. H. Ashwath ; Haradanhalli, Ravish S.

The human rabies immunoglobulin (HRIG) is a life-saving immune biological essential for all category III animal exposures. It provides neutralizing antibodies at the site of exposure until the body can produce vaccine-mediated antibodies. We conducted this study to determine the safety and clinical efficacy of an HRIG being used presently for post-exposure prophylaxis (PEP) and to strengthen the existing evidence for its further usage. We conducted a prospective cohort study in 123 subjects with category III animal exposures at the KIMS Hospital and Research Center, Bangalore, India. Post-exposure prophylaxis (PEP) with wound toilet, a single application of HRIG, and a full course of anti-rabies vaccination were provided to all the study subjects. The volume of HRIG was calculated according to the body weight, and all the wounds were infiltrated as was anatomically feasible. All the study subjects were followed up for immediate and delayed adverse events (AE), both local and systemic. Subsequently, all the subjects were followed up for 6 months to demonstrate the clinical efficacy of PEP. The incidence of AEs was 11.4% including local pain, erythema, itching, headache, body ache, fever, and malaise. All AEs were mild and subsided without any complications. All the study subjects were healthy and alive after 6 months following the administration of HRIG, along with a full course of anti-rabies vaccine. Our study provides evidence of safety and clinical efficacy of HRIG for category III animal exposures and supports its continued usage.

100 Deals associated with Human Rabies Immunoglobulin(Hualan Biological Engineering)

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Indication	Country/Location	Organization	Date
Rabies	CN	Hualan Biological Engineering, Inc.	04 Feb 2008

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