National Institute of Biologicals

Greater Noida, India

National Institute of Biologicals

Greater Noida, India
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Ahuja K.,National Institute of Biologicals | Satapathy R.,National Institute of Biologicals | Gulati G.,National Institute of Biologicals | Singh S.,National Institute of Biologicals
Asian Journal of Transfusion Science | Year: 2017

Background: The antiglobulin test is used to determine red blood cells (RBCs) having surface-bound immunoglobulin G (IgG) and/or complement (C3b, C3d, C4b, and C4d) free in serum or attached to antigens on RBCs. In such circumstances, the quality of the anti-human globulin (AHG) which is used in routine cross-match/indirect agglutination test plays a vital role in blood transfusion medicine. For potency testing of polyspecific AHG, it is recommended by the Food and Drug Administration and the Centre for Biologics Evaluation and Research to use fresh O +ve RBCs within 1 hr of collection for sensitization with anti-C3d. Aim and Objective: Freshly collected red cells were cryopreserved and stored at a temperature of -70°C for 30 days. These cells were then sensitized with C3d and IgG after deglycerolization. Their viability was checked by potency testing using polyspecific AHG-containing anti-C3d and anti-IgG. Materials and Methods: Anonymous left over fresh whole blood samples were collected from the Indian Red Cross Society, New Delhi, with CPDA as an anticoagulant, and the samples were treated within 1 h of collection. ABO and Rh (D) phenotyping was performed by test tube method. RBCs and plasma from the same donor were used throughout the study. Results: In this comparative study, fresh RBCs (O +ve) maintained their viability after cryopreservation and were also found to be suitable for sensitization with C3d and IgG. The potency of polyclonal AHG did not differ significantly with fresh RBCs and cryopreserved RBCs for 30 days. Conclusion: This result suggests that the sensitization of fresh RBCs with IgG and C3d is not affected by using cryopreserved cells for 30 days. © 2017 Asian Journal of Transfusion Science.


Deodia S.S.,Dr Hari Singh Gour University | Soni G.R.,National Institute of Biologicals | Kashyap V.K.,National Institute of Biologicals | Jain N.K.,Dr Hari Singh Gour University
Indian Journal of Pharmaceutical Education and Research | Year: 2010

Clinical trials are essential for the development of new drugs, formulations, drug delivery systems, dosage regimen, surgical and diagnostic techniques, devices and therapies. The adaptation of standard guidelines everywhere increases the credibility of data and makes it acceptable to regulatory authorities across the world. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides a unified standard for the European Union, Japan, the United States, as well as for Australia, Canada, the Nordic countries and the World Health Organization. ICH-Efficacy guidelines are relating to clinical studies in human subject. In India, the Ministry of Health along with DCGI and ICMR has come out with Good Clinical Practices (GCP-India) guidelines as ethical and scientific quality standard for the design and conduct of trials involving human subjects. India has emerged as a global hub for carrying out clinical trials and attracts the sponsors due to i) highly diverse human gene pool and strong availability of study subjects across major therapeutic segments, ii) quality data at a competitive cost, iii) high level of ICH-GCP and USFDA standard compliance, iv) favorable regulatory climate and development speed. However, a gap analysis needs to be done to scale up all the resources for clinical trials. A number of issues are bogging down the clinical trial industry in India. The challenge lies in integrating physician, regulatory authorities and pharmaceutical organizations to optimize the risk-benefit profile and to minimize the abuse/misuse of the study subjects. The study of drugs in humans needs to be logical, with sound scientific basis in both conception and execution. © APTI All rights reserved.


Grover S.S.,National Center for Disease Control | Negi S.S.,National Center for Disease Control | Negi S.S.,National Institute of Biologicals | Singh S.,National Center for Disease Control | And 2 more authors.
Biologicals | Year: 2012

The level of circulating tetanus toxin, antitoxin and their individual influence on the outcome of tetanus cases were determined in unimmunized 125 neonatal and 39 infant cases of tetanus. PHA (passive haemagglutination) test showed 40% positive cases for toxin while its absence in the remaining cases indicated of either toxin fixation to the central nervous system (CNS) or it got neutralized by antitoxin. TN (toxin neutralization) and PHA test carried out in 46 sera samples revealed a strong positive correlation (r = 0.9) showing that 35/46 (76%) and 38/46 (82.6%) samples were positive for antitoxin, respectively. 25.4% of the neonate and infant cases and 34% of the control group had a protective serum tetanus antitoxin level. 42.5% of the paired sera from unimmunized mothers and their neonates showing nonprotective antitoxin levels suggested that a high level of antitoxin is needed for transplacental transfer, although transfer may not play a decisive role in the resistance against the disease. The presence of toxin or antitoxin in the clinical cases did not affect the outcome of the disease, although in neonates, presence of toxin was found to be a bad prognostic sign. This study explicitly advocates for the need to improve the vaccination coverage strategy. © 2012 The International Alliance for Biological Standardization.


Rajput M.K.,National Institute of Biologicals | Rajput M.K.,Jawaharlal Nehru University
Genes and Genomics | Year: 2014

This review is confined to a handful and essential information on retrotransposons from various systems/hosts. The main objective of this review to explain that retrotransposons play a significant role in evolution by structuring and restructuring of genomes. The implications due to their structure and method of propagation makes them agents of genome evolution and biodiversity. The obesity of complex genomes is granted by diverse population of retrotransposons. The diversity at every level of biological organization including species, individual organism and molecules such as nucleic acid and proteins gives rise to evolution. The mechanism of regulation and activation of retrotransposons indicates that the retrotranaposons, which were earlier considered as junk, are very important for development of an organism and these elements play significant role in biological evolution. The similarity of retrotransposons with endoretroviruses brings them closer to retroviruses and helps to understand phylogenetics. The continued inheritance of retrotransposons may be due to evolutionary process that creates and preserves traits that are seemingly fitted for the functional roles they perform. © 2014, The Genetics Society of Korea and Springer-Science and Media.


Bisht A.,Indian Pharmacopoeia Commission | Singh S.,National Institute of Biologicals | Marwaha N.,Jawaharlal Institute of Postgraduate Medical Education & Research
Asian Journal of Transfusion Science | Year: 2013

A centralized hemovigilance program to assure patient safety and to promote public health has been launched for the first time in India on Dec 10, 2012 in 60 medical colleges in the first phase along with a well-structured program for monitoring adverse reactions associated with blood transfusion and blood product administration. National Institute of Biologicals (NIB) will be the National Coordinating Centre for Hemovigilance. This program will be implemented under overall ambit of Pharmacovigilance Program of India (PvPI), which is being coordinated by Indian Pharmacopoeia Commission (IPC). All medical colleges of the country will be enrolled in this program by the year 2016 in order to have a National Centre of Excellence for Hemovigilance at NIB, which will act as a global knowledge platform.


Chatterjee K.,All India Institute of Medical Sciences | Zaman S.,All India Institute of Medical Sciences | Chaurasia R.,All India Institute of Medical Sciences | Singh S.,National Institute of Biologicals | And 7 more authors.
Asian Journal of Transfusion Science | Year: 2016

Background and Objectives: This study was conducted to assess the efficacy of Mirasol pathogen reduction system for platelets aimed at preventing bacterial regrowth by spiking buffy coat pooled platelets (BCPP) with clinically relevant load of Staphylococous epidermidis. Materials and Methods: BCPP units were prepared using Teruflex BP-kit with Imugard III-S-PL (Terumo BCT, Tokyo, Japan). Two BCPP units were pooled, of which 40 ml of negative control (NC) was removed. The remaining volume of the platelet unit was inoculated with clinically relevant load of bacteria (total of 30 CFU of S. epidermidis in 1 ml); following this the platelet unit was split into two parts. One part served as positive control (PC) and the other part was subjected to pathogen reduction technique (Mirasol PRT, CaridianBCT Biotechnologies, Lakewood, CO, USA). Bacterial detection was performed using BacT/ALERT system, controls after day 1 and day 7 following inoculation of bacteria and on day 7 for Mirasol-treated unit. Results: Of the 32 treatment cycles, 28 were valid and 4 were invalid. No regrowth was observed in 96.4% (27 of 28) after treatment with Mirasol pathogen reduction system. Of four invalid tests, on two instances the NC showed growth, whereas in other 2 no regrowth was detected in 7th day PC. Bacterial screening of PCs by BacT/ALERT after 24 h of incubation was 28.6%, whereas the effectiveness increased to 100% when incubated for 7 days. Conclusions: Mirasol system was effective in inactivating S.epidermidis when it was deliberately inoculated into BCPP at clinically relevant concentrations. Such systems may significantly improve blood safety by inactivating traditional and emerging transfusion-transmitted pathogens. © 2016 Asian Journal of Transfusion Science Published by Wolters Kluwer - Medknow.


Prasad J.P.,National Institute of Biologicals | Madhu Y.,National Institute of Biologicals | Singh S.,National Institute of Biologicals | Soni G.R.,National Institute of Biologicals | And 5 more authors.
Biologicals | Year: 2016

Current study is conducted in our laboratory due to failure in quality control testing of twenty batches of Human Albumin solution in which sodium content is higher than the prescribed limit. These batches are received in short duration from indigenous manufacturer and is the first incident of failure of Human albumin preparation in sodium content of manufacturer. On request of manufacturer, study is conducted to rule out the cause. Repeat testing of each out of specification batch is conducted and a trend analysis is drawn between our findings and manufacturer's results, also study of trend analysis of manufacturer for the last one year. Trend analysis data indicated towards poor consistency of batches with major shift at various time intervals in sodium content of human albumin preparation. Further analysis rule out that non-traceable quality of standard used in the internal quality control testing by manufacturer is the root cause of the problem. © 2016 International Alliance for Biological Standardization.


Prasad J.P.,National Institute of Biologicals | Madhu Y.,National Institute of Biologicals | Mandhan A.,National Institute of Biologicals | Garg P.,National Institute of Biologicals | And 6 more authors.
Indian Journal of Clinical Biochemistry | Year: 2016

Current study is conducted to evaluate method verification of two locally available kits manufactured by DSI & BIORAD for quantitative estimation of Hepatitis B virus antibodies in human normal immunoglobulin by using International standard of National Institute of Biological Standards and Control. Four analyst perform five sets of test in duplicate analysing accuracy, precision, and limit of detection, sensitivity and specificity. Our results suggest that both DSI and BIORAD kits fulfil the validation criteria and are sensitive to detect up to 10 mIU concentration precisely and accurately. DSI kit is more precise at concentration 100 mIU and economically 4–5 times cheaper in local market; on the other hand, BIORAD kits provide larger detection range up to 1000 mIU. © 2016 Association of Clinical Biochemists of India


Rajput M.K.,National Institute of Biologicals
Journal of Clinical and Diagnostic Research | Year: 2016

This review is confined to triplex nucleic acid testing (NAT) assays to be used on fully automated platform. Around the world, these assays are being used at various transfusion medicine centres or blood banks to screen blood units for HBV, HCV and HIV. These assay systems can screen up to 1000 blood units for HBV, HCV and HIV simultaneously in a day. This area has been dominated by mainly two manufacturers: M/s Gen-Probe-Novartis and M/s Roche Molecular Systems. The triplex NAT assay systems of both manufacturers are licensed by United States Food and Drug Administration. There is not much awareness about the technology and procedures used in these assays. The main objective of this review is to create awareness about the technology and procedure of these assays. © 2016, Journal of Clinical and Diagnostic Research. All rights reserved.


PubMed | National Institute of Biologicals
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2016

Current study is conducted in our laboratory due to failure in quality control testing of twenty batches of Human Albumin solution in which sodium content is higher than the prescribed limit. These batches are received in short duration from indigenous manufacturer and is the first incident of failure of Human albumin preparation in sodium content of manufacturer. On request of manufacturer, study is conducted to rule out the cause. Repeat testing of each out of specification batch is conducted and a trend analysis is drawn between our findings and manufacturers results, also study of trend analysis of manufacturer for the last one year. Trend analysis data indicated towards poor consistency of batches with major shift at various time intervals in sodium content of human albumin preparation. Further analysis rule out that non-traceable quality of standard used in the internal quality control testing by manufacturer is the root cause of the problem.

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