Current Trends in Biotechnology and Pharmacy

Comparison of Analytical Method validation guidelines used for release, stability in Biosimilar Manufacturing process.

2023-09-15T23:13:50+00:00

Analytical method validation is the process of verifying a method for its purpose of fit, whether it suffices its intended application or not. Analytical method validation is a mandatory requirement to be fulfilled for measuring critical quality attributes (CQA) during the manufacturing process to get a drug approval for human, and veterinary use. As the drug approval process differs from one country to another in a similar way method validation guidelines also differ from one country to another, these requirements will be added as your country of approval differs, In the present review an attempt was made to bring all method validation guidelines in a comparative manner by comparing country-specific requirements these countries/organizations hold the major pharma market and the Stringent regularity countries. The paper majorly focuses on the analytical method used in the Biosimilar manufacturing process and its validation approach by comparing the method validation guidelines from the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), USA, European Medicines Agency (EMA), Japan and India with the CQAs monitored during the biosimilar manufacturing process.

Improved, Efficient and Reliable Plant Regeneration Protocol for a Recalcitrant Black Rice (Oryza sativa cv. Chakhao amubi)

2024-03-08T01:49:46+00:00

Rice tissue culture is very well established for the Indica and Japonica varieties in white rice. Black rice is recalcitrant for the regeneration due to their pigment. Since, there is a limited genetic transformation protocol available for the black rice so crop improvement efforts have not made so much progress. Here, we have developed an improved, efficient and reliable regeneration protocol for Chakhao amubi cultivar of black rice using mature seeds as an explant and through somatic embryogenesis pathway. The effects of growth regulators, gelling agent, and photoperiod, and various stages of complete protocol is well established. The regeneration protocol developed in this study will be well suited for introducing the agronomical important genes and functional genomic studies in black rice.

Green Synthesis Of silver Nanoparticles Using Elettaria cardamomum: Characterization and Antimicrobial Potential

2024-04-24T05:57:34+00:00

Recently, the ecofriendly production of silver nanoparticles (AgNPs) has become a focal point for researchers. In India, the quest for costeffective, nonhazardous compounds suitable for reducing and stabilizing AgNPs has been limited. This study explores the synthesis of AgNPs using Elettaria cardamomom seed extract. We evaluated the efficiency of silver ion (Ag+) reduction and AgNP formation from an aqueous AgNO3 solution combined with the cardamom seed extract. Characterization of the AgNPs was carried out through UVvis spectroscopy, XRD, SEM, EDAX, and FTIR. This research presents a practical and efficient strategy for AgNP production. A formulation using readily available 1 mm aqueous AgNO3, known for its accessibility and therapeutic properties, was created with cardamom seed extract serving as both a capping and reducing agent. Within 30 minutes, the silver ions were reduced to AgNPs, resulting in a change from golden to dark brownreddish tint. Various analytical techniques, including UVvis spectroscopy and Fouriertransform infrared spectroscopy, were employed for characterization. This study introduces an affordable, robust, and renewable method using E. cardamomum seeds for AgNP synthesis, which is entirely ecofriendly and devoid of toxic chemicals. AgNPs hold promise for applications in cancer treatment and diagnosis, setting them apart from other noble metals.

Targeting Glucose Metabolism in Diabetes-A Homology Modeling and Active Site Identification for Inositol Monophosphatase

2023-11-30T11:31:13+00:00

Diabetes is a degenerative disease caused by either the body’s inability to use insulin adequately or the pancreas’s failure to release enough insulin. Diabetes is a glucose metabolic imbalance produced by the phosphodiesterase family of protein inositol monophosphatase (IMPase). Inositol monophosphatase, an enzyme involved in the phosphatidylinositol signalling pathway, is encoded by the IMPA1 gene. Homology Modelling is used to create a 3D model of the IMPA1 protein (target). The FASTA sequence for the IMPase protein (265 amino acids) (Uniprot ID H0YBL1) is obtained from the Uniprot server. Jpred, and NCBI Blast servers are used to search for templates. Based on the query coverage (92%) and Escore, the protein with the PDB ID1IMA is identified as a potential template. The structural alignment (by ClustalW) submitted to the SWISSMODEL service yields a 3D model. The Swiss PDB viewer is used to minimise energy (E = 10099.60 kcal/mole). Procheck, ERRAT, and the VERIFY 3D server validate the model. The Ramachandran plot of the 3D model indicates that 93.5% of the amino acids are in the allowed region and none are in the forbidden region. The ERRAT result shows an overall quality factor of up to 96.17% for nonbonded atomic interactions. According to NCBI blast, the conserved domain is between 60 245 amino acids. The servers (ACTIVE SITE FINDER,) indicate binding pockets in the hydrophobic area, and Swiss dock is used to determine the active residues by protein small ligand (Natural substrate, Fructose Biphosphatase FBPase receptor ) docking to identify the active site residues (Asp 90 and Thr 95) based on visualisations and a Swiss energy value. The glucose metabolism can be stopped by blocking these residues.

Phytochemical, Toxicological, and Anti-Hyperglycemic Evaluation of Pennisetum purpureum in Sprague-Dawley Rats

2023-10-31T00:33:40+00:00

Many herbal extracts have been used for preventing and managing diabetes. In recent times it was documented that the herbal extracts in traditional Indian medicine are clinically effective in treating sugar imbalances associated with diabetes mellitus. Although it was considered that several bioactivities and phytochemicals have been attributed and it confirmed in terms of their toxicological profile and anti-diabetic activity. Herbal formulation and extract of the plant part of elephant grass plays an important role for the treatment of various diseases and disorders such as inflammation, pain, ulcer, cancer, bacterial infections, and fungal infections. Ethanolic extract of Pennisetum purpureum which was prepared by using 50%v/v and their fractions were prepared by using liquid-liquid extraction technique. There was quantitative estimation of gallic acid analyzed by HPTLC technique. The extract has been found safe at high dose through oral acute toxicity study. Antihyperglycemic activity was performed on Sprague Dawley rats by inducing the diabetes through Streptozotocin. Gallic acid was quantitatively estimated in methanolic fraction of extract and was found to be 0.13%w/w. Extract showed positive response in the treatment of diabetes which was confirmed after performing histopathology of liver and pancreas. Finally in this study, it was found that P. purpureum showed no toxicity and ameliorative changes in the blood glucose level, antioxidant level and biochemical parameters viz. triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein and very low density lipoprotein.

Formulation and Evaluation of Piroxicam Liquid Fill Formulations

2023-02-20T01:36:48+00:00

The present investigation includes the preparation and evaluation of liquid filling for mulations of Piroxicam (PXM), a non-steroidal anti-inflammatory drug, to improve its dissolution properties. Liquid fills were prepared using various excipients like polyethylene glycol 400 (PEG 400), propylene glycol (PG), and methanol as co-solvents, poly vinyl pyrrolidone (PVP K-30) as solubilizing agent, and hydroxyl propyl methyl cellulose as gelling agent. The prepared PXM liquid fills were evaluated for appearance, recrystallization, viscosity, clarity, assay and in vitro drug release studies. The compatibility of PXM and excipients in liquid fills was confirmed by FTIR. DSC studies together with XRD confirmed the absence of PXM recrystallization within the liquid fills. The viscosity of the prepared liquid fills was found to be in the range of 60.9–591.7 cps. Liquid fills containing PVP K 30 gave better dissolution properties when compared to formulations without PVP K 30, and complete PXM release was observed within 60 min for all PXM liquid fills and the PXM release from liquid fills followed diffusion mechanism. The liquid fills showed 98-102% PXM content even after 6 months time period indicating that the PXM was stable in liquid fill formulations.

A Bibliometric Analysis of Scholarly Publication on Protein Folding From 2018 to 2022

2023-07-30T00:49:49+00:00

The paper investigates the research output of protein folding published in the last five years, from 2018-2022. The source data are retrieved from the SCOPUS database and analyzed using MS Excel and VOS Viewer software. The VOSViewer software is mainly used for networking and visualization to understand the research pattern. A total of 12515 documents on protein folding are retrieved and considered for the study. The research finds that Uversky, V.N. was the most prolific protein folding author with the highest 42 publications and top 2560 global citations. The most productive countries in this field is the USA (4443 publications), followed by China (1791 publications), and Germany (1197 publications). The four hot keywords in protein folding research are protein binding, protein conformation, and metabolism, but protein folding is a burning author keyword. Most articles have been published by the CNRS (Centre National de la RechercheScientifique). This study will benefit future researchers worldwide in understanding the research pattern of protein folding.

Mapping of Global Research Performance on Molecular Docking: A Bibliometric Study

2024-04-24T06:57:31+00:00

The paper examines the global scientific literature on Molecular Docking (MD). MD is a key approach used in bioinformatics to identify and develop novel compounds towards drug discovery. This study uses the bibliometric method to analyze scientific data covered in the Scopus database from 2013 to 2022 using MS Excel, R Studio, and VOS Viewer software. A total of 12173 documents on Molecular Docking were retrieved and considered for the study. The paper provides an in-depth evaluation of the research output of MD. The research found that Muthu S. was a most prolific author in MD scientific research, with 98 publications that received 1481 global citations. The most productive countries in this field are India (4020 publications), followed by China (2675 publications), Saudi Arabia (1362 publications) and Egypt (1071 publications). The hot keywords in MD research are molecular modelling, molecular docking simulation, unclassified drug and controlled study, but Molecular Docking is the burning author keyword. The finding also shows that the publications are increasing consistently from 2013 onwards. Most articles have been published in the 'Journal of Molecular Structure'. As it is an emerging and a trending topic, it has scope for further studies. This study will benefit future researchers and practitioners worldwide in understanding the research pattern on MD and identifying the other key areas related to the topic.

Molecular Docking Analysis of Christanoate and Christene from Christia vespertilionis Plants as Potential Inhibitors of Covid-19

2023-08-28T02:56:24+00:00

Covid-19 is a global pandemic caused by SARS-CoV-2 virus that caused mortality and world economic collapse. It is almost impossible to break the chain of infection with no intervention except vaccines to prevent worsening symptoms and to build herd immunity in people. Efforts to discover a therapeutic drug to combat the virus are still ongoing. Various medicinal phyto constituents are also researched for their pharmacological action as antiviral agents against Covid-19. This study explored the antiviral potential of Christia vespertilionis bio active compounds (christene and christanoate) for treating Covid-19 using molecular docking analysis. The Covid-19 protein crystal structures (PDB ID: 6LU7, PDB ID: 6CS2, PDB ID: M1D, PDB ID: 2GHV and PDB ID: 6M71) obtained from the protein data bank were docked to christene and christanoate. The analyses were carried out using the Autodock tool 1.5.6. The control docking was done using favipiravir as the reference drug. The binding interaction of the protein and ligand was observed using the Biovia Discovery visualizer. The binding affinity and interactions indicate that the observed compounds have antiviral action suggesting their potential as Covid-19 inhibitors and can be further considered for therapeutic applications.

BZ-97: A Promising Compound Against Trypanosoma cruzi

2024-04-24T07:27:28+00:00

Chagas Disease has been considered “the most neglected among the neglected diseases.” Only two very toxic drugs developed in the 1960s have been approved to control the disease in its acute phase and are infective in the chronic stage of the illness. It is imperative to find new molecules that can act against the causative parasite, Trypanosoma cruzi. BZ-97 is a synthetic product derived from the benzimidazole scaffold. It was tested against other human parasites, showing the best activity (IC50 = 0.76 μM) towards T. cruzi intracellular stages. The effects of BZ-97 on epimastigotes of the Y strain were analyzed. Signs of changes in the parasite homeostasis were evident by acidocalcisomes alkalinization, calcium mobilization, changes in their morphology and some signs of apoptotic events with a lack of ROS production, which is a crucial advantage over the behavior of the reference drug, benznidazole. Acidocalcisomes alkalinization was evidenced through fluorescence microscopy analysis and the use of 5-[N-ethyl-N-isopropyl] amiloride (EIPA), an inhibitor of the TcNHE pump, confirmed the involvement of this proton pump in the BZ-97-mediated acidocalcisome alkalinization. BZ-97 is presented as a potential lead compound against T. cruzi that is worthy of further studies in the future.

Dunaliella salina as a Protein Expression System for the Expression of the Endolysin Lysqdvp001 Against Vibrio parahaemolyticus

2024-04-24T07:43:02+00:00

Vibrio parahaemolyticus is a gram-negative, halophilic marine pathogen that is the major cause of infections and death in aquaculture. Consumption of undercooked or raw infected seafood causes gastroenteritis in humans. Because of this rapid rise in the number of cases of vibriosis in fish and Acute hepatopancreatic necrosis disease (AHPND) in crustaceans, the dependence on antibiotics has been on the rise, leading to the occurrence of more antibiotic-resistant bacterial strains. Endolysin, a lysin derived from bacteriophage is a great alternative to antibiotics. The fact that both endolysins and the bacteriophage are both species-specific, makes them even better replacement to antibiotics. In this study, the endolysin Lysqdvp001 which has been shown to be effective against Vibrio parahaemolyticus, is expressed and purified from E. coli. Further, endolysin Lysqdvp001 is also expressed in Dunaliella salina, a microalgae that is a cheap, easy to culture protein expression system. Dunaliella salina has many nutritional benefits because of the high concentration of β-carotene. Both the purified Lysqdvp001 and the Dunaliella salina expressed Lysqdvp001 are shown to have good antimicrobial properties against Vibrio parahaemolyticus.

Biosorption of Zn (II) ion from Aqueous Solutions Using Nut Grass

2023-10-10T06:23:42+00:00

The present investigation, removal of Zn (II) ion from industry effluent was examined by using Nut grass as a biomass. The process conditions of agitation time and dosage were estimated using batch biosorption. The equilibrium data analyzed with Freundlich and Langmuir isotherms. The results revealed that removal of Zn (II) using Nut grass well followed to the Freundlich model than Langmuir model. The first order and pseudo- second order kinetic expressions were tested to find the best fit for the given kinetic data. It was observed that second order kinetics was the best fit for biosorption of Zn (II) ion. The maximum biosorption capacity of the nut grass for biosorption of Zn (II) ion was occurred at 40 mg/g.

Relative Performance of Bedside Mobility Assessment Tool 2.0 (BMAT) Over Others for Acute Care Patient Recovery

2024-04-24T07:55:43+00:00

Immobility compromises almost all of the body’s systems. Research indicates that individuals who were mobile before being admitted to the hospital may spend approximately 83% of their hospital stay in bed, and over onethird of hospitalized patients over the age of 70 are released from the hospital with a significantly higher physical limitations than prior to hospital admission. Healthcare professionals should be able to accurately assess patient’s mobility status in order to implement interventions to mobilize patients even in the presence of deficiencies. The purpose of this review is to assess the Bedside Mobility Assessment Tool 2.0 (BMAT 2.0), to objectively identify patient mobility function deficiencies and assist the healthcare team in choosing the right equipment for patients to be handled and moved safely. BMAT 2.0 is best used by the interdisciplinary team, involved in patient care, and can be recorded in the electronic health record (EHR). Further, a comparative account of other methods being practiced vis-à-vis the BMAT is given in this article.

Synthesis, Charectertisation and Antitubercular Evaluation of Pyarzoline Clubbed Thiazole Hybrids

2024-04-24T08:56:51+00:00

In our previous work, we have synthesised novel isoxazole conjugated pyrazoline derivatives by reacting isoxazolyl chalcones (1-15) with thiosemicarbazide in glacial acetic acid. From these compounds, 15 isoxazole conjugated pyrazoline carbothioamides were synthesised, compounds 24 and 25 are selected for further optimisation. In continuation to this work, pyrazoline-clubbed thiazole hybrids were synthesied by using potential antimycobacterial isoxazole conjugated pyrazoline carbothioamides – 24 and 25. The pyrazoline-1-carbothioamides- 24 (3-(isoxazol-5-yl)-5-(3,5-dimethoxyphenyl)-4,5-dihydro-1H-pyrazole-1-carbothioamide) and 25 (3-(isoxazol-5-yl)-5-(2,3,4-trimethoxyphenyl)-4,5-dihydro-1H-pyrazole-1-carbothioamide) were further optimized and synthesized eight more compounds (24a-24d, 25a-25d) which have a substituted thiazole ring. These compounds are purified by recrystallisation and charecterised by FT IR, 1 H NMR and Mass spectra. Compound 24a have shown potent antimycobacterial activity.