Sandle T.,Bio Products Laboratory Ltd. |
Saghee M.R.,Gland Pharma
Journal of Commercial Biotechnology | Year: 2011
This article, written from an industry perspective, examines the current trend towards the implementation of single-use disposable technologies in the biopharmaceutical and biotechnology sectors. Single-use technologies are generally sterile, plastic disposable items implemented to replace traditional pharmaceutical processing items that require recycling, cleaning and in-house sterilisation. The forces driving the technological change are a mix of process efficiencies (including cost reduction) and sterility assurance. This article examines the advantages of some single-use systems used for aseptic processing, although in doing so a cautionary approach is adopted, particularly with regard to the validation requirements and practical considerations when such technologies are implemented. © 2011 Macmillan Publishers Ltd.
Srikanth R.,Gland Pharma |
Raghunadha Reddy D.,Gland Pharma |
Venkatesan C.S.,Gland Pharma
International Journal of Pharma and Bio Sciences | Year: 2013
A new simple, accurate and sensitive HPLC pre-column derivatisation method for the low level determination of tert-butylamine in Tigecycline drug substance has been developed. tert-butylamine may be present at a trace level in the Tigecycline drug substance, which is used as a reagent in the manufacturing process of Tigecycline. Chromatographic separations were accompanied under isocratic conditions using a Shimadzu HPLC with UV detection and a simple o-phthalaldehyde (OPA) derivatisation technique. The method has been fully validated and the limit of detection & quantification for tert-butylamine were 2.8ppm & 8.5ppm respectively. The method was linear over the range (8.5-1561μg/mL, n=7, r = 0.99993) of the working sample concentration of 20mg/mL. The precision, accuracy and ruggedness of the method are presented.
Sastry R.V.R.P.,Institute of Chemical Technology |
Sastry R.V.R.P.,Gland Pharma |
Venkatesan C.S.,Gland Pharma |
Sastry B.S.,Gland Pharma |
Mahesh K.,Gland Pharma
Journal of Pharmaceutical and Biomedical Analysis | Year: 2016
Pralatrexate (PTXT) is an antineoplastic folate analog and the chemical name is (2S)-2-[[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl] benzoyl] amino] pentanedioic acid. Degradation products of PTXT drug product (DP) under different forced degradation conditions have been studied using LC-PDA and LC–MS techniques. PTXT DP was subjected to forced degradation under the conditions of hydrolysis, photolysis, oxidation, and heat in accordance with ICH guidelines. The LC–MS compatible HPLC method was developed and stressed solutions were chromatographed on reversed phase HPLC. The degradation products were monitored at a wavelength of 242 nm. Stress study revealed that PTXT was sensitive towards acid, alkali, peroxide, light and heat. The degradation impurities (I–IX) were identified and characterized using LC-PDA and mass spectral data. © 2016 Elsevier B.V.
Orr S.,Gland Pharma |
Pittock J.,Australian National University |
Chapagain A.,WWF UK |
Dumaresq D.,Australian National University
Global Environmental Change | Year: 2012
Proposed dam construction in the Lower Mekong Basin will considerably reduce fish catch and place heightened demands on the resources necessary to replace lost protein and calories. Additional land and water required to replace lost fish protein with livestock products are modelled using land and water footprint methods. Two main scenarios cover projections of these increased demands and enable the specific impact from the main stem dam proposals to be considered in the context of basin-wide hydropower development. Scenario 1 models 11 main stem dams and estimates a 4-7% increase overall in water use for food production, with much higher estimations for countries entirely within the Basin: Cambodia (29-64%) and Laos (12-24%). Land increases run to a 13-27% increase. In scenario 2, covering another 77 dams planned in the Basin by 2030 and reservoir fisheries, projections are much higher: 6-17% for water, and 19-63% for land. These are first estimates of impacts of dam development on fisheries and will be strongly mediated by cultural and economic factors. The results suggest that basic food security is potentially at a high risk of disruption and therefore basin stakeholders should be fully engaged in strategies to offset these impacts. © 2012 Elsevier Ltd.
Schroth G.,Federal University of Pará |
McNeely J.A.,Gland Pharma
Environmental Management | Year: 2011
Trade-offs between ecosystem conservation and agricultural production can more easily be addressed by shifting the view from the plot scale to the scale of the landscape and integrating biodiversity friendly land use systems into development strategies. The provision of ecosystem services such as watershed protection and carbon sequestration by natural and complex agro-ecosystems can play an important role in making such integrated landscape approaches viable. This special issue brings together papers that were presented at a symposium on agroforestry and landscape scale conservation at the Second World Agroforestry Congress in Nairobi in August 2009. It is divided into two sections focusing on: (1) the biological mechanisms and implications of landscape scale conservation strategies as influenced by land use, especially agroforestry; and (2) the economic drivers and public policies that determine to a large extent the success of agroforestry-based landscape conservation strategies. The contributions provide evidence both for the potential and limitations of agroforestry in landscape scale conservation and development strategies and highlight the importance of economic incentives and policies to promote integrated landscape solutions. This introductory paper summarizes and discusses the contributions and concludes with policy recommendations and research needs. © 2011 Springer Science+Business Media, LLC.
PubMed | Gland Pharma
Type: | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2016
Pralatrexate (PTXT) is an antineoplastic folate analog and the chemical name is (2S)-2-[[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl] benzoyl] amino] pentanedioic acid. Degradation products of PTXT drug product (DP) under different forced degradation conditions have been studied using LC-PDA and LC-MS techniques. PTXT DP was subjected to forced degradation under the conditions of hydrolysis, photolysis, oxidation, and heat in accordance with ICH guidelines. The LC-MS compatible HPLC method was developed and stressed solutions were chromatographed on reversed phase HPLC. The degradation products were monitored at a wavelength of 242nm. Stress study revealed that PTXT was sensitive towards acid, alkali, peroxide, light and heat. The degradation impurities (I-IX) were identified and characterized using LC-PDA and mass spectral data.
News Article | June 10, 2009
VCCircle reports that Evolvence India Life Sciences Fund (EILSF) has invested Rs 25 crore in Chennai-based pharmaceutical company, Anjan Drugs Pvt. Ltd. With $150 million worth assets under management (AUM) the fund provides growth capital to Indian pharmaceutical and biotechnology companies. Last the year, the fund had invested $30 million in the Hyderabad-based advanced drug delivery mechanism company, Gland Pharma. EILSF has also invested about $5 million in Bangalore-based cancer centre network, Health Care Global. About two months back, Indian Angel Network invested $500,000 in Karmic Life Sciences, Mumbai-based oncology focused contract research organisation (CRO). Similarly, Rx HealthCare Magic, which runs a healthcare portal HealthcareMagic.com, raised Series A funding of $2.5 million from Accel India in February this year. Among other merger and acquisition deals include diagnostic chain Metropolis’ acquisition of two pathlabs in northern India. Yash Birla Group acquired a majority stake in Kerala Vaidyashala, in January. Recently, Sabre Capital too set up a company called Spring Healthcare Ltd through which it plans to make investments of around Rs 250 crore in the Indian healthcare space.
News Article | October 27, 2016
HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has entered into a strategic collaboration with Gland Pharma, a globally recognized developer and manufacturer of sterile dosage forms, to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs). The portfolio is a mix of filed ANDAs pending approval by the US Food and Drug Administration (USFDA) and AND
News Article | December 5, 2016
BOCA RATON, Fla., Dec. 5, 2016 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into a multi-product marketing agreement with development and manufacturing partner Gland Pharma Limited for seven (7) injectable products. Under the terms of this...