Intas Biopharmaceuticals Ltd

Ahmadābād, India

Intas Biopharmaceuticals Ltd

Ahmadābād, India
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Mody R.,Intas Biopharmaceuticals Ltd | Varshney B.,Intas Biopharmaceuticals Ltd | Patankar D.,Intas Biopharmaceuticals Ltd
International Journal of Risk and Safety in Medicine | Year: 2010

A second wave of blockbuster products will go off-patent between 2012-2016 in Europe and USA, triggering a rush for the approval of biosimilars or follow-on biologics. Biosimilars are approved through an abbreviated route which relies on a limited safety and efficacy data enabling biogeneric companies to develop these products at lower cost giving a price benefit to the payer. This advantage needs to be weighed against the potential risk that any variation could have with respect to safety and efficacy, especially from long-term use. The paper attempts to rationalize the current 'risk' perceptions regarding biosimilars, which have been in existence over a decade in the Indian market. The differences from the Reference product are substantial yet their safety record over a long use warrants a more 'realistic' rather than 'speculative' assessment, keeping cost-to-benefit as an important criteria and identify ways of mitigating potential risk that are perceived for biosimilar products. © 2010 - IOS Press and the authors. All rights reserved.


Rane S.S.,M. S. University of Baroda | Rane S.S.,Intas Biopharmaceuticals Ltd. | Ajameri A.,Intas Biopharmaceuticals Ltd. | Mody R.,Intas Biopharmaceuticals Ltd. | Padmaja P.,M. S. University of Baroda
Journal of Pharmaceutical Analysis | Year: 2012

Rapid and sensitive reversed phase high performance liquid chromatography (RP-HPLC) and ultra performance liquid chromatography (RP-UPLC) method with UV detection has been developed and validated for quantification of parathyroid hormone (PTH) in presence of meta-cresol as a stabilizer in a pharmaceutical formulation. Chromatography was performed with mobile phase containing 0.1% Trifluoroacetic acid (TFA) in MilliQ water and 0.1% TFA in acetonitrile with gradient program and flow rate at 0.3 mL/min for HPLC and 0.4 mL/min for UPLC. Quantification was accomplished with internal reference standard (qualified against innovator product and National Institute for Biological Standards and Control (NIBSC) standard). The methods were validated for linearity (correlation coefficient=0.99), range, accuracy, precision and robustness. Robustness was confirmed by considering three factors; mobile phase composition, column temperature and flow rate/age of mobile phase. Intermediate precision was confirmed on different equipments, different columns and on different days. The relative standard deviation (RSD) (<2% for RP-HPLC and <1% for UPLC, n=30) indicated a good precision. Retention time was found about 17 min and 2 min by HPLC and UPLC methods, respectively. Both methods are simple, highly sensitive, precise and accurate and have the potential of being useful for routine quality control. © 2012 Xi'an Jiaotong University. Production and hosting by Elsevier B.V. All rights reserved.


Rane S.S.,M. S. University of Baroda | Rane S.S.,Intas Biopharmaceuticals Ltd. | Ajameri A.,Intas Biopharmaceuticals Ltd. | Mody R.,Intas Biopharmaceuticals Ltd. | Padmaja P.,M. S. University of Baroda
Journal of Pharmaceutical Analysis | Year: 2012

Rapid and sensitive reverse phase high performance liquid chromatography (RPHPLC) and ultra performance liquid chromatography (UPLC) methods with UV detection for quantification of erythropoietin (EPO) in presence of human serum albumin (HSA) as a stabilizer in a pharmaceutical formulation of EPO have been developed and validated. Chromatography was performed with mobile phase containing 0.1% Trifluoroacetic acid (TFA) in MilliQ water and 0.1% TFA in acetonitrile with gradient program and a flow rate of 1.5 mL/min for HPLC and 0.35 mL/min for UPLC. Quantification was accomplished with internal reference standard (qualified using EP reference standard). The methods were validated for linearity (correlation coefficient=0.99), accuracy, precision and robustness. Robustness was confirmed by considering three factors; percentages of TFA in mobile phase, age of test sample and mobile phase and column temperature. Intermediate precision was confirmed by different analysts, different equipments and on different days. The relative standard deviation (RSD) value (<2%, n=30) indicated good precision of the developed method. The proposed RP-HPLC method had retention time less than 20 min while the developed UPLC method had retention time less than 4 min. Both the RP-HPLC and UPLC methods were simple, highly sensitive, precise and accurate, suggesting that the developed methods are useful for routine quality control. © 2012 Xi'an Jiaotong University. Production and hosting by Elsevier B.V. All rights reserved.


Mall P.,Intas Biopharmaceuticals Ltd | Mohanty B.K.,P.A. College | Tunga B.S.,Intas Biopharmaceuticals Ltd | Tunga R.,Intas Biopharmaceuticals Ltd
International Journal of Pharma and Bio Sciences | Year: 2011

Evolutionary Operation (EVOP) factorial design technique was sequentially used to optimize concentrations of various media ingredient such as MRS broth, nisin and milk in order to maximize nisin production using Lactococcus lactis (MTCC-440). Traditional method for optimization of media ingredient involves changing one variable at a time and keeping all other parameters constant. However, this method does not determine the interactive effects of different factors. EVOP factorial designing technique was applied consecutively and the results were analyzed statistically and next set of experiments were carried by getting the clue from the previous set of experiments till the effect of individual media components are less than the error limits. Streptococcus agalactiae (NCIM-2401) was used as an indicator strain for quantification of nisin by agar diffusion assay. Nisin yield increased when fermentation was carried out at 30°C at 100 rpm with final formulated media having mediaingredient concentrations MRS broth, milk and nisin 5.5 %, 0.7 % and 0.25 μg/mL respectively. Consequently, with successful implementation of EVOP factorial design technique Nisin production was increased from 206.1 μg/mL to 271.69 μg/mL, which was approximately 1.31 fold.


Mall P.,Intas Biopharmaceuticals Ltd | Kumar V.,Intas Biopharmaceuticals Ltd | Parikh V.,Intas Biopharmaceuticals Ltd | Dave D.,Intas Biopharmaceuticals Ltd | And 2 more authors.
International Journal of Pharma and Bio Sciences | Year: 2011

Aeromonas proteolytica (ATCC 15338) was grown at flask level and fermenter level in different concentrations of LB. LB at 4% was found to be optimum for maximum production of Aminopeptidase. At flask level, 30 oC and 180rpm was found to be optimum. In fermenter level, Aminopeptidase was successfully produced at 30 oC, 700rpm, pH 7.0 ± 0.05 and airflow of 0.5 LPM. Partial purification of the protein was achieved by ion exchange chromatography on DEAE sepharose. Aminopeptidase was eluted between 170mM and 230mM of NaCl concentration in a gradient elution process. Buffer exchange was done by gel filtration chromatography (Sephadex G25). In reverse phase high performance liquid chromatography (RP-HPLC), the retention time of standard and that of the partially purified Aminopeptidase was recorded at ~12min. Molecular weight and iso electric point of standard (Aminopeptidase from Sigma) and partially purified Aminopeptidase were found to be ~30kD and 3.5 respectively.


PubMed | Intas Biopharmaceuticals Ltd.
Type: Journal Article | Journal: PDA journal of pharmaceutical science and technology | Year: 2012

During storage of recombinant human parathyroid hormone (rhPTH) (amino acid residues 1-34) at 25 2 C, several impurities were obtained, which were detected by the tricine sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and reversed-phase high-performance liquid chromatography (RP-HPLC) methods. To characterize the impurities generated, forceful chemical oxidation and deamidation was done. The oxidized positions were characterized by cyanogen bromide (CNBr) cleavage followed by liquid chromatography/mass spectrometry (LCMS) and further confirmed through N-terminal sequencing. Three oxidized variants were observed: sulfoxide of Met8 and Met18 and a variant comprising sulfoxide forms of both the methionine residues. LCMS results confirmed the presence of deamidated (+1 Da) and succinimide (-17 Da) variants. The low molecular weight impurities observed by tricine SDS-PAGE was confirmed to be peptide fragments by N-terminal sequencing and LCMS, resulting from cleavage at the C-terminal of asparagine (Asn)16, Asn33, and Asp30. Studies showed that rhPTH (1-34) undergoes oxidation, deamidation, and peptide bond cleavage during storage at pH 4.0 in acetate buffer.Unlike currently licensed therapies to manage osteoporosis, parathyroid hormone (PTH) and its analogs represent a new class of anabolic agents, which act primarily to inhibit bone resorption and remodeling. The hormones recombinant form is a bioactive peptide, 1-34 residues, which is inherently very unstable. Prior understanding of the molecular degradation pathway will help in development of a process that will yield a better product with respect to its quality and stability. The current work focuses on detailed characterization of the product-related impurities generated during storage of recombinant human PTH. The study depicted the various routes through which the molecule can degrade during its shelf life. Through a combination of forced degradation and accelerated study, it was established that the impurities were generated owing to oxidation, deamidation, and peptide bond cleavage of/at various amino acid residues. Until this study, it was presumed that oxidation is the primary route of degradation in PTH and most of the published reports were on native (1-84) forms of the hormone. The present research confirms that the recombinant hormone (1-34) degraded not only because of oxidation but that deamidation and peptide bond cleavage are also prominent modes of degradation. Therefore, owing to the unstable nature of the molecule it is suggested that stringent conditions should be maintained during manufacturing to obtain a stable molecule with fewer impurities.

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