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项与 Recipharm Pharmaservices Pvt Ltd. 相关的药物

Verdiperstat

靶点

MPO

作用机制

MPO抑制剂

在研机构

Biohaven Pharmaceuticals, Inc.

原研机构

AstraZeneca PLC

在研适应症

肌萎缩侧索硬化

非在研适应症

多系统萎缩 [+4]

最高研发阶段临床2/3期

首次获批国家/地区-

首次获批日期-

100 项与 Recipharm Pharmaservices Pvt Ltd. 相关的临床结果

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0 项与 Recipharm Pharmaservices Pvt Ltd. 相关的专利（医药）

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项与 Recipharm Pharmaservices Pvt Ltd. 相关的文献（医药）

2024-08-01·Annales Pharmaceutiques Françaises

Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form

Article

作者: Gowrishankar, BS ; Ajaykumar, KB ; Puttaraju, R ; Chaithanya, Mathud Shivamurthaiah ; Ajaykumar, Kodigenahalli Balarajagupta ; Puttaraju, Ranganatha ; Gowrishankar, Bychapur Siddaiah ; Savanth, Varsha D ; Naveenaradhya, C ; Prashanthi, DeviReddy ; Chaithanya, M S ; Naveenaradhya, Channabasavaiah ; Veerapur, Veeresh Prabhakar

OBJECTIVETo develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.MATERIAL AND METHODRP-HPLC method was developed using Luna (C₁₈) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.RESULTSThe retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q₂ R₁ guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R² of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.CONCLUSIONThe developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.

Integrated approach for purification of complex fusion protein produced in mammalian expression system

作者: Das, Anindita ; Sundaramoorthy, Nandakumar ; Ingole, Charan ; Sadarangani, Vineet ; Paranandi, Madhava

Within the biopharmaceuticals portfolio, monoclonal antibodies and fusion proteins encompass the largest global market share and have a remarkable efficacy in treatment of several major diseases.Established platform purification processes are available for monoclonal antibodies and due to their similarity, these processes can be used, thus decreasing the development duration.The quality attributes to be controlled for the mAb modalities are well characterized and significant information is available in public domain.Fusion proteins on the other hand have distinctive structures since they are engineered by combining two different protein domains preferably by peptide linkers.This linking of two protein domains out of their natural form, lead to generation of complex impurities which are less understood as compared to mAb modalities.If the fusion protein does not have an Fc portion then there is an addnl. challenge of capturing the protein from cell culture harvest stage.Consequently, the risk of complex, difficult to remove HCPs in the product increases.This gives rise to an urgent need for innovation using novel technol. for purifying fusion proteins with unique structures thus enabling control of the complex difficult-to-remove impurities.In this presentation an integrated purification strategy for a complex non-mAb fusion protein expressed in mammalian expression systems is described, with primary focus on issues encountered during development, scale up and technol. transfer.In this study using a combination of resin and single-use technol. with non-conventional mode of chromatog., an integrated process was developed to control HCPs, high and low mol. weight species , viruses to acceptable levels.This study also details the strategy to address potential challenges related to complex protein associated HCPs and low mol. weight species by performing in depth characterization of the impurities and subsequently design the solution for controlling these impurities.

Host cell proteome dynamics: Identification, Quantitation by Mass Spectrometry

作者: Sundaramoorthy, Nandakumar

Host cell proteins are an inevitable byproduct of fermentation-based biomanufg. and are considered as critical quality attributes (CQA).The biggest concern of not removing HCP (Host cell protein) from a therapeutic protein preparation is the potential for HCPs to elicit severe immunogenic responses in patients, particularly with high-dose drugs like recombinant therapeutic antibodies.HCP profile can be affected by numerous upstream process decisions such as cell culture duration, feeding strategies, culture temperature or by production up-scale for commercialization.Along with three routes by which HCPs can challenge purification steps: Product association through strong attractive interactions with mAbs products under Protein-A loading concentrations, variable expression during extended cell culture, or co-elution with mAbs on polishing steps.Enzyme-linked immunosorbent assays (ELISA) are still gold standard method as it provide the global HCP amount as an output without individual identification of the HCPs present and its coverage is incomplete.This limitation directly relates to immunogenic risk and antibody degradation which raises urgent need for alternative methods.Mass spectrometry has become the most promising and powerful tool to unravel individual HCP identification and provide unbiased relative quantitation.This presentation will be built on multiple case studies discussing the outcomes of the host cell proteome population and its dynamics during cell culture supernatant at different growth phases of fed-batch cell culture to purificationAlong with it, we are summarizing the correlation between proteases and their implications on antibody quality and stability.Using this as the basis for the case study, the capabilities of this novel approaches from sample preparation to data collection for HCP identification and relative quantitation were evaluated in the context of high-speed and sensitive methods for the identification of low abundant HCPs, protein-associated HCPs and host cell proteases including their localization.

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100 项与 Recipharm Pharmaservices Pvt Ltd. 相关的转化医学

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