Delving into the Latest Updates on Catalent Indiana LLC with Synapse

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关联

1

项与 Catalent Indiana LLC 相关的药物

Odronextamab

靶点

CD20 x CD3

作用机制

CD20抑制剂 [+3]

在研机构

再鼎医药（上海）有限公司 [+2]

原研机构

Regeneron Pharmaceuticals, Inc.

在研适应症

复发性弥漫性大B细胞淋巴瘤 [+12]

非在研适应症

高级别B细胞淋巴瘤

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2024-08-22

38

项与 Catalent Indiana LLC 相关的临床试验

CTR20242056

/ Recruiting临床3期

一项在中度至重度活动性克罗恩病受试者中评价Tulisokibart的有效性和安全性的III期、随机、双盲、安慰剂对照研究

研究1：根据第12周和第52周时达到临床缓解以及达到内镜应答的受试者比例，评价MK-7240与安慰剂相比的有效性。评价MK-7240的安全性和耐受性。研究2：根据第12周时达到临床缓解以及达到内镜应答的受试者比例，评价MK-7240与安慰剂相比的有效性。评价MK-7240的安全性和耐受性。

开始日期2024-10-08

申办/合作机构

默沙东研发（中国）有限公司

[+2]

CTR20242248

/ Recruiting临床3期

一项在嗜酸性粒细胞增多综合征（HES）患者中评价Benralizumab的有效性和安全性的多中心、随机、双盲、平行组、安慰剂对照、24周、III期研究（包含开放性扩展期）

评价Benralizumab对嗜酸性粒细胞增多综合征（HES）患者的有效性和安全性

开始日期2024-09-02

申办/合作机构

AstraZeneca AB

[+2]

CTR20241912

/ Recruiting临床4期

拉那利尤单抗（达泽优）和艾替班特（飞泽优®）在遗传性血管性水肿患者中的真实世界疗效和安全性：一项中国观察性研究

在真实世界的临床实践中接受至少一剂拉那利尤单抗或艾替班特的中国患者中，评价拉那利尤单抗和艾替班特的疗效和安全性。

开始日期2024-07-20

申办/合作机构

百深生物科技（上海）有限公司

[+3]

100 项与 Catalent Indiana LLC 相关的临床结果

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0 项与 Catalent Indiana LLC 相关的专利（医药）

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7

项与 Catalent Indiana LLC 相关的文献（医药）

Evaluation of eshmuno chromatography resins within a platform approach for the purification of trastuzumab

作者: Beard, Spencer ; Roberts, Tony ; Dhanasekharan, Kumar ; Stone, Todd ; Richey, Carl W.

Within a platform approach for purification of monoclonal antibodies, Cook Pharmica periodically evaluates new technologies which may be used within our array of tools.Chromatog. resins with increased binding capacities and resolution are highly desirable.In this case study, Eshmuno A was used to capture trastuzmab at a load challenge of 50 g IgG per L of resin.A screening DOE was then performed to assess the design space for Eshmuno CPX as a polishing step.A gradient elution was then applied to optimize the resolution with the cation exchange column, at a load challenge of 80 g IgG per L of resin.Finally, Eshmuno Q anion exchange was incorporated as a 2^nd polishing step at a load challenge of 150 g per L of resin.The purification process was demonstrated in clearance of process impurities including HCP, aggregate and Protein A.An overall yield greater than 80% was obtained from the pilot scale.An alternative 2-column purification process is also discussed and compared with the 3-column process.Both purification processes were modelled at the 2500 L bioreactor scale.

Pilot scale experiments to improve chromatography column packing procedures

作者: Richey, Carl ; Asplund, Patrick ; Bangla, Venkata ; Williams, Drew ; Roberts, Anthony

Large scale liquid chromatog. is the dominant purification technique used in the production of recombinant proteins.The quality of the column packing is a key parameter and its integrity impacts the purification performance.A ten cm diameter Index column (GE Healthcare) was packed with three different types of resin and three packing methods were executed for each resin.After each pack, the column was integrity tested by the Height Equivalent of Theor. Plate method (HETP).The integrity test results showed that in most cases, packing by axial compression resulted in an increased number of theor. plates.HETP integrity testing was also performed at varied linear flow rates for each column pack.A decreased flow rate was correlated with increased number of theor. plates.Consistent methodol. using the same residence time on the column is recommended for comparison of column integrity test results with similar column scales (diameter and bed heights) between projects.

Clarification platform evaluation and optimization

作者: Humbard, Kevin ; Wagner, Mark ; Dhanasekharan, Kumar ; Chefer, Kate ; Wang, Bingqing

Recent progressions in cell line development, media design, and process optimization have shown significant improvements to the cell culture production process and monoclonal antibody productionCorrespondingly, the increased product titer and cell densities also pose a challenge on cell removal and harvest clarification.This study was designed to evaluate different methods of clarification of a CHO cell culture harvest in terms of capacity, product recovery, product quality, and economic efficiency.Different clarification processes were tested using a single pool of cell culture harvest from a proprietary fed-batch process.The different methodologies tested include centrifugation, two-stage depth filtration, a combination of centrifugation with single stage depth filtration, and a combination of flocculation with single stage depth filtration.The maximum capacity of each clarification method was measured by P-max determinationAny change in total product amount, turbidity, lactate dehydrogenase (LDH), and host cell proteins (HCPs) were evaluated before and after each clarification step to compare process efficiency.Up to 50^difference in turbidity and 20^difference in HCPs was observed between different methods of clarification.LDH levels were similar between methods, indicating no change in amount of cell lysis between different methods.Product quality attributes were also monitored to evaluate any impact caused by the different methods.An economic anal. was done based on the information obtained from the experiments and pricing data from vendor to determine if a change to the current platform was warranted.Results from the evaluation helped to further characterize the cell culture harvest platform process to accommodate variable requirements of mammalian cell culture processes, particularly those yielding high cell densities and product titers.

100 项与 Catalent Indiana LLC 相关的药物交易

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100 项与 Catalent Indiana LLC 相关的转化医学

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