標(biāo)題: Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien [打印本頁] 作者: 實(shí)體 時(shí)間: 2025-3-21 20:03
書目名稱Challenges in Protein Product Development影響因子(影響力)
書目名稱Challenges in Protein Product Development影響因子(影響力)學(xué)科排名
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書目名稱Challenges in Protein Product Development網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Challenges in Protein Product Development被引頻次
書目名稱Challenges in Protein Product Development被引頻次學(xué)科排名
書目名稱Challenges in Protein Product Development年度引用
書目名稱Challenges in Protein Product Development年度引用學(xué)科排名
書目名稱Challenges in Protein Product Development讀者反饋
書目名稱Challenges in Protein Product Development讀者反饋學(xué)科排名
作者: choroid 時(shí)間: 2025-3-21 20:54
The third stage and fetal adaptationts can relate to concentration, type of formulation, but also process- or product-related degradants or contaminants. Solution viscosity is of utmost importance for manufacturing as well as administration of biologics at higher concentration. Finally, aggregates and particles can arise as a result o作者: 踉蹌 時(shí)間: 2025-3-22 03:53
Aspects of monitoring in normal labourracterization are discussed in detail and practical recommendation is given. Different common techniques to measure viscosity are described including dependencies on protein concentration, temperature, and shear stress. Structural characterization of highly concentrated protein formulations requires作者: Prognosis 時(shí)間: 2025-3-22 07:59 作者: Ceramic 時(shí)間: 2025-3-22 12:16 作者: hangdog 時(shí)間: 2025-3-22 15:01
Charles Yuen Yung Loh,N. S. Niranjan are microbial challenge test, liquid tracer leak test, vacuum decay leak test, electrical conductivity leak test, tracer gas leak test, and headspace gas analyzer. Finally, the development, qualification, and validation of a method to be used are discussed. Each CCI test method has its advantages a作者: hangdog 時(shí)間: 2025-3-22 17:57
Ahmed A. Kamel,John V. Breakwellare discussed in detail as well as analytical techniques suited to investigate the impact on the properties of the primary packaging containers. The combination of the knowledge about the underlying root cause and the respective analytical tools to characterize the vial internal surfaces will help b作者: 與野獸博斗者 時(shí)間: 2025-3-23 00:41 作者: CHYME 時(shí)間: 2025-3-23 05:21 作者: ELATE 時(shí)間: 2025-3-23 08:13
Solubility, Opalescence, and Particulate Matterts can relate to concentration, type of formulation, but also process- or product-related degradants or contaminants. Solution viscosity is of utmost importance for manufacturing as well as administration of biologics at higher concentration. Finally, aggregates and particles can arise as a result o作者: FLIC 時(shí)間: 2025-3-23 10:17
Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulationsracterization are discussed in detail and practical recommendation is given. Different common techniques to measure viscosity are described including dependencies on protein concentration, temperature, and shear stress. Structural characterization of highly concentrated protein formulations requires作者: 亂砍 時(shí)間: 2025-3-23 16:04
Practical Considerations for High Concentration Protein Formulationsuct. If potential candidates with impeding viscosity values are not identified early in development, subsequent mitigation efforts to reduce viscosity likely pivot from a protein engineering approach to changes in formulation.作者: 陶器 時(shí)間: 2025-3-23 20:05 作者: 委屈 時(shí)間: 2025-3-23 22:28
Container Closure Integrity Testing of Primary Containers for Parenteral Products are microbial challenge test, liquid tracer leak test, vacuum decay leak test, electrical conductivity leak test, tracer gas leak test, and headspace gas analyzer. Finally, the development, qualification, and validation of a method to be used are discussed. Each CCI test method has its advantages a作者: 束以馬具 時(shí)間: 2025-3-24 02:24
Chemical Durability of Glass—Delaminationare discussed in detail as well as analytical techniques suited to investigate the impact on the properties of the primary packaging containers. The combination of the knowledge about the underlying root cause and the respective analytical tools to characterize the vial internal surfaces will help b作者: 共同確定為確 時(shí)間: 2025-3-24 09:24
2210-7371 tration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal o978-3-030-08052-5978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X 作者: 我就不公正 時(shí)間: 2025-3-24 13:08 作者: Nonthreatening 時(shí)間: 2025-3-24 16:00 作者: CHYME 時(shí)間: 2025-3-24 22:14 作者: 圓錐體 時(shí)間: 2025-3-25 01:14
Randomized trial of fetal monitoringdose required for efficacy and patient-preferred self-administration through subcutaneous injection, which is oftentimes limited by dosing volume. Development of high-concentration protein products, however, has been associated with two major challenges—high solution viscosity and enhanced aggregati作者: 用肘 時(shí)間: 2025-3-25 03:36
The third stage and fetal adaptationng dosage form (liquid, dried), color (coloration of solution, color of cake), cake appearance (in case of a lyophilisate), opalescence, or turbidity, and—in some cases—even visible particles. “Maximum solubility” is a parameter that has been previously evaluated for proteins. But given the nature o作者: Corral 時(shí)間: 2025-3-25 08:31 作者: 認(rèn)為 時(shí)間: 2025-3-25 15:07
Aspects of monitoring in normal labourgh concentration protein formulations have an increased tendency for high solution viscosity, physical stability sensitivities (aggregation/particulation), and non-Newtonian solution behavior (shear thinning) due to high shear rates. Process unit operations can be negatively impacted by these factor作者: 邊緣 時(shí)間: 2025-3-25 19:37
J. P. Kraehenbuhl,C. Bron,B. Sordateraction between the drug product formulation and the primary packaging components may also impact adequate delivery of the product to the patient. Therefore, primary packaging development should be fully integrated into parenteral drug product development. This book chapter describes the basic func作者: 易受刺激 時(shí)間: 2025-3-25 23:42 作者: Galactogogue 時(shí)間: 2025-3-26 02:04 作者: 江湖騙子 時(shí)間: 2025-3-26 06:15
The Stemness of Perinatal Stem Cells,eutics in combination with particular usability needs. Introductory Sect.?. reflects on the growing requirements on drug delivery devices for biologics in connection with new indications and user groups. Section?. discusses the boundary conditions, physical basics and technical requirements. Section作者: LAVA 時(shí)間: 2025-3-26 11:30 作者: hauteur 時(shí)間: 2025-3-26 16:22 作者: pessimism 時(shí)間: 2025-3-26 19:07 作者: 小溪 時(shí)間: 2025-3-26 22:27
Challenges in Protein Product Development978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X 作者: optic-nerve 時(shí)間: 2025-3-27 03:50
Nicholas W. Warne,Hanns-Christian MahlerDiscusses the challenges faced in biotechnology dosage form development.Provides practical and applied guidance in many areas including stability, microbiology and manufacturing, as well as case studi作者: 小爭(zhēng)吵 時(shí)間: 2025-3-27 08:44
AAPS Advances in the Pharmaceutical Sciences Serieshttp://image.papertrans.cn/c/image/223486.jpg作者: 侵蝕 時(shí)間: 2025-3-27 12:22
https://doi.org/10.1007/978-3-319-90603-4ADCs; Mabs; biologics; formulation; lyophilization; therapeutic proteins; HC Protein formulations; containe作者: Aromatic 時(shí)間: 2025-3-27 14:59 作者: 來自于 時(shí)間: 2025-3-27 21:06 作者: 認(rèn)為 時(shí)間: 2025-3-28 01:54
Polysorbate Degradation and Qualityins against interfacial stress. Structural heterogeneity, presence of degradants and other impurities, and tendency for degradation are interrelated features found in commercial PSs with a direct impact on their functional properties in biopharmaceutical products. These pose a challenge for the anal作者: Minutes 時(shí)間: 2025-3-28 05:58 作者: locus-ceruleus 時(shí)間: 2025-3-28 09:55
Introduction to High-Concentration Proteinsdose required for efficacy and patient-preferred self-administration through subcutaneous injection, which is oftentimes limited by dosing volume. Development of high-concentration protein products, however, has been associated with two major challenges—high solution viscosity and enhanced aggregati作者: Amylase 時(shí)間: 2025-3-28 10:54
Solubility, Opalescence, and Particulate Matterng dosage form (liquid, dried), color (coloration of solution, color of cake), cake appearance (in case of a lyophilisate), opalescence, or turbidity, and—in some cases—even visible particles. “Maximum solubility” is a parameter that has been previously evaluated for proteins. But given the nature o作者: 節(jié)約 時(shí)間: 2025-3-28 17:12
Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulationsion of predictive tools used during early development, specific challenges for analytical methods, and extended characterization of rheological and structural properties. The application of predictive tools during clinical lead selection and early-stage development helps to assess whether a selected作者: lobster 時(shí)間: 2025-3-28 19:22
Practical Considerations for High Concentration Protein Formulationsgh concentration protein formulations have an increased tendency for high solution viscosity, physical stability sensitivities (aggregation/particulation), and non-Newtonian solution behavior (shear thinning) due to high shear rates. Process unit operations can be negatively impacted by these factor作者: freight 時(shí)間: 2025-3-29 02:57 作者: 集合 時(shí)間: 2025-3-29 03:36
Development of Prefilled Syringe Combination Products for Biologicsther combination products offer patients the convenience of at-home self-administration. This can result in considerable cost savings compared to dosing in a clinical setting. PFS systems improve patient compliance and dosing accuracy, reduce overfill cost and waste, and can reduce sharps injuries (作者: 不可思議 時(shí)間: 2025-3-29 08:01 作者: 叫喊 時(shí)間: 2025-3-29 13:32
C Mini-pumpseutics in combination with particular usability needs. Introductory Sect.?. reflects on the growing requirements on drug delivery devices for biologics in connection with new indications and user groups. Section?. discusses the boundary conditions, physical basics and technical requirements. Section作者: 記憶 時(shí)間: 2025-3-29 16:15
Container Closure Integrity Testing of Primary Containers for Parenteral Productsntent inside. Ensuring the CCI of a parenteral product package is essential during the entire lifecycle of a product. The chapter first reviews the U.S. FDA regulatory requirements on CCI. Regulations for several regulatory authorities outside the USA are also presented for comparison. From these re作者: ineffectual 時(shí)間: 2025-3-29 20:16 作者: carotid-bruit 時(shí)間: 2025-3-30 03:57
Foggingestricted to ion leaching or corrosion effects but also impacting adsorption phenomena. The formulation can creep up the walls forming a thin liquid layer on the inside of the containers. This layer is getting visible as product residues on the vial walls after a lyophilization process. This mechani作者: 節(jié)省 時(shí)間: 2025-3-30 06:38 作者: placebo 時(shí)間: 2025-3-30 09:44
Randomized trial of fetal monitoringelopment of high-concentration protein products, however, has been associated with two major challenges—high solution viscosity and enhanced aggregation tendency. These challenges and the relevant strategies to overcome them are discussed herein, and future directions in the development of high-concentration products are proposed.作者: 按等級(jí) 時(shí)間: 2025-3-30 13:43 作者: debacle 時(shí)間: 2025-3-30 17:26 作者: arthroscopy 時(shí)間: 2025-3-30 22:02
Foggingayer on the inside of the containers. This layer is getting visible as product residues on the vial walls after a lyophilization process. This mechanism is known under the term of “fogging”. This chapter describes the underlying root causes and provides measures to avoid the issue.
