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PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating CMC product development bridging strategies for biotherapeutics and vaccines.

It illustrates how Quality by Design (QbD) can be a powerful enabler of acceleration, fostering deeper understanding of what is critical, what level of CMC risk is acceptable, and hence what elements of product development can be streamlined.

More than 60 authors have contributed to this influential text emphasizing the importance of QbD to product development and commercialization. Several case studies covering biotherapeutics and vaccines are shared by several major companies and well-recognized academic institutions. These case studies illustrate that QbD is a key strategic approach to decide what should be prioritized, enabling both fast product, process, and analytical development, ensuring product safety and efficacy; and phase-appropriate control strategy and comparability, focused on patient needs.

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In addition, this book demonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment and focus on non-redundant activities, fostering tailored innovation. Examples of how the use of modelling can be a powerful asset to ensure the streamlined execution of experimental activities (e.g., process, stability, and analytical space) are included.

\r\n

All of these aspects are covered in the four comprehensive sections of the book, which are organized under the following topics:

  • Part I- Product Understanding \r\n
  • Part II- Process Understanding and Modeling\r\n
  • Part III- Analytical Strategy and Modeling\r\n
  • Part IV- Platform Knowledge

Available to download. Prior to purchase please view the download instructions and Terms of Usage
\r\nFormat: PDF (1 file 59.7 MB)

\n"},{"sequence":"2","tabName":"Table of Contents","text":"

Table of Contents:

Click here to download >>>Detailed Table of Contents

Part 1: Introduction

Part II: Product Understanding

Section 1: Critical Quality Attributes and Ranges

Section 2: Formulation Development

Section 3: Stability Modeling

Section 4: Comparability

Part III: Process Understanding and Modeling

Section 5: Process Understanding and Modeling

Part IV: Analytical Strategy and Modeling

Section 6: Analytical Strategy and Modeling

Part V: Platform Knowledge

Section 7: Platform Knowledge

Part VI: Conclusions

\n"}],"shortDescription":"PDA's book, Quality by Design — An Indispensable Approach to \r\nAccelerateBiopharmaceutical Product Development, is an important \r\ncontribution to the ongoing dialogue for accelerating CMC product development \r\nbridging strategies for biotherapeutics and vaccines. It illustrates how Quality \r\nby Design (QbD) can be a powerful enabler of acceleration, fostering deeper \r\nunderstanding of what is critical, what level of CMC risk is acceptable, and \r\nhence what elements of product development can be streamlined. This book also \r\ndemonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment \r\nand focus on non-redundant activities, fostering tailored \r\ninnovation.\r\n","freeTechReport":"false","subProducts":[{"productId":"6054","name":"Quality by Design","displayName":"Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)","imageUrl":"https://store.pda.org/ProductImages/QbD_cover.jpg.ashx?width=150&height=225&bgcolor=white","prices":[{"price":"240.0000","name":"Government","memberTypeID":"6"},{"price":"240.0000","name":"Member","memberTypeID":"2"},{"price":"299.0000","name":"Non-Member","memberTypeID":"1"}],"by":null,"editedBy":"Cristiana Campa, Mohammed Amin Khan","datePublished":"Mar 2021","isbn":"9781945584220","productCode":"48005","format":"PDF Single user","inStock":"true","formatType":"Digital","numOfPages":"514","tabs":[{"sequence":"1","tabName":"Description","text":"

PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating CMC product development bridging strategies for biotherapeutics and vaccines.

It illustrates how Quality by Design (QbD) can be a powerful enabler of acceleration, fostering deeper understanding of what is critical, what level of CMC risk is acceptable, and hence what elements of product development can be streamlined.

More than 60 authors have contributed to this influential text emphasizing the importance of QbD to product development and commercialization. Several case studies covering biotherapeutics and vaccines are shared by several major companies and well-recognized academic institutions. These case studies illustrate that QbD is a key strategic approach to decide what should be prioritized, enabling both fast product, process, and analytical development, ensuring product safety and efficacy; and phase-appropriate control strategy and comparability, focused on patient needs.

\r\n

In addition, this book demonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment and focus on non-redundant activities, fostering tailored innovation. Examples of how the use of modelling can be a powerful asset to ensure the streamlined execution of experimental activities (e.g., process, stability, and analytical space) are included.

\r\n

All of these aspects are covered in the four comprehensive sections of the book, which are organized under the following topics:

  • Part I- Product Understanding \r\n
  • Part II- Process Understanding and Modeling\r\n
  • Part III- Analytical Strategy and Modeling\r\n
  • Part IV- Platform Knowledge

Available to download. Prior to purchase please view the download instructions and Terms of Usage
\r\nFormat: PDF (1 file 59.7 MB)

\n"},{"sequence":"2","tabName":"Table of Contents","text":"

Table of Contents:

Click here to download >>>Detailed Table of Contents

Part 1: Introduction

Part II: Product Understanding

Section 1: Critical Quality Attributes and Ranges

Section 2: Formulation Development

Section 3: Stability Modeling

Section 4: Comparability

Part III: Process Understanding and Modeling

Section 5: Process Understanding and Modeling

Part IV: Analytical Strategy and Modeling

Section 6: Analytical Strategy and Modeling

Part V: Platform Knowledge

Section 7: Platform Knowledge

Part VI: Conclusions

\n"}],"shortDescription":"PDA's book, Quality by Design — An Indispensable Approach to \r\nAccelerateBiopharmaceutical Product Development, is an important \r\ncontribution to the ongoing dialogue for accelerating CMC product development \r\nbridging strategies for biotherapeutics and vaccines. It illustrates how Quality \r\nby Design (QbD) can be a powerful enabler of acceleration, fostering deeper \r\nunderstanding of what is critical, what level of CMC risk is acceptable, and \r\nhence what elements of product development can be streamlined. This book also \r\ndemonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment \r\nand focus on non-redundant activities, fostering tailored \r\ninnovation.\r\n","freeTechReport":"false","yourPrice":"299.0000"}],"yourPrice":null,"lowestPrice":"299.0000","lowestPriceFormat":"PDF Single user"}">
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质量源于设计——加速生物制药产品开发的不可或缺的方法(单用户数字版本)

编辑:Cristiana Campa, Mohammed Amin Khan

PDF单用户
州长价格:240.00美元 会员价格:240.00美元 非会员价格:299.00美元
  • 描述
  • 表的内容

PDA的书,通过设计提高质量——加速生物制药产品开发的一个不可或缺的途径由行业专家Cristiana Campa(葛兰素史克疫苗技术研发)和M. Amin Khan(葛兰素史克疫苗研发)编辑,是促进生物治疗药物和疫苗CMC产品开发桥梁战略持续对话的重要贡献。

它说明了质量通过设计(QbD)是如何成为一个强大的加速推手,促进对什么是关键的更深入的理解,什么水平的CMC风险是可接受的,因此产品开发的哪些元素可以流线化。

超过60位作者贡献了这篇有影响力的文章,强调QbD对产品开发和商业化的重要性。几家大公司和知名学术机构分享了涉及生物疗法和疫苗的几个案例研究。这些案例研究表明,QbD是一个关键的战略方法,决定什么应该优先,实现快速产品、过程和分析开发,确保产品安全和有效性;以及阶段适宜的控制策略和可比性,以患者需求为重点。

此外,本书还演示了先验知识如何有助于qbd驱动的风险评估,并关注非冗余活动,促进量身定制的创新。举例说明如何使用建模来确保实验活动(例如,流程、稳定性和分析空间)的流线型执行。

所有这些方面都涵盖在书的四个全面的部分,这四个部分被组织在以下主题下:

  • 第一部分-产品理解
  • 第二部分-过程理解和建模
  • 第三部分:分析策略和建模
  • 第四部分:平台知识

可以下载。购买前请查看下载说明的用法
格式:PDF(1档案59.7 MB)

表的内容:

点击这里下载>>>详细目录

第1部分:介绍

第二部分:产品理解

第1节:关键质量属性和范围

第二节:配方开发

第3节:稳定性建模

第四节:可比性

第三部分:过程理解和建模

第5部分:过程理解和建模

第四部分:分析策略与建模

第6部分:分析策略和建模

第五部分:平台知识

第七部分:平台知识

第六部分:结论

下载说明