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バイオマニュファクチャリング機能の戦略:フレキシブル、スケーラブルおよび効率的なバイオマニュファクチャリングシステムの開発

Biomanufacturing Capacity Strategies: Developing a Flexible, Scalable and lean Biomanufacturing system

発行 Insight Pharma Reports 商品コード 337544
出版日 ページ情報 英文 74 Pages
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バイオマニュファクチャリング機能の戦略:フレキシブル、スケーラブルおよび効率的なバイオマニュファクチャリングシステムの開発 Biomanufacturing Capacity Strategies: Developing a Flexible, Scalable and lean Biomanufacturing system
出版日: 2015年08月31日 ページ情報: 英文 74 Pages
概要

当レポートでは、現在の産業基準よりも反応性が高く動的なバイオマニュファクチャリングアプローチの必要性に注目し、バイオマニュファクチャリング開発の歴史と今後10年間の方向性、シングルユーズバイオマニュファクチャリング技術・動向の概要、リアクティブバイオマニュファクチャリングの重要性、エボラワクチン臨床開発・評価プロセスについての考察、および技術ソリューションからビジネス戦略にわたる特殊機能の強化アプローチなどについて詳細に分析しています。

エグゼクティブサマリー

第1部:イントロダクション・背景情報

第1章 調査フォーカス

第2章 バイオマニュファクチャリングの歴史

第3章 シングルユーズのバイオマニュファクチャリング

  • シングルユーズのバイオマニュファクチャリングの発明、歴史、および影響
  • 市場の現況および実行
  • シングルユーズ技術のメリット
  • 結論

第2部:バイオマニュファクチャリング機能の戦略、機会および課題

第4章 機能およびフレキシビリティを拡大する戦略

  • オフショアリング

第5章 機能に影響を及ぼす外部要因、課題、および機会

第6章 オペレーション上の優れた点およびコスト削減

第7章 バイオマニュファクチャリング産業・専門的職業の将来

第3部:バイオテクノロジー産業における課題のソリューションとしてのバイオマニュファクチャリング機能の革新

第8章 市場トレンド・予測がどのようにして生産パラダイムへ影響を及ぼすか

  • インタビュー
  • 調査結果
  • Insight Pharma Reportsによるバイオマニュファクチャリング機能の戦略に関する調査結果

参考資料

Cambridge Healthtech Instituteについて

図表

目次

The newly published Insight Pharma Reports, ‘Biomanufacturing Capacity Strategies: Developing a Flexible, Scalable, and Lean Biomanufacturing System Report’, focus on the need for a more reactive and dynamic biomanufacturing approach than is the current industry standard.

Biomanufacturing is common practice in the life sciences industry and has been continually developed and improved for the last two decades. However, as blockbuster drugs reach the end of their patents, treatment is evolving to become more patient-centric and personalized. The mapping of the human genome has allowed for sophisticated and effective new genetic markers and diagnostic methods to be developed, meaning that personalized medicine is becoming a reality. This has a direct impact on manufacturing, with long-term expected production paradigm shifts in the shape of near-patient manufacturing. Moreover, the rise in incidence of viral pandemics has driven a need for quick set-up, disposable, transportable biomanufacturing. This was a contributing factor to Tamiflu being first to market and will very likely be key in the race to stop the Ebola pandemic.

In addition to covering background information on biomanufacturing and capacity approaches, this report will highlight several technologies, methodologies, and business strategies that can be implemented to improve the capacity and flexibility of biomanufacturing.

Included in this Report:

  • Detailed the history of biomanufacturing development and the direction for the coming decade
  • Overview of single-use biomanufacturing techniques and trends, outlining the importance of reactive biomanufacturing
  • Insight into the Ebola vaccine clinical development, as well as the validation process.
  • Specific capacity-enhancing approaches ranging from technology solutions to business strategy
  • Examine the overarching industry pressures that are driving capacity needs, the subsequent regulatory compliance, and where the biggest efficiency and productivity savings can be realized.
  • Explore the scale-up of biomanufacturing processes to serve commercial scale production, which is currently a major limiting factor in the maturity of this field, and how commercialization of certain therapeutics and regenerative medicines is severely limited by the lack of progression here.
  • Ventures into the realm of lean thinking and continuous manufacturing methodologies and their application in the field of biomanufacturing with a secondary look at the potential of combining modular facilities with disposable biomanufacturing systems and the technical requirements and advances.
  • Details a considerable amount with regard to technology transfer and the specific issues relating to biomanufacturing, and outlines some solutions and new approaches to knowledge transfer
  • Takes a wider view of the context, importance, and impact of biomanufacturing and its capacity to provide a solution to several biotechnology industry challenges.
  • Provides insight into the field of personalized medicine, cell and gene therapies, and commercial-scale manufacturing vs. near-patient production and the predicted paradigm shift.
  • Interviews with:
    • Tony Hitchcock, Technical Director, Cobra Biologics
    • Jerold Martin, Sr. V.P. Global Scientific Affairs, Biopharmaceuticals, Pall Corporation
    • Arnaud Schmutz, General Manager, Sourcin
    • Nigel Smart, Managing Partner, Smart Consulting Group
    • Keith Thompson, CEO, Cell Therapy Catapult
  • Results Biomanufacturing Capacity Strategies Survey

Table of Contents

Executive Summary

PART I:

Introduction and Background Information

CHAPTER 1

  • Focus of the Report

CHAPTER 2

  • The History of Biomanufacturing

CHAPTER 3

  • Single-use biomanufacturing
    • The advent of single-use biomanufacturing, history, and impact
    • Current state of market and implementation
    • Advantages of single-use technologies:
      • Regulatory Challenges
      • Obsolete safety testing methods
    • Conclusion:
      • The importance of flexible and reactive biomanufacturing
      • Strong business case...but what of implementation and reality?

PART II:

Biomanufacturing Capacity Strategies, Opportunities, and Challenges

CHAPTER 4

  • Strategies to increase capacity and flexibility
    • Offshoring

CHAPTER 5

  • External Factors Affecting Capacity, Challenges, and Opportunities

CHAPTER 6

  • Operational Excellence and Cost Reduction

CHAPTER 7

  • The Future of the Biomanufacturing Industry and Profession

PART III:

Biomanufacturing Capacity Innovation as a Solution to Biotechnology Industry Challenges

CHAPTER 8

  • How Market Trends and Predictions Will Affect the Production Paradigm
  • Industry Interview Transcripts
    • Tony Hitchcock
    • Jerold Martin
    • Arnaud Schmutz
    • Nigel Smart
    • Keith Thompson
  • Survey Results
  • Results from Insight Pharma Reports Survey on Biomanufacturing Capacity Strategies
  • References

About Cambridge Healthtech Institute

TABLES

  • Table 2.1 Regulations in EU Member States regarding hES1 cell research
  • Table 5.1: Factors Influencing Capacity and Flexibility Needs

FIGURES

  • Figure 4.1: Levels of Increase in Biomanufacturing by 2020
  • Figure 4.2: Manufacturing Capacity Strategies Overview
  • Figure 4.3: Modular Facilities Implementation
  • Figure 4.4: Single-Use Technology Implementation
  • Figure 4.5: Outsourcing Implementation
  • Figure 4.6: Offshoring Implementation
  • Figure 5.1: Factors Driving Biomanufacturing Capacity Needs
  • Figure 5.2: Biomanufacturing challenges 2015-2020
  • Figure 8.1: BioPharma Strategy - New Paradigm
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