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

Executive Summary

Biomanufacturing Capacity Strategies: developing a flexible, scalable and lean biomanufacturing system has a 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 personalised. The mapping of the human genome has allowed for sophisticated and effective new genetic markers and diagnostic methods to be developed, meaning that personalised 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. Part I of this report includes chapters 2 and 3, highlighting background information relevant to the rest of the report. Chapter 2 will detail the history of biomanufacturing development and the direction for the coming decade, as well as the validation process. Chapter 3 will give a brief overview of single use biomanufacturing techniques and trends, outlining the importance of reactive biomanufacturing and insight into the Ebola vaccine clinical development.

Part II of the report includes chapters 4, 5, 6, 7 and 8, which will dig deeper into specific capacity enhancing approaches ranging from technology solutions through to business strategy. Here, the report will also examine the overarching industry pressures that are driving capacity needs, the subsequent regulatory compliance and where the biggest efficiency and productivity savings can be realised. Chapter 6 will 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 commercialisation of certain therapeutics and regenerative medicines is severely limited by the lack of progression here. Chapter 7 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. Experts interviewed for this section include: Jerold Martin, Arnaud Schmutz and Nigel Smart. Each of these interviewees discusses their research and how they are advancing the biomanufacturing field. Chapter 8, the final chapter in Part II of this report, details a considerable amount with regard to technology transfer and the specific issues relating to biomanufacturing. The less commonly addressed issue of knowledge transfer is a critical factor in successful replication and validation of biomanufacturing process, this chapter also outline some solutions and new approaches to knowledge transfer. Interviews from Tony Hitchcock and Keith Thompson will be featured in this part of the report.

Part III shifts slightly to take a wider view of the context, importance and impact of biomanufacturing and the capacity thereof as a solution to several Biotechnology industry challenges. Chapter 9 provides insight into the field of personalised medicine, cell and gene therapies and commercial scale manufacturing vs. neat patient production and the predicted paradigm shift.

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

List of Tables

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

List of 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