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

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



Published Date

1st Aug 2015



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Biomanufacturing Capacity Strategies - 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.
Biomanufacturing Capacity Strategies - Table of Contents
Executive Summary


Introduction and Background Information


Focus of the Report


The History of Biomanufacturing


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


The importance of flexible and reactive biomanufacturing

Strong business caseā€¦but what of implementation and reality?


Biomanufacturing Capacity Strategies, Opportunities, and Challenges


Strategies to increase capacity and flexibility



External Factors Affecting Capacity, Challenges, and Opportunities


Operational Excellence and Cost Reduction


The Future of the Biomanufacturing Industry and Profession


Biomanufacturing Capacity Innovation as a Solution to Biotechnology Industry Challenges


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
Biomanufacturing Capacity Strategies - Figures and Tables

Table 2.1 Regulations in EU Member States regarding hES1 cell research

Table 5.1: Factors Influencing Capacity and Flexibility Needs


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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