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industry focus.

Going beyond the life sciences – scaling up production to meet

global demand By David Haddow, Operations Director, Altrika Ltd

Notwithstanding largely agreed definitions in the regenerative medicine sector[1]

, the

distinctions are becoming increasingly blurred due to the interdisciplinary techniques being employed such as cellularised matrices, cell-based gene therapies, small molecule activator therapies etc. The technical advances made in the sector since the infamous Time Magazine article of May 2000 (Figure 1) have been enormous.

Figure 1. Being a tissue engineer was predicted to be the number one job by Time Magazine on 22nd May 2000. Gene programming was second on the list.

That article defined the sector in terms of tissue engineering, now viewed as a subset of regenerative medicine – one that focuses on the engineering of tissues often in conjunction with support scaffolds or matrices. In order to meet the global demand for regenerative medicine solutions, the focus on the engineering principles will be paramount, not only in influencing biological characteristics, but, perhaps more critically, in being able to physically deliver the technology on a relevant scale.

The demand for regenerative medicine solutions is real, driven by shifting patient demographics, and described by the concept of ‘Boomsday’, or the ‘Silver Tsunami’, referred to by numerous commentators[2]

percentage of the US population that is over the age of 65 is projected to increase from 13% to 19% from 2010 to 2030[3]

in the US in 2030 than there are today. In the UK the percentage of the population aged over 60 will rise from 22% in 2010 to 29% in 2030[4]

(an increase in the elderly population of 7 million).With this change in David Haddow

demographics, markets in indications common among older populations will grow – these include heart disease, stroke, pulmonary diseases, diabetes and cancer. The direct cost of all heart diseases in the US is projected to increase from $273 billion on 2010 to $818 billion in 2030. These looming costs create incentives and challenges for the regenerative medicine industry, as the sector that has the most potential to impact on long term health and costs. Confidence that science can deliver the therapies is high – can the engineers deliver the scale-up in production required to meet global demand?

The ability to manipulate and reprogramme cells and DNA, control gene expression and engineer proteins is resulting in increased translation of exciting therapies from laboratory to clinical practice. Whilst the clinical potential for regenerative medicine is clear, the real value is likely to be assessed by business and consumers in terms of commercial applications, impact on the marketplace and financial success.

. The . That is 32 million more elderly people

Cell-based regenerative therapies will require huge amounts of cells for a therapeutic dose. The numerous clinical trials in regenerative medicine that are currently recruiting are beginning to inform the dose requirements. In many cases multiple applications will be needed. It is estimated that treatments for heart disease will require a billion cells per patient. There are 5 million patients in the US who could benefit from a treatment like this. Cell production on the peta (1015

) scale is beyond the

scope of current culture methods, and the regenerative medicine industry will require innovative production schemes to meet demand. The solutions are likely to be driven by engineering rather than biological solutions.

“ When it comes to the future, there are three kinds of people: those who let it happen, those who make it happen and those who wonder what happened.” John M. Richardson, Jr.


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