Abstract

Stem cell bioprocessing

Author(s): Erik Klaus

In order to advance the goal of employing stem cells for cell treatment, the Stem Cell Bioprocessing Group is concentrated on creating scalable cell growth technologies using a micro-carrier platform. Commercial cell production cannot be scaled up using conventional techniques for flask- and tray-based generation of anchorage-dependent stem cells.

The potential of stem cell research for tissue engineering-based therapeutics and clinical applications in regenerative medicine has been thoroughly recognised in recent years. Chung developed the first complete organ transplant in 2006 utilising adult stem cells and a clinical evaluation scaffold. Seven patients with myelomeningocele who received bladder transplants made possible by stem cell therapy saw significant improvements in their quality of life, marking a new milestone. Although the bladder is a fairly straightforward organ, the discovery shows the amazing advantages of the multidisciplinary approach of tissue engineering and regenerative medicine (TERM), which includes stem cell study and stem cell bioprocessing. Undoubtedly, the application of engineering principles and practises is required in the development of bioprocess technologies for the transfer of the current laboratory-based practise of stem cell tissue culture to the clinic as therapeutics in order to achieve control, reproducibility, automation, validation, and safety of the process and the product. Fundamental research (from embryonic biology to the ‘omics’ technologies and developments in immunology) and current industry experience (biologics), particularly on automation, quality assurance, and regulation, will need to contribute to the effective translation. It will be crucial to design, integrate, and implement various components on time; mistakes made in the past with regard to marketing, pricing, production, and advertising (such as when skin analogues were commercialised) shouldn’t be repeated.