Bioreactor Technologies

Rationale

In recent years, the potential of stem cell research for tissue engineering-based therapies and regenerative medicine clinical applications has become well established based on the broadening interest of not only the scientific community, but also the clinical arena, biomedical and biotechnology industry, and general public at large. With the first entire organ transplant using adult stem cells and a scaffold being clinically evaluated in 2006, a new milestone was achieved with seven myelomeningocele patients receiving stem cell-derived bladder transplants resulting to substantial improvements in their quality of life. Unquestionably, the development of bioprocess technologies for the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic as therapeutics necessitates the application of engineering principles and practices to achieve robust control, reproducibility, automation, validation, and safety of the process and the product [1-9].

The success of stem cell biomanufacturing relies on robust and reproducible culture conditions and processes. The biomanufacturing design principles include: a) process components, b) process requirements, and c) process functionality. A combination of generic, off-the-shelf, and personalized manufacturing paradigms must be considered as no single technology satisfies all requirements. The process components consist of the cell source and type, the elucidation of appropriate signals required for cellular development, in addition to scaffold and bioreactor design and implementation. Process requirements address practical considerations of bioprocessing satisfying good manufacturing practices such as, quality assurance, bioprocess monitoring control and automation, in addition to product transportation. Finally, the process components and process requirements need to ensure the end-product's functionality, integration and longevity to name but a few vital factors included in the process functionality.

The creation of a "Bioreactor Technologies" thematic group within TERMIS will aim to address pertinent issues associated with the bioprocessing of stem & somatic cells including a) bioreactor design, b) cell/tissue format, b) monitoring technologies, c) process modularity and integration, d) scale-up, e) computational modeling, f) automation practices, g) regulatory requirements, etc. The activities of this thematic group will generate critical scientific information and discussion amongst leaders in the field resulting in the timely development, integration, and execution of various components, in order to ultimately ensure the successful advance of bioreactor technologies to clinical applications and commercial products. Membership for the thematic group will be actively solicited and is envisioned to be comprised of academic researchers, clinicians, industry partners and regulatory agencies with vested interests in the application of bioreactor technologies for tissue engineering and regenerative medicine.

Proposed Activities

A number of different activities associated with the annual continental meetings and World Congress, as well as throughout the year will be planned and coordinated by the officers and members of this thematic group. Of particular important to this thematic group will be the engagement of industry.

  • Workshops: Held immediately before the start of the annual meetings, continental representatives could organize a half-day workshop focusing on a specific research, translational or clinical theme related to the design, analysis and implementation of bioreactor technologies and related enabling technologies.
  • Symposia: During the annual and World Congress meetings, sessions or symposia would be organized on the general theme of bioreactor technologies as they relate to tissue engineering and regenerative medicine, or depending upon interest and availability, a series of sessions focused on specific topics within the field of bioreactor research and applications could be planned.
  • Poster session awards: A sub-set of posters self-identified by the authors as related to bioreactor technologies (during the abstract submission process) could be evaluated by a panel of judges comprised of the officers and members of the thematic group. The award would be sponsored by an external entity (preferably an industrial partner who manufactures bioreactors or related technologies).
  • International Standards Roundtable: During the World Congress meeting, we aim to organize a roundtable that will engage academics, industrialists, clinicians, and regulators in order to produce international standards that could be used as "best-practice" guidelines by the community.

Outside of the annual meetings, a series of activities would be organized with different frequencies and utilizing different communication media, most of which would be web-based and electronically recorded and saved in a digital archive. These activities would be intended to largely support ongoing discussion among members of the thematic group and may require some administrative, technical and/or logistical support in order to be maintained consistently and professionally.

  • Webinars: Leaders in the field will be asked to give a brief "live" or pre-recorded lecture (i.e. 15-30 minutes) that will be electronically recorded and saved in a password-protected format such that TERMIS members would either have restricted or preferred access.
  • LinkedIn updates: A LinkedIn group would be created that would be open to all interested TERMIS members and potentially even non-TERMIS members, which could serve to broaden participation and recruit membership to the society and thematic group. Relevant stories of interest would be posted on a monthly basis and limited to no more than 5 articles of interest per month. The LinkedIn group would also include a message board which would allow members to post items for discussion and comments. Membership and postings to the site would be monitored for quality control purposes.

 

Proposed Office Holders

Chair: Prof. Athanasios Mantalaris (Department of Chemical Engineering, Imperial College London)
Vice Chair: Prof. Masahiro Kino-Oka (Department of Biotechnology, Osaka University)
Secretary: Prof. Todd McDevitt (Department of Biomedical Engineering, Georgia Institute of Technology)

Scientific Board

North America

  1. Prof. Taby Ahsan (Tulane University; tahsan@tulane.edu)
  2. Prof. Terry Papoutsakis (Delaware Biotechnology Institute, University of Delaware, papoutsakis@dbi.udel.edu)
  3. Prof. Thanassis Sambanis (Georgia Tech; athanassios.sambanis@chbe.gatech.edu)
  4. Prof. Peter Zandstra (University of Toronto; peter.zandstra@utoronto.ca)

Asia/Pacific

  1. Dr. Steve Oh (A-STAR, Singapore; steve_oh@bti.a-star.edu.sg)
  2. Prof. Yasuyaki Sakai (University of Tokyo; sakaiyas@iis.u-tokyo.ac.jp)
  3. Prof. Xue-Hu Ma (Dalian R&D Centre for Stem Cell and Tissue Engineering, department of Chemical Engineering, Dalian University of Technology, Dalian, China; xuehuma@dlut.edu.cn)

Europe

  1. David Williams (University of Loughborough, UK; D.J.Williams2@lboro.ac.uk)
  2. Joaquim Sampaio Cabral (Instituto Superior Técnico, Portugal; joaquim.cabral@ist.utl.pt)
  3. Julian Chaudhuri (University of Bath, UK; j.b.chaudhuri@bath.ac.uk)

 

References

[1] D.C. Kirouac, P.W. Zandstra, The Systematic Production of Cells for Cell Therapies, Cell Stem Cell, 3 (2008) 369-381. 
[2] M. Lim, H. Ye, N. Panoskaltsis, E.M. Drakakis, X.C. Yue, A.E.G. Cass, A. Radomska, A. Mantalaris, Intelligent bioprocessing for haemotopoietic cell cultures using monitoring and design of experiments, Biotechnology Advances, 25 (2007) 353-368. 
[3] Y. Liu, P. Hourd, A. Chandra, D.J. Williams, Human cell culture process capability: a comparison of manual and automated production, Journal of Tissue Engineering and Regenerative Medicine, 4 (2010) 45-54. 
[4] C. Mason, M. Hoare, Regenerative medicine bioprocessing: Building a conceptual framework based on early studies, Tissue Engineering, 13 (2007) 301-311. 
[5] R.M. Nerem, Regenerative medicine: the emergence of an industry, Journal of the Royal Society Interface, 7 (2010) S771-S775. 
[6] M.R. Placzek, I.M. Chung, H.M. Macedo, S. Ismail, T.M. Blanco, M. Lim, J.M. Cha, I. Fauzi, Y. Kang, D.C.L. Yeo, C.Y.J. Ma, J.M. Polak, N. Panoskaltsis, A. Mantalaris, Stem cell bioprocessing: fundamentals and principles, Journal of the Royal Society Interface, 6 (2009) 209-232. 
[7] E.A. Rayment, D.J. Williams, Concise Review: Mind the Gap: Challenges in Characterizing and Quantifying Cell- and Tissue-Based Therapies for Clinical Translation, Stem Cells, 28 (2010) 996-1004. 
[8] J.A. Rowley, Developing Cell Therapy Biomanufacturing Processes, Chemical Engineering Progress, 106 (2010) 50-55. 
[9] H. Thomson, Bioprocessing of embryonic stem cells for drug discovery, Trends in Biotechnology, 25 (2007) 224-230.