- Central European Biotechnology Portal
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Cell therapy commercialization – challenge accepted

Publish date: 2014-07-07

A recent progress made in the field of cell therapy was accompanied with a great promise for treatment of various diseases that nowadays are extremely hard to manage. However, after successful discoveries made in the laboratories all over the world, it is time to face obstacles that hamper its commercialization.

Tags: stem cells , commercialization , cell therapy

Cell therapy (regenerative medicine) is based on the replacement of damaged or malfunctioning cells by healthy ones. The discovery of induced pluripotent stem cells unveiled that it is possible to restore stem cell properties in differentiated cells by means of overexpression of particular transcription factors. Hence, it is now possible to obtain patient-specific cells that can be potentially used for regenerative medicine without such issues as immunological rejection.

The critical aspect that need to be considered in order to make cell therapy a successful way of treating patients is a commercialization process. A transfer of the therapy from discovery to the market and associated challenges were the scope of a panel titled “Targeting the End Game: Keys to Reaching Commercial Viability by Establishing the Right GMP Processes for Cell Therapy Clinical Trials from Processing to Delivery to the Patient” that took place during  2014 BIO International Convention in San Diego. During the session, it was emphasized that process integrity, product quality and regulatory issues, which are not so critical during first phases of therapy development, are of great importance during the clinical trials. It was also underlined that the whole procedure of commercialization should be thoroughly considered at the early beginning as changes in a later stages of the project are significantly harder to perform.

Good manufacture practice (GMP) for Cell therapies, starting from laboratory research and ending in commercial production, is associated with influential obstacles. The panelists concluded that cell washing and concentration, which should eventually result in homogenous cell populations, are the most challenging processes. However, expansion of cells, their accurate characterization and cell banking are also not free from impediments.

There exist numerous disorders waiting for efficient ways of treatment just to mention diabetes, spinal cord injuries or Parkinson’s disease. The solution could be cell therapy. Nonetheless, taking into account all challenges associated with its commercialization, we should be aware that the way to its successful application as a treatment method is still very long and bumpy. However, if these challenges would be accepted and well-understood, a majority of them might be overcome step by step.


The BIO International Convention 2014 in San Diego was hosted by the Biotechnology Industry Organization (BIO), which encompasses more than 1,100 biotechnology companies, academic institutions and other related organizations across the world. It is the largest global biotechnological event offering networking and partnering opportunities, and focusing on the major trends in the industry.


Maciej Smolarz


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