January 1, 2011 (Vol. 31, No. 1)

Ultimate Goal of Initiatives Is to Facilitate Translation of Innovation into Regenerative Therapies

Earlier this year Roslin Cells and Lonza signed a stem cell media development deal the firms hope will play a key role in the drive to translate scientific innovation in the stem cells field into clinically applied regenerative therapies.

The agreement is centered on the development of clinical-grade media for applications including the maintenance and expansion of pluripotent stem cells and their differentiation into predefined cell and tissue types.

The Lonza and Roslin Cells team will be perfectly placed to tackle the scientific, technical, and regulatory aspects of developing GMP-grade media suitable for the large-scale manufacture of stem cell-based products, according to Aidan Courtney, CEO of Roslin Cells.

“Roslin Cells was established specifically to move the field of stem cell research into the clinical arena, initially through the development of GMP pluripotent stem cell lines. Lonza has expertise in the development and scale-up of cell culture processes, including animal-free, fully characterized cGMP culture media. Their knowledge and expertise in these fields and the negotiation of relevant regulatory pathways will perfectly complement Roslin’s capabilities centered on development of the actual stem cell lines and their application in a clinical environment.”

Courtney points out that while stem cell culture media is currently available for academic use, much of it is not geared to GMP standards. In fact, he suggests, “there is still a long way to go in the development of chemically defined, certified media that will allow clinical production, maintenance, and expansion of stem cells and their differentiated progeny, reproducibly, and, equally importantly, cost effectively.”

The fact that pluripotent stem cells are, by their very nature, capable of differentiating into completely different types of cells will require a new mind-set in terms of developing culture media. Maintaining stem cell lines used for therapeutics will require media and growth factors capable of keeping them undifferentiated while maintaining pluripotency. A whole range of media will then be needed to effect their expansion and reproducible differentiation into predefined cell types.

“At the research or even early clinical phases of development, cell production is often carried out at the laboratory scale,” continues Phil Vanek, Ph.D., head of innovation and business development at Lonza. “However, the biggest challenge facing the industry relates to later-stage clinical development and commercial production of stem cell therapeutics.

“Manufacturing will be on a scale that is essentially thousands-fold larger. A combined package including the cells, culture platform, media, and growth factors will need to be wholly scalable, cost-effective, and generate exactly the same types of cells every time. Critically, this package must include the means to verify that the cells you end up with retain their stated characteristics.”

The collaboration by Roslin and Lonza will, thus, be multifaceted. “We are interested in all types of pluripotent stem cells, which in itself throws up many challenges,” Courtney adds.

cGMP manufacturing of cellular therapies requires careful consideration of cell type, media quality, culture platforms, and quality systems.

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