Cell therapy weekly: New manufacturing site for cell culture media announced
This week: Amicus and Catalent (both NJ, USA) collaboration aims to boost gene therapy marketing, a novel stem cell technique may speed up stroke recovery and stem cells promoted to self-organize into layers
The news highlights:
Construction of a new manufacturing site for cell culture media announced
Amicus and Catalent collaboration aims to boost marketing of gene therapies
Novel stem cell stimulation technique may improve stroke recovery time
Stem cells self-organize into ordered layers
Fujifilm Irvine Scientific (CA, USA), an international leader in the field of cell culture media development, has announced plans to open a third manufacturing site in Tilburg (Netherlands). The new site will deal with the manufacturing of animal component-free, dry powder media, liquid media, downstream bioprocessing liquids and water for injection (WFI). The move aims to help accelerate the production and marketing of cell and gene therapies.
Yutaka Yamaguchi, CEO of FUJIFILM Irvine Scientific, commented: “The biopharmaceutical market is growing at a high rate, and cell therapies are moving into clinical trials and commercialization at fast pace. The company's current capacity is >1,000,000 kg/year of dry powder , but it is imperative that we exceed production requirements of customers worldwide, as well as meet our European customer demand for regional support. Building a third, world-class cGMP manufacturing facility to serve as a European hub will enable us to better provide customers with rapid, reliable supply of products."
Amicus therapeutics (NJ, USA) and Paragon Gene Therapy – of Catalent Biologics (NJ, USA) – have announced their partnership aiming to support the development and manufacturing of preclinical lysosomal disorder gene therapies, currently being developed at Penn State University (PA, USA). The collaboration hopes to leverage Amicus’ pipeline of gene therapies and Paragon’s biotherapeutics development capabilities.
John Crowley, Chairman and Chief Executive Officer of Amicus commented: “As we continue to articulate our near- and long-term Amicus gene therapy manufacturing strategy, our collaboration with Paragon Bioservices is a significant next step in securing clinical scale-up and supply for our Pompe gene therapy, as well as our other active preclinical programs.” Crowley continued: “Leveraging our internal expertise and process development in combination with Paragon’s expertise and platform capabilities we hope to expedite the process of moving our preclinical gene therapy programs into the clinic as quickly as possible.”
Researchers at Emory University (GA, USA) have used a nasally administered protein to stimulate neural stem cells injected into mice brains following stroke. This novel cell stimulation technique –optochemogenetics – caused the stem cells to develop more connections, grow healthier and allow the mice to recover from stroke quicker, compared with mice who received unstimulated stem cells. If this research is extended into humans, stroke patients’ quality of life could be significantly improved.
In the study, the authors concluded: “Neural network reconnection is critical for repairing damaged brain, strategies that promote this repair are expected to improve functional outcomes. This study pioneers in the generation and application of an optochemogenetics approach in stem cell transplantation therapy after stroke for optimal neural repair and functional recovery… The non-invasive repeated CTZ stimulation of transplanted cells is feasible for clinical applications. The synergetic effects of the combinatorial cell therapy may have significant impacts on regenerative approach for treatments of CNS injuries.”
Researchers at the EPFL Institute of Bioengineering (Lausanne, Switzerland) have mimicked aspects of embryo formation in vitro. The team used a microfluidic device – a chip that tightly regulates fluid passage via small channels – to expose human embryonic stem cells, in culture, to a gradient of morphogens, mimicking real-life conditions of early embryonic development. The result was that the cells organized into discreet groups according to the concentrations of morphogen they were exposed to, akin to how embryonic cells act during development.
Matthias Lütolf, lead researcher and Professor at EPFL commented: “One of our long-term goals is to engineer organs for transplantation. We are still far from growing functional organs in a dish; but recent progress in stem cell biology and bioengineering make me optimistic that this can become a reality. The key is to better understand how cells themselves build tissues and organs in the embryo”.
For more weekly cell therapy news, read previous editions of the cell therapy weekly.