This week in cell therapy: New funding will expedite development of nanoscale manufacturing technology, Roche collaboration will target antigen-presenting cells and Center of Excellence will provide customers with latest Terumo technology.
The news highlights:
Korean regulator raids four cell therapy developers
US$95 million will expedite expansion of cell therapy manufacturing
Roche partnership will develop immuno-oncology therapies
Collaboration will see development of US Center of Excellence
The Korean regulator, the Ministry of Food and Drug Safety, recently conducted “urgent inspections” of four manufacturers of cell therapy, as reported in the Korea Biomedical Review. Industry sources speaking to the Review said that Kolon Life Science, Tego Science, Bio Solution and Medipost (all South Korea) were raided on Monday, indicating concerns over a possible change in cell source or donor.
Speaking to the Review, Kolon Life Science said, “The company is producing therapies with the cells given from a cell bank. We did not change the cell donor or add a new donor. The FDA also recognized that our cells came from the single donor.”
Tego Science also commented that company has never changed a donor since obtaining approval, emphasizing that the company’s technology had the biggest merit that the cell source did not change.
Berkeley Lights, Inc. (CA, USA) has completed US$95million worth of funding to expand their nanoscale technology for the acceleration of drug discovery, and development and manufacture of cell therapy. The Beacon® platform is a closed nanofluidic device including an epifluorescent microscope for monitoring of automated assays.
“This investment from new and past investors is a testament to the significant strides that BLI has already made in transforming the future of drug discovery and development with our digital cell biology platform….as we continue to strengthen our technology’s global presence, we will be focusing on adding platform capabilities that will, ultimately, make personalized cell therapeutics accessible to all,” said Eric Hobbs, CEO, Berkeley Lights.
SQZ Biotechnologies (MA, USA) and Roche (Basel, Switzerland) are to expand their collaboration to develop and commercialize immunotherapy leads for oncology based on peripheral blood mononuclear cells (PBMCs) to also investigate antigen presenting cells (APCs)-based therapies. These aim to leverage the native immune functions to encourage CD8 T cell responses to target tumors inaccessible by previously developed cell-based cancer immunotherapies.
Howard Bernstein, Chief Scientific Officer of SQZ, commented “By creating a PBMC APC platform, this collaboration allows for a SQZ APC product engine that could potentially generate products with more potent immunologic responses through a simplified, more efficient manufacturing process.”
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Cognate BioServices (TN, USA) and Terumo BCT (CO, USA) have announced a collaboration whereby Cognate will incorporate current and future Terumo technology into their innovation labs, serving as a Center of Excellence for closed system manufacturing. The center will also serve as a test site for new and developing technology.
J. Kelly Ganjei, CEO, Cognate BioServices, commented: “Terumo BCT’s reputation for bringing automation to the cell therapy industry for apheresis and cell processing technologies is outstanding and we are excited to be a center of excellence for both our prospective and current clients in the US and abroad. One of our goals as a CDMO is to provide the experience and direction for our clients which help to improve and expedite processes in all phases. We are also pleased to expand on our existing relationship with Terumo BCT to share our innovation team’s development and manufacturing feedback from clients on current and new technologies.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.