Pompano Beach, FL – August 11th, 2020 — BioStem Technologies, Inc. (OTC PINK: BSEM) a leading life sciences company specializing in the development and sale of perinatal tissue-based allografts for use in regenerative therapies, today announced that its subsidiary, Blue Tech Industries, Inc. (doing business as BioStem Life Sciences), has signed a Master Service Agreement with a new customer to manufacture the customer’s amniotic membrane platform for the next two years, in a deal estimated to be worth up to $2.4 million to BioStem. The agreement also allows the companies to initiate additional projects in the future. [Read more…]
Stemmatters is a Portuguese contract development and manufacturing (CDMO) organisation based in Barco, Guimarães. Originally a spin-off from University of Minho, it offers contract development and manufacturing services for cell-based advanced therapies, exosomes, blood-derived biologics, tissue products, biomaterials, and combination devices.
In the interview below, we explore Stemmatters history, services, manufacturing facilities, and future goals. Enjoy! [Read more…]
With a swell of R&D activity flowing into the development of cell and gene therapies over the past decade, a manufacturing shortage gripped the industry. This caused industry participants to express grave fears that the manufacturing shortage would threaten industry growth and lengthen time-to-market for these new types of living therapies.
While there remains a shortage of skilled workers, the manufacturing capacity available to the cell and gene therapy marketplace has turned a proverbial corner, entering an era of prolific growth.
Aggressive construction of cell and gene therapy manufacturing facilities is now being undertaken by biotech companies seeking their own production capabilities, as well as by Contract Development and Manufacturing Organizations (CDMOs) who plan to serve third-party clients. [Read more…]
ElevateBio, a newcomer to the cell and gene therapy sector, is taking a different approach than the competition. Founded only months ago in early 2019, the company plans to aggregate a portfolio of cell and gene therapy companies that will develop, manufacture and commercialize life-transforming medicines.
It has launched with an unusual business model, which is to be a hybrid CDMO for cell and gene therapy companies, as well as an investment holding company. It will accomplish this feat by offering “R&D and cGMP manufacturing facilities to be shared across several portfolio companies, each with a different disease focus.”
Key to ElevateBio’s plan is the construction of an R&D and cGMP manufacturing facility in Cambridge, MA, that it calls BaseCamp. The complex will act as a centralized research and manufacturing group to support a portfolio of promising cell and gene therapy companies, each which will have a different disease focus.
Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.
Cell Therapy Manufacturing CDMOs
While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing. [Read more…]