Cultured meat refers to lab-grown meat created using cell culture techniques. It is produced by growing master cells collected from cattle, chicken, pigs, fish, and lamb, as well as other types of livestock and seafood. In addition to meat and seafood production, cultured meat techniques can be used to ethically manufacture other types of animal products, such as leather, fur, milk, and hen-free egg whites, for example. Cultured meat is ethically produced, because livestock is not used within the manufacturing processes beyond collecting the initial cells for culture. [Read more…]
I Peace’s Cell Manufacturing Facility “Peace Engine Kyoto” now registered as U.S. FDA Drug Establishment
Palo Alto, California, January 25, 2022 – I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up, announced that its cell manufacturing facility is now listed on the FDA “Drug Establishments Current Registration Site.” The registration recognizes I Peace’s cell manufacturing facility as suitable for drug manufacturing, based on detailed information submitted to the FDA. Comprehensive details of clinical grade iPSC manufacturing are registered in the FDA Drug Master File (DMF). [Read more…]
Accelerate the Development of Off-the-Shelf Therapies by Attending the Allogeneic Cell Therapies Summit
Join 400+ experts from across pharma, biotech, and academia who will be attending the 4th Allogeneic Cell Therapies Summit in Boston on May 9-12, 2022.
Over the past decade, CAR-T cell therapies have revolutionized the field of cell therapy, demonstrating clear curative potential with autologous approaches. Now, the field is looking to take these treatments a step further, by delivering next generation products that are cheaper, safer, and more efficacious. [Read more…]
Four RMAT Designations in 18 Days Signal Accelerating FDA Support for Regenerative Medicine
While there has been a consistent stream of RMAT approvals since the designation was created in 2017, with 60 publicly announced to date, the number of approvals in the first few days in 2022 are noteworthy. Specifically, from January 1 to January 18, 2022, four companies publicly announced RMAT designations, as described below.
An RMAT designation is an award from the U.S. FDA that allows for faster, more streamlined approvals of regenerative medicine products within the United States, such as cell and gene therapies, tissue engineering products, and combination products. RMAT designations make innovative products eligible for quicker development and review of a marketing application. [Read more…]
How the Cord Blood and Tissue Market is Changing
The global cord blood and tissue banking market is consolidating, driven by the emergence of holding companies and aggressive M&A activity. This is creating risks for cord blood market participants, as well as new opportunities.
Serious threats to the industry include:
- Low rates of stored cord blood utilization
- Utilization of bone marrow and peripheral blood stem cells as alternative sources of stem cells for HSCT
- Growing prevalence of haploidentical transplantation
- Expensive transplant procedures, ranging from $200-300K
- Difficulty educating Obstetricians about the future value of cellular therapies
- Low rates of market penetration
- Low rates of cord blood awareness among expectant parents
- « Previous Page
- 1
- …
- 152
- 153
- 154
- 155
- 156
- …
- 336
- Next Page »