Palo Alto, California, May 25, 2021 – I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology “induced pluripotent stem cells (iPSCs)” received a third-party certification as US FDA cGMP compliant for its manufacturing facility “Peace Engine Kyoto,” in Kyoto Japan. Peace Engine Kyoto is owned and managed by its sole subsidiary I Peace, Co. Ltd. The facility was awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products. [Read more…]
Organicell To Present Results Of Zofin™ Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting
Miami, FL (May 25th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that the Company will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021. [Read more…]
The Rise of Exosomes as a Novel Class of Therapeutics
Today, exosomes are increasingly being investigated as a novel class of therapeutics that could explain the functions of many types of traditional cell therapies. To explain this trend, we contacted an esteemed exosome researcher, Dr. Ramon Coronado Schmilinski. Dr. Coronado Schmilinski was the previous Executive Director at Lester Smith Medical Research Institute and is the current VP Regulatory Affairs and Technology Transfer at Signature Biologics.
In this interview, we discuss how he started working with exosomes while looking for mechanisms used by MSCs to exert their therapeutic effects. We discuss the scientific importance of exosomes, their therapeutic and diagnostic applications, and how exosomes are being used within encapsulation and delivery systems.
Read on to learn how these extracellular vesicles could transform the future of modern medicine as we know it.
5 Strategies To Stay on Top of a Changing Cell Therapy Industry
Author: Jonathan Wofford, General Manager of WellSky’s Biotherapies Division
As operations for cell and gene therapy programs become more demanding and supply chain management becomes more complex, your program may face various challenges adapting to these changes. For example, increasing manufacturing and procedure volumes in combination with new and changing protocols will require the use of more automated, flexible and efficient processes. Tightening regulations will require greater documentation and process control. As cell and gene therapies continue to grow in clinical application, payers, study sponsors, and other agencies will require more data and reporting. [Read more…]
FDA Regulation of Cellular and Tissue-Based Products with Dr. Riam Shammaa
In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products.
While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of cell therapy, gene therapy, and tissue engineering products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.
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