June 29, 2021, Wilmington, MA — Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has completed the previously announced acquisition of Vigene Biosciences, Inc. for $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes additional payments of up to $57.5 million, contingent on future performance. [Read more…]
Cell and Gene Therapy (CGT) Manufacturing Boom Roars Along
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…]
I Peace’s cell manufacturing facility “Peace Engine Kyoto” receives third-party certification as US cGMP compliant: the facility now meets the standard for both the US and Japanese markets
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…]
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.
- « Previous Page
- 1
- …
- 37
- 38
- 39
- 40
- 41
- …
- 60
- Next Page »