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The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally
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Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation
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May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated toxicities
Nearly $10 Billion Pours Into Cell & Gene Therapy Contract Manufacturing Infrastructure
Currently, the cell and gene therapy (CGT) field is on track for a serious capacity shortage. In particular, there is a significant shortage of manufacturing capacity at the commercial scale. Although nearly 90% of cell and gene therapy developers would prefer to use contract manufacturing organizations (CMOs), relevant CMO capacity is not yet available. [Read more…]
Charles River Snags Gene Therapy CDMO Vigene Biosciences for $292.5M
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…]
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