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30

2023-03

Materials for the Administration of Human Genetic Resources

Materials for the Administration of Human Genetic Resources

2023-03-30

He Yousheng

27

2023-03

Is there a bubble in China’s cell and gene therapy industry?

At the beginning of 2023, following a high-profile yet now decidedly less vibrant JP Morgan conference in the United States, biotech companies that had endured three harsh winters under capital scarcity not only failed to see a thaw in funding but instead faced a wave of successive layoffs, company closures, and asset sales: Aristea in the large-molecule space shut down, while Goldfinch and Xenikos initiated liquidation proceedings; in the cell and gene therapy sector, Editas and Century carried out workforce reductions, and Rubius closed its doors.

2023-03-27

He Yousheng

27

2023-03

Now that Funo Biotech is also entering the cell and gene CDMO space, could it be following the same path as the antibody industry?

Following the spin-off of CMC and manufacturing teams from antibody biopharmaceutical companies to establish independent CDMO firms, there is now a growing trend among cell and gene therapy R&D companies to carve out CGT CDMOs as well. For instance, JiaYin Bio, an AAV drug developer, established CoJourney Biotech in 2022 as an AAV CDMO service provider, while FunoGene Biotech, a oncolytic virus drug developer, recently founded FRASERNA to offer a one-stop CRDMO platform for viral vector and nucleic acid therapeutics—covering everything from concept development through IND filing to commercialization. Since its founding in 2019, JiaYin Bio has been focused on the R&D of AAV viral vector–based gene therapies.

2023-03-27

He Yousheng

27

2023-03

The EBC Expo is a showcase for the bioindustry.

Yesterday, I attended the 2023 Yimao Biotechnology Industry Conference and Exhibition together with my colleagues. On the first day of the event, my observations in Hall C—primarily dedicated to instruments, equipment, and consumables—revealed the following: the upstream segment was dominated by fermentation tanks and bioreactors, while the downstream segment featured purification equipment such as chromatography columns, liquid-handling chromatography systems, and ATF tangential-flow filtration systems. General laboratory equipment included temperature-controlled instruments, liquid-handling workstations, ultrapure water systems, and pipette-assembly/sealing machines. As for reagents and consumables, the main categories were culture media, packing materials, filters, and culture flasks. Notably, most of the custom-designed booths were occupied by domestic brands, whereas several well-known foreign brands—such as Sartorius and Thermo Fisher—did not have any exhibition space at all. In contrast, leading Chinese instrument and equipment companies had all set up prominently designed, custom-built booths, including JinYi Shengshi, Biolab, Saiqiao Bio, Zhongboruikang, and Hanbang Tech.

2023-03-27

He Yousheng

22

2023-03

ChemoMetec Fully Automated Cell Counter | More Accurate Counts, Higher Standards!

The cell therapy and gene therapy industries are experiencing rapid growth, and to ensure the quality of their final products, every process and step relies on precise cell counting. ChemoMetec, a Danish company, is a global leader in the manufacture of cell-counting and analysis equipment, specializing in the development and production of high-precision instruments that deliver accurate data to thousands of customers across the biotechnology, pharmaceutical, and academic sectors. Its NucleoCounter® series—comprising the NC-200™, NC-250™, and NC-3000™ models—employs advanced cell-image analysis and fluorescence staining technologies to determine cell count and viability, thereby providing maximum assurance of precision, stability, and consistency in cell-counting processes. The company is currently successfully listed on the NASDAQ.

2023-03-22

He Yousheng

14

2023-03

Good News | We are delighted to announce that Hycells has officially become a service agent for Suzhou Yudeyang Biotechnology Co., Ltd.!

Suzhou Yudeyang Biotechnology Co., Ltd., established in January 2020, is a company dedicated to providing biosafety testing services for the biopharmaceutical industry. The company has now built a comprehensive platform for MCB/WCB/EOPC/UPB cell bank testing and virus clearance validation, equipped with GMP and GLP quality systems that comply with both Chinese and U.S. regulatory requirements. With proven experience in successfully submitting regulatory applications in both China and the United States, Yudeyang is fully capable of meeting the IND and BLA regulatory submission requirements of biopharmaceutical clients. In China, aside from WuXi AppTec Testing in Suzhou, which offers end-to-end biosafety testing that satisfies dual-regulatory submission requirements, Yudeyang is the second testing platform able to meet these regulatory standards.

2023-03-14

He Yousheng
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