GMP workshop of Apextide officially started operation

发布时间：

2022-07-19

On July 18th, Hangzhou Apextide Bio-medical Technology Co., Ltd. reached another historical milestone as the GMP pilot production line located in Hangzhou Heida Pharmaceutical Valley Phase IV was officially put into operation.
The GMP pilot production line supports the company's oligonucleotide and peptide processes from R&D to pilot scale-up transfer. Serving as the intermediate hub between R&D and scale-up production, the line provides R&D data under GMP conditions for verification and confirmation, ensuring protection for subsequent scale-up production.
Additionally, it can produce products under GMP conditions. As a crucial link in transferring R&D results to production, this GMP workshop incorporates intelligent manufacturing concepts in its design, enhancing automation and safety investments to deliver higher quality products faster and support our customers' drug research and development.
This GMP production line spans 3,000 square meters, covering upstream and downstream production of oligonucleotides and peptides, as well as GMP analysis and testing. To meet internal development and customer needs, the line has heavily invested in advanced equipment such as Cytiva's OligoPilot, ÄKTA Process, Uniflux 30; Novasep's preparation system from France; Okawara thin film evaporator from Japan; and several imported high-resolution and secondary mass spectrometers to support process development and product release.

Mr. Andy Hou, General Manager of Apextide, stated that despite many challenges during the construction of the GMP production line, the team’s relentless efforts and full support from partners enabled the line to be put into production as scheduled.
Mr. Thomas Tong, Chairman of the Board of Directors of the Sinopep Group, congratulated Apextide on the efficient completion of the GMP production line. He noted that the development of oligonucleotide drugs has great market potential and represents the future trend, expressing hope that Apextide will seize this opportunity, be bold and enterprising, respond rapidly to the market, and efficiently serve customers.

Apextide successfully completed the GMP inspection by the FDA

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