On October 29, 2021 HAMLET Pharma reported that The clinical trial program in bladder cancer is proceeding according to plan, using Alpha1H secured from previous production rounds (Press release, HAMLET Pharma, OCT 29, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharma-secures-alpha1h-production-for-continued-clinical-trials [SID1234594655]). Larger amounts of Alpha1H will be needed moving forward, as the clinical trial program is expanding to involve larger patient numbers .
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As previously announced, Hamlet Pharma is collaborating with Rechon Life Science for the production and formulation of the drug candidate Alpha1H. Rechon Life Science AB is a manufacturer approved for pharmaceutical supply worldwide, including the US. Together with Hamlet Pharma, Rechon has now successfully established large scale Alpha1H production technology. Production is carried out in accordance with Good Manufacturing Practice (GMP) and Alpha1H, packaged for clinical use, will be distributed to the clinical trial site.
"Scaling up the production of of Alpha1H is essential for the growth of Hamlet Pharma and for future clinical trials" says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.
‘’Securing a robust production of our drug candidate is an important milestone for the company", says Mats Persson, CEO of Hamlet Pharma Ltd.