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Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine
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0 KommentareExpands GEN-1 Program Collaboration to Add Clinical and Commercial Batches of Investigational Vaccine
LAWRENCEVILLE, N.J. and HAINAN, China, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, today announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.
Poly Pharm is experienced with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the World Health Organization (WHO).
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Madame Fang, chief executive officer of Hainan Poly Pharm said, “Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience. Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsion’s OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in highly cost-effective manufacturing of nucleic acid based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA vaccine technology platform is a promising platform as it may address global vaccine storage and distribution needs. We are pleased that Celsion has recognized Poly Pharm’s skills and dependability, especially with difficult-to-manufacture products, and we are looking forward to helping address the global COVID-19 pandemic.”
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