Vakzine Projekt Management GmbH and ProBioGen AG enter process development and manufacturing collaboration for Soluferon®
Under the terms of the agreement, GBF will provide funding over the next 18 months to ProBioGen for the process development and manufacturing of Soluferon®. VPM will manage the project. The collaboration encompasses the entire process development from cell culture and medium adaptation to the establishment of the manufacturing process, plus providing materials for toxicological, pre-clinical and clinical testing in Phases I & II, using the continuous production technology of ProBioGen at its state-of-the-art cGMP facilities in Berlin.
Soluferon® is a genetically modified Interferon-ß with 9 amino acid exchanges which lead to improved physical and biological properties compared to natural human Interferon-ß. It is expected that these improved properties will offer patients less side-effects and higher therapeutic efficacy. VPM is organising preclinical and clinical trials and intends to outlicense out the product to potential partners at an adequate stage of development.
"This collaboration with Vakzine Projekt Management underpins our ability to provide innovative, economical and easily up-scalable manufacturing processes in the highly competitive arena of biopharmaceutical manufacturing." said Michael Schlenk, CEO of ProBioGen.
"It has been a highly rewarding experience to have found a partner who is similar to our organisation in the ability to combine innovation with flexibility, pragmatism and dedication. We are convinced that Soluferon® will show superior clinical efficacy and will be a very attractive candidate for pharmaceutical partners in the future." said Dr. Albrecht Läufer, CEO of VPM.
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