Nanomi BV and InnoCore Technologies BV today announced the successful completion of a feasibility study performed by BioConnection, regarding the cGMP manufacturing of their advanced controlled release microsphere formulations based on the SynBiosys biodegradable polymeric drug delivery system and MonosphereTM monodisperse microsphere manufacturing technology. This study followed InnoCore’s and Nanomi’s announcement earlier this year to jointly offer their respective SynBiosys and Monosphere technologies to the market as a powerful platform technology for the creation of microsphere depot formulations for the sustained delivery of biotherapeutics.
Currently parties are negotiating an agreement where BioConnection will take care of clinical manufacturing of controlled release microsphere formulations of biotherapeutic proteins that are under development at Nanomi and InnoCore for a European customer. BioConnection, besides clinical manufacturing, would also provide additional CMC development services, including manufacturing process scale-up to commercial scale.
"BioConnection gives us access to state-of-the-art cGMP manufacturing facilities for parenterals," said Gert Veldhuis, CEO of Nanomi. "Their ability to provide clinical trial material together with a clear perspective towards commercial scale-up would fill up a crucial part of our value proposition to our pharmaceutical clients," added Rob Steendam, CTO of InnoCore."
"We are pleased with the positive outcome of the study", said Alexander Willemse, CEO of BioConnection. "The SynBiosys and Monosphere platforms offer us a beautiful technical challenge where we can apply and enhance our knowledge of biopharmaceutical product development while giving Nanomi and InnoCore access to global manufacturing via our state-of-the-art production facilities."