- SyVento BioTech has received Manufacturer/Importer Authorisation (MIA), enabling GMP-compliant production and import of sterile and biological investigational medicinal products.
- It is the first company in Poland authorised to manufacture and release clinical trial products based on mRNA and lipid nanoparticles (LNPs) entirely in-house.
SyVento BioTech has achieved a major breakthrough in Poland’s pharmaceutical manufacturing landscape by securing the Manufacturer/Importer Authorisation (MIA) as of 31 July 2025. This certification allows the company to produce and import sterile and biological investigational medicinal products in full compliance with Good Manufacturing Practice (GMP) standards.
With this authorisation, SyVento BioTech becomes the first company in Poland authorised to manufacture and release investigational products based on mRNA and lipid nanoparticles (LNPs) for clinical trial use – all under one roof. This milestone positions the company at the forefront of Europe’s advanced therapy manufacturing sector.
“We’re incredibly proud to contribute to the advancement of next-generation therapies and to support our partners in bringing innovative medicines to patients,” said Dominik Lipka, PhD Eng., CTO of SyVento BioTech. “This authorisation not only reinforces our commitment to quality, innovation, and compliance, but also strengthens our position as a trusted partner in the biotechnology and pharmaceutical sectors.”
This development enables SyVento BioTech to accelerate its internal R&D programmes, scale production pipelines, and form strategic alliances across the global biotech ecosystem. The company is now poised to support innovators from early-stage development through to partnerships with leading pharmaceutical companies.
