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SyVento BioTech Secures GMP Certificate of Compliance for Manufacturing

COMPANY PROFILE
  • SyVento BioTech has received a Certificate of GMP Compliance of a Manufacturer following a national inspection on April 28, 2026.
  • The certification enables the company to support RNA-based therapies and LNP technologies alongside injectable drug manufacturing and fill & finish services.

SyVento BioTech announced that it has received a Certificate of GMP Compliance of a Manufacturer on April 28, 2026, following an inspection conducted under the national inspection program. The certification is linked to manufacturing authorization no. 285/0662/25 and was carried out in accordance with Article 61(1) of Regulation (EU) No 536/2024.

The company stated that the certification marks a milestone in its development and enables it to expand its contract development and manufacturing organization (CDMO) and contract manufacturing capabilities. The approval supports the company’s ability to manufacture injectable drug products and provide fill and finish services.

SyVento BioTech also indicated that it can support the development of RNA-based therapies and lipid nanoparticle (LNP) technologies. According to the company, it is currently the only organization in Poland offering these combined capabilities within a CDMO service portfolio.

The certification follows an inspection under the national regulatory framework and reflects compliance with Good Manufacturing Practice requirements for pharmaceutical production.

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