TISSUE ESTABLISHMENT

Linio Biotech operates a licensed tissue establishment — a core strategic asset that underpins our scientific, clinical, and commercial activities.

Unlike most early-stage companies, Linio Biotech has built in-house, regulated infrastructure that enables end-to-end control of tissue sourcing, processing, quality assurance, and product release. This capability forms the foundation for scalable, compliant, and reproducible products.

Clean room and laboratory infrastructure

The facility comprises multiple clean rooms (EU GMP Class A/C), including dedicated areas for tissue processing, aseptic manufacturing and quality control testing.

Clean rooms are subject to:

  • Continuous environmental monitoring (temperature, humidity, air pressure, particle levels)
  • Routine microbial monitoring during production and cleaning
  • Annual qualification in accordance with EU GMP classification requirements

In addition, the facility includes dedicated quality control (QC) laboratories and research & development laboratories, enabling close integration between development, manufacturing, and quality.

All operations are carried out by highly qualified personnel, ensuring compliance with applicable regulatory, safety, and quality requirements.

Fully validated processes and in-house quality control

All tissue establishment activities are fully validated and governed by detailed instructions designed to ensure patient safety, regulatory compliance, and consistent high quality.

The production process is aseptic and conducted in A/C class clean room environment by trained specialists. Our in-house QC laboratory performs all validated quality control analyses required for batch release, including:

  • Sterility testing
  • Endotoxin testing
  • Protein analysis

All analyses are performed in accordance with relevant pharmacopoeia standards and must meet predefined specifications prior to product release.

Operations are governed by a comprehensive quality management system (QMS) and standard operating procedures (SOPs). The status of the tissue establishment, QMS, and all key processes are reviewed annually to ensure continuous compliance and improvement.

Licensed and authorized for end-to-end tissue operations

The tissue establishment license TE4008 was granted in 2021 by the Finnish Medicines Agency Fimea.

The license authorizes Linio Biotech to perform the following activities:

  • Evaluation and testing of the suitability of adipose tissue donors
  • Procurement of adipose tissue for allogeneic use
  • Processing, preservation, and storage of adipose tissue
  • Preservation and storage of final products
  • Distribution of final products for human application
  • Importation of adipose tissue from EU / EEA countries
  • Distribution within EU / EEA countries and export to third countries

This authorization enables full control of the value chain, from tissue sourcing to international product distribution.

Regulatory compliance and strategic significance

Linio Biotech’s tissue establishment complies with all applicable EU and national regulatory requirements governing human tissues and cells, including:

  • Commission Directive 2004/23/EC
  • Commission Directive 2006/17/EC
  • Commission Directive 2006/86/EC
  • Act 101/2001 on the medical use of human organs, tissues and cells
    • Government Decree 773/2007
    • Ministry of Social Affairs and Health Decree 1302/2007
    • Fimea Administrative Regulation 3/2014

Beyond compliance

This infrastructure represents a significant strategic moat. Establishing and licensing a tissue establishment requires years of regulatory engagement, operational expertise, and capital investment.

For partners and investors, this backbone:

  • Reduces manufacturing and regulatory risk
  • Enables rapid development iteration
  • Supports scalable pipeline expansion
  • Increases long-term strategic value