GMP Laboratory for Cell Products

  • Introduction
  • Equipment
  • Prices
  • Contacts
  • Publications

The GMP Cell-based Product Manufacturing Laboratory offers services in the fields of

  • clinical tissue banking
  • manufacturing and quality control of cell/tissue based products for clinical use
  • procurement of tissues for research purposes with collaborating hospitals
  • GMP-training and
  • GMP production facility rental.

BioMediTech GMP laboratory is a production facility that provides GMP manufacturing and quality control services for producing cell and tissue based products for clinical use. The scope of production includes both tissue bank and advanced therapy medicinal products.

The cleanroom facility has been designed to accommodate 2 different cell therapy projects simultaneously. The GMP facility operates under a GMP quality system and offers full GMP documentation and support for its clients.

BioMediTech GMP laboratory rents out pharmaceutical industry level cleanroom facilities suitable for testing and production activities. They meet the A/B cleanliness class requirements of the EU Good Manufacturing Practice Guidelines. There is one or two laminar cabinets in each cleanroom.

The A and B class areas are monitored in real time for temperature, pressure differentials and particles of 0.5 μm and 5 μm. The monitoring of particle levels and pressure differentials is connected to an alarm system.

The cleanroom premises are suitable especially for cell production purposes. They can also be used for the performing of quality control analyses which require cleanroom conditions. For production purposes the maximum capacity of the individual rooms is two people.

There is also a separate laboratory for microbiological analyses as well as a laboratory for QC-purposes.

Prices will be defined based on customer needs. Please inquire!

Quality Manager:

Tiia Tallinen, M.Sc. (Eng)
Tel: +358 50 568 0428
Room: ARVO D528

Production Manager:

Annika Hakamäki, Ph.D.
Tel: +358 40 190 1830
Room: ARVO D528

The following publications describe treatments designed and conducted by BioMediTech personnel in collaboration with different university hospitals. The stem cell based products for the treatments have been manufactured in the BioMediTech GMP Laboratory.

Sándor GK, Numminen J, Wolff J, Thesleff T, Miettinen A, Tuovinen VJ, Mannerström B, Patrikoski M, Seppänen R, Miettinen S, Rautiainen M, Ohman J
Adipose Stem Cells Used to Reconstruct 13 Cases With Cranio-Maxillofacial Hard-Tissue Defects
Stem Cells Transl Med, 2014

Sándor GK, Tuovinen VJ, Wolff J, Patrikoski M, Jokinen J, Nieminen E, Mannerström B, Lappalainen O-P, Seppänen R, Miettinen S
Adipose Stem Cell Tissue–Engineered Construct Used to Treat Large Anterior Mandibular Defect: A Case Report and Review of the Clinical Application of Good Manufacturing Practice–Level Adipose Stem Cells for Bone Regeneration
J Oral Maxillofac Surg 2013

Thesleff T, Lehtimäki K, Niskakangas T, Mannerström B, Miettinen S, Suuronen R, Öhman J
Cranioplasty With Adipose-Derived Stem Cells and Biomaterial: A Novel Method for Cranial Reconstruction
Neurosurgery 2011; 68: 1535–1540

Mesimäki K, Lindroos B, Törnwall J, Mauno J, Lindqvist C, Kontio R, Miettinen S, Suuronen R
Novel maxillary reconstruction with ectopic bone formation by GMP adipose stem cells
Int. J. Oral Maxillofac. Surg. 2009; 38: 201–209