We are a laboratory that meets the requirements of a Good Manufacturing Practice, confirmed by a GMP certificate issued by the Chief Pharmaceutical Inspector. We have a modern infrastructure, a competent team and experience in the manufacturing of medicinal products containing human cells.
As one of the few laboratories in Poland, we’ve obtained:
• permission to collect and process human adipose tissue and to process, store and distribute human cells isolated from adipose tissue - Decision of the Minister of Health;
• consent for the manufacturing of Advanced Therapy Medicinal Products – Hospital Exemption (HE-ATMP) - Decision of the Chief Pharmaceutical Inspector;
• permission to manufacture the Advanced Therapy Investigational Medicinal Products (ATIMP) - Decision of the Chief Pharmaceutical Inspector.
We have experience in designing and conducting clinical trials, creating documentation and cooperation with relevant offices, i.e. the European Medicines Agency (EMA), the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the Chief Pharmaceutical Inspectorate.
Unique technical capabilities and certificates held on the Polish scale allow LBBK for completely legal manufacture of medicinal products such as:
• Advanced Therapy Investigational Medicinal Products (ATIMP),
• Advanced Therapy Medicinal Products – Hospital Exemption (HE-ATMP).
Therefore, the Laboratory for Cell Research and Application is a perfect partner for individuals (companies and universities) interested in cooperation in the field of conducting research and developing therapies based on cells and tissues.