CONTRACT DEVELOPMENT AND MANUFACTURING ORGANISATION (CDMO)

CDMO

GaiaCell is a contract development and manufacturing organisation (CDMO) operating in the field of cell-based therapeutics. The development of our own products, which have been successfully employed in clinics, provided us with crucial knowledge and experience that can be employed in future projects. We are collaborating with a strategic partner for the development of point-of-care networks, cell- and gene-based therapeutics, and technological platforms for use in cancer immunotherapy.

Class B clean rooms are equipped with laminar airflow hood (Class A) in which crucial manufacturing steps are carried out. During the process, we ensure quality control of intermediate and final cell products in accordance with the guidelines and the European Pharmacopoeia. The laboratory is also registered for working with GMO biosafety level 2.

GMP

75 m² of cleanroom areas, where we provide cGMP manufacturing services
two Class B clean rooms
Class D clean room
separate corridors for personnel and materials
regular microbiological and environmental controls
regular control of particulates in class A and B
constant control over temperature, humidity, and air pressure quality control of intermediate and final cell products in accordance with the guidelines and the European Pharmacopoeia
storage capacity with controlled conditions for raw materials, intermediate and final cell products (storage of products at refrigerated, ultra-low and cryopreservation temperatures).

POC

The point-of-care laboratory (POC laboratory) manufactures advanced therapy medical products (ATMPs) according to GMP guidelines in proximity to the patient or hospital. For many patients and hospitals, the short shelf life and stability of ATMP (in some cases less than 3 days) presents an accessibility bottleneck for such drugs. To overcome logistic and administrative problems, future development on the field of ATMP manufacturing focuses on the establishment of POC laboratories near the hospital environment.

In a collaboration with our global strategic partner Orgenesis Inc., the goal for the near future is to develop a POC laboratory named OMPUL (Orgenesis Mobile Processing Units and Labs). OPMPUL is a multipurpose, mobile, autonomous laboratory unit for ATMP manufacture according to GMP guidelines.

R&D

The research and development laboratory consists of 3 connected laboratories: work on cell cultures (isolation, cell cultivation, freezing cells, and other cell manipulations) is carried out in the first part of the laboratory, whilst analytical methods (molecular-biology methods, biochemical methods, and analysis on flow cytometry) are performed in the second and third parts of the laboratory.

The research and development laboratory is registered to work with genetically modified organisms (biosafety level 2).

CONSULTING

Based on many years of experience, we offer consulting in the fields of:

Laboratory GMP certification for ATMP manufacturing
Laboratory registration for working with GMO biosafety level 2
Authorisation for human tissues and cells for therapeutic purposes in compliance with Slovenian legislation
Obtaining licenses for drugs intended for advanced treatment in clinical trials – iATMP
Design and maintenance of GMP-compliant clean room facilities (clean room class D and B)
Technology and process transfer from R&D to GMP environment