From research protocol to GMP manufacture
Pre-GMP infrastructure
Pre-GMP is the process of transferring your research protocol for ATMPs to production in a GMP facility.
Bringing forth projects from basic science to clinical trials is a lengthy and costly process. In particular, the transfer of preclinical projects into approved clinical trials can be complex. The MRCRM helps facilitating this transfer and have as its ultimate goal to oversee the development of advanced therapy medicinal products (ATMPs) that will benefit the patients.
ATMPs are defined as medicines for human use that are based on genes, tissues or cells by the European Medicines Agency. ATMPs are regulated under the Regulation (EC) No 1394/2007 and Directive 2001/83/EC.
ATMP manufacture must comply with Good Manufacturing Practice (GMP). These are guidelines that ensure that the ATMPs are produced consistenly and controlled according to minimum quality standards.
What is pre-GMP?
The manufacture protocol for ATMPs has to be fully optimized and validated before a formal production can start. Pre-GMP includes all the stages for establishing a GMP compliant protocol, including the developmental process, protocol and documentation.
Pre-GMP is the phase of developing and optimizing manufacturing procedures for ATMPs before GMP compliant production a cleanroom facility.
Infrastructure
ATMP Norway pre-GMP facility
ATMP Norway is a national multimodal infrastructure to develop medicines based on genes, tissues or cells. The infrastructure includes a pre-GMP facility, located at Haukeland University Hospital, dedicated to bridging the gap between academic research and clinical application of novel Advanced Therapy Medicinal Products (ATMPs). Our aim is to support the development of a research product into a quality assured product for patient use.
In short, we offer:
- Support in process development including adaption of protocols to GMP standards
- Access to a fully equipped pre-GMP laboratory
- Establishment of necessary quality assurance measures
- Hands-on support with process validation runs
Please visit GMP Infrastructure - Helse Bergen HF to learn more about how our services can support your ATMP development.
Address: BB-building, 7th floor, Jonas Liesvei 91, 5009 Bergen
The Center of Translational Oral Research – TOR-IKO
The laboratory is equipped with state-of-the-art facilities for cell culture, 3-D (bio)printing, and experimental research. Here is a also a core facility for Micro-Computed Tomography (micro-CT) for internal (UiB) and external users.
- Gene analysis
- PCR and RT.PCR
- SuprArray and MicroArray tech
- Protein analysis
- Western immunoblotting & ELISA reader
- Multiplex Suspension Array System (luminescence)
- Histochemistry
- Fluorescence microscope
- Mikro computer tomography
- 3D printer
- Live imaging
- Scanning Electron Microscopy
- Cell culture, normal and hypoxia
- Animal models
- Hard tissue sectioning and staining
- Bioreactor system for dynamic cell and tissue culture
- Bioprinting of living cells
The facility is located at Department of Clinical Odontology (IKO), Årstadveien 19, 5009 Bergen. The scientific leader is prof. Kamal Mustafa.
Visit the facility's website here.
Recommended reading
Silva DN et al: ATMP development and pre-GMP environment in academia: a safety net for early cell and gene therapy development and manufacturing, Immuno-Oncology and Technology, Volume 16, 2022
Travidou A et al: Towards a better use of scientific advice for developers of advanced therapies. British Journal of Clinical Pharmacology, Volume 87, Issue 6 p. 2459-2464, 2020