Good Manufacturing Practice
The groups within the Applied Radiation department that are focused on product development are responsible for performing pipeline research to retain and enhance Necsa’s status as an internationally competitive radiochemical isotope producer, thus contributing to enhancing the quality of life. In addition to these groups developing precursors to radiopharmaceuticals there is also an emphasis on the development of new radiopharmaceuticals which is further down the value chain. The GMP group plays a pivotal role in this process by translating promising lead compounds identified during basic and then pre-clinical research into a GMP compliant preparation of the investigational new drug that can be assessed through clinical trials.
**THIS DIAGRAM IS FROM A WEB SOURCE: https://www.edrawmax.com/templates/1019133/ which must be acknowledged or the diagram redrawn .**
The World Health Organisation defines Good Manufacturing Practice (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) as “the aspect of quality assurance in relation to ensuring that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals.” The GMP group in Applied Radiation has a specialised skill set in this area that is necessary for the translation of matured technology into a commercial outcome in relation to the Necsa Group’s radiopharmaceutical business. The group has been successful in achieving production of radiopharmaceuticals for clinical trials, market penetration studies for new radiopharmaceuticals and lyophilised kit development for commercialisation.
Research programs
The group works closely with the radiolabeling and pre-clinical groups in the Department to progress qualifying radiolabeled compounds that have shown promise in pre-clinical studies further down the radiopharmaceutical development pipeline.
Capabilities
- Labelling Laboratory which is a cleanroom that is operational and maintained to GMP standards. The facility is fully equipped for the small-scale synthesis of radiolabelled compounds for clinical trials and market penetration studies. The facility has an automatic synthesis unit in a hot cell for the production of PET tracers and an HPLC with radio detectors for the subsequent quality control.
- Ability to develop GMP compliant kit formulations for radiopharmaceutical preparation.
- Extensive experience in writing of licences, drug master files, quality and validation reports that are GMP compliant.
Achievements
Development of a single vial 68Ga-PSMA kit for treating prostate cancer:
Gallium-68 (68Ga) is a new, exciting PET imaging radioisotope with a relatively short half-life of 68 minutes. This poses challenges to the synthesis of 68Ga labelled compounds at radiopharmacy facilities and shipment to hospitals thereof. The solution to this limitation is a lyophilised (cold) kit formulation where the 68Ga is added in the hospital and the preparation is ready for injection after 10 minutes, otherwise referred to as a “shake and shoot” kit formulation. The 68Ga eluate can be added to a variety of molecules for different indications.
The most recent molecule of interest is the Prostate-Specific Membrane Antigen (PSMA), which is selective for primary and secondary prostate cancer. The GMP Formulation Group has developed a single vial PSMA-11 kit that has passed the technical feasibility study and is currently undergoing GMP compliance before production and distribution under a Section 21 authorisation from the SAHPRA
Phase I/II Clinical Trial for the 195mPt-cisplatinum Companion Diagnostic (Medical Diagnostic and Therapy impact area project)
Part A of the phase I/II clinical trial on the use of 195mPt-cisplatinum as a companion diagnostic to optimise and individualise the dose for patients, funded by the Technology Innovation Agency (TIA) for completion of the trial preparation phase was achieved. The next phase (Part B) is execution of the trial. A due diligence for this part was completed with TIA and a GMP license is in process in order to produce the 195mPt -cisplatinum for clinical trials.
A new non-invasive therapeutic application for skin cancer produced locally for the first time
Rhenium-SCT® (Skin Cancer Therapy) is a specialized state-of-the-art skin brachytherapy that utilises the beta-emitter Rhenium-188. This therapy is indicated for the treatment of Basal Cell and Squamous Cell Carcinoma. Rhenium-SCT is a single session, non-invasive, out-patient treatment which is provided by OncoBeta GmbH (Germany), a pioneer and innovator in the epidermal radioisotope sector that currently supplies Rhenium-SCT to the European, Australian and South African markets. The GMP group was contracted by OncoBeta to produce doses of this non-invasive therapeutic application for skin cancer for local clinics (a successful shipment to a Nuclear Medicine clinic in Australia was also demonstrated) as part of a market penetration study. Several doses were successfully produced and supplied to local hospitals for patient treatment.
