Production of pharmaceuticals for clinical use
To support you in the planning of a pharmaceutical project, we here describe the different steps in the drug development process.
Formulation and production development
In parallel to the establishment of a plausible mode of action for a treatment during the preclinical phase, it is also important to begin with the development of the pharmaceutical product, where there are many questions to address:
- Is the treatment amenable to production and formulation on an industrial scale?
- Is the projected human therapeutic dose reasonable?
- What are the major costs involved?
- What is the state of the current competition, and will other competitive products be available at launch time?
Manufacture and GMP
The manufacture of the experimental pharmaceutical candidate must take place according to good manufacturing process (GMP) principles. This involves the use of controlled steps at all points in the process, and that all composite raw materials are strictly documented and traceable in their origin.
However, before GMP manufacturing can occur, the process has to be optimized. Additionally, methods and protocols for formulation have to be developed, which match the particular therapeutic entity and its projected clinical use, again with strict control over the raw materials involved. The localities used to perform all of these steps, as well as the personnel performing them, must also be approved. This is all performed in the build-up to GMP manufacture. Every individual GMP approval is product/process specific and is issued by the Swedish Medicinal Products Agency.