Outsourcing and technology transfer
We handle complete outsourcing and technology transfers in the pharmaceutical industry to a new manufacturer. Often, optimisations and adaptations to new production equipment are required. Your advantage: You do not need additional resources and have a competent contact person.
Technological adaptations, scale up to new batch sizes, conversion of manufacturing technologies and still maintaining the regulatory required "similarity" of the production process is our speciality.
The successful technical adaptation is the guarantor for a stable process with high yields, without faulty batches and for low costs.
Optimisation in the technical centre
In our own laboratory and technical centre in Geneva, we can carry out certain optimisations and analyses. If special equipment is required (for example: freeze-drying, coaters for release coatings), we use partner facilities.
Correct laboratory optimisations save technical batches and thus reduce costs and accelerate the transfer time. The foundations for dossier changes are also laid here, in order to design the transfer under "similar technological conditions", so that it is classified as low as possible in the variation guideline. This shortens the time for the necessary dossier changes. The product can therefore be on the market more quickly.
We can investigate defects, impurities, machine problems with our own analytical methods and can so eliminate the root causes.
Our simulation tools help us to find the right process adjustments and to use those correctly in production. This keeps the number of technical batches at a minimum and thus the costs low.
The essential steps of a production transfer in the pharmaceutical industry
- Tendering the production and obtaining offers
- Selection of suitable contract manufacturers/CMOs or CDMOs
- Setting up the project team
- Alignment of objectives and preparation of the project plan
- Implementation of the different project phases
- Completion of the transfer - usually through the successful process validation or through positive results in the first stability investigation.