7 Method transfer
Companies hire us to:
- Analyse and evaluate new contract suppliers (CMO and CDMO)
- Assess the technologies of new suppliers in a neutral way and make a pre-selection of possible contract manufacturers
- Plan and manage the entire transfer project
- To undertake process development and process adaptation
- Monitor implementation and success
Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
MORE We ensure that your production transfer and technology transfer is carried out successfully.
We survey the necessary technological adjustments at the new production site and plan your technology transfer in such a way that as few adjustments as possible have to be made in the dossier. This gives you a safe and fast start of production at the new location, after the successful validation.
In the same project, we bring the manufacturing process up to the latest (regulatory) standards and optimise the production process.
We transfer your analytical methods to the new service provider.
More power together We transfer their methods and technologies to your new supplier or service provider.
Gap assessment and risk analysis
We compare the two production sites or laboratories in terms of equipment, know-how and previous experience. You will receive a detailed overview of the most important differences and whether there are risky steps in the manufacturing process or risky analytical methods.
Planning and tests
Starting from the existing risk assessment, we examine for you which processes and methods require special training and which acceptance criteria can be defined. We include any additional necessary tests in the overall plan and draw up a realistic schedule.
Implementation and performance review
All planned tests are documented and evaluated after they have been carried out.
The comparison with the acceptance criteria that have been met ensures that the technologies and methods have been successfully transferred. This gives you two equivalent laboratories and equivalent validated production sites.
Expand your chances of success. Contact us for a detailed consultation.
1. gap assessment and risk analysis
Several contract manufacturers (CMOs) are usually considered for a production transfer. For the shortlist, we first assess the technological possibilities of the manufacturer ("gap analysis"). For the corresponding product and its requirements, we prepare an initial analysis of how well a contract manufacturer fits in.
The specific requirements may be, for example, batch size and specific equipment and manufacturing authorisation (e.g. narcotics).
So it depends very specifically on the product and which production process is described in the dossier whether a transfer to a certain contract manufacturer makes sense at all.
If the relocation of the production process appears to be feasible, a risk analysis is prepared based on this in order to work out the most important risk factors. At this early stage, this is of course only a rough estimate and not a "risk measurement". Only in the course of the transfer or in the detailed planning will possible problems become visible and be able to be eliminated.
Such gap assessment concerns not only the contract supplier itself, of course, but also all related areas:
- External laboratories
- Suppliers of auxiliary materials and supplies
- Contract packaging and storage
- Logistics chain
We look at all of these areas when "shortlisting" potential contract manufacturers.
Price negotiations with potential suppliers only make sense once the technical possibilities have been analysed in these preliminary discussions.
Only when a transfer seems technologically possible do price discussions make sense.
With the risk analysis, initial estimates can be made as to whether the production transfer can be carried out relatively easily.
Complex transfers with conversion or expansion of buildings and facilities, make investments necessary in addition to transfer costs.
2. planning and accompanying trials and tests
Technology transfers are relatively complex projects as they always involve several departments of a company and several companies at that. Each company has its own structures and ways of thinking, which are not always fully compatible. For the planning of the transfer, it is very important to first establish a common understanding. First we define the common goal, success criteria and the most important steps) and then we start with the detailed work.
We try to back up decisions as well as possible with data. This approach pays off very well financially in the later implementation.
It is rarely possible to implement a production one-to-one. Mostly, adjustments are necessary in the production process. These adaptations are often due to the different types of equipment.
However, certain changes in the production process may also be desired (for example, flexibility in batch sizes, flexibility in manufacturer plants, etc.). Here, too, there are necessary technical adjustments. We obtain our data through carefully planned laboratory trials or tests in the technical centre. This saves us very cost-intensive technical trials ("technical batches"). With the data obtained, we generate simulation models and can thus make good predictions for the technical implementation. They also comply with the "quality by design" specifications and are more flexible in case of later process changes.
3. implementation and performance review
We usually carry out the production itself and its success control in the process validation. There is another opportunity to check and adjust the original risk assessment in the first step of the risk analysis. Parameter ranges that can strongly influence the process flexibility are tested in the validation.
In addition to production, however, all parts of the supply chain that are influenced by it must also be controlled. These are analyses in external laboratories (e.g. release or microbiological controls), contract packaging, logistics chain and storage (e.g. cold storage). Only when the entire chain has been checked and validated with stability samples do we assume that the transfer has been successful. Our success control therefore goes beyond a normal validation batch.
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WHO definition of technology transfer
Transfer of technology is defined as "a logical procedure that controls
the transfer of any process together with its documentation and professional
expertise between development and manufacture or between manufacture