Companies commission us to:
Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
We determine the necessary technological adjustments at the new production site and plan your technology transfer so that as few adjustments as possible need to be made to the dossier. This gives you a safe and fast production start at the new location after successful validation.
In the same project, we are bringing the manufacturing process up to the latest (regulatory) standards and optimizing the production process.
We transfer your analytical methods to the new service provider.
We compare the two production sites and laboratories in terms of equipment, know-how and previous experience. You will receive a precise overview of the most important differences and whether there are any risky steps in the manufacturing process or risky analytical methods.
Based on 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 tests required in the overall plan and draw up a realistic schedule
All planned tests are documented and evaluated after implementation.
The comparison with the adhered acceptance criteria 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.
Several contract manufacturers (CMOs) are usually considered for a production transfer. For the shortlist, we first assess the technological capabilities of the manufacturer ("gap analysis"). For the relevant product and its requirements, we prepare an initial analysis of how well a contract manufacturer fits in.
The specific requirements can be, for example, the batch size and specific equipment and the manufacturing authorization (e.g. narcotics).
It therefore depends very specifically on the product and which production process is described in the dossier as to whether a transfer to a particular contract manufacturer makes sense at all.
If the relocation of the production process appears feasible, a risk analysis is carried out on this basis to identify 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 during detailed planning will it be possible to identify and eliminate potential problems.
Of course, such gap assessments affect not only the contract supplier itself, but also all related areas:
We consider all of these areas when shortlisting potential contract manufacturers.
Price negotiations with potential suppliers only make sense once the technical possibilities have been analyzed in these preliminary talks.
Price discussions only make sense when a transfer appears to be technologically possible.
The risk analysis can be used to make an initial assessment of whether the production transfer is relatively easy to carry out.
Complex transfers involving the conversion or expansion of buildings and facilities require investments in addition to the transfer costs.
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 completely compatible. When planning 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 our decisions as well as possible with data. This approach pays off very well financially when it comes to subsequent implementation.
It is rarely possible to implement a production one-to-one. In most cases, adjustments to the production process are necessary. These adjustments are often due to the different types of system.
However, certain changes may also be required in the production process (e.g. flexibility in batch sizes, flexibility in manufacturing systems, etc.). Here too, technical adjustments are necessary. We obtain our data through carefully planned laboratory tests or tests in the technical center. This saves us very cost-intensive technical trials ("technical batches"). We use the data obtained to generate simulation models and can thus make good predictions for the technical implementation. They also comply with the "quality by design" specifications and are also more flexible in the event of subsequent process changes.
We usually carry out the production itself and monitor its success during process validation. This gives us another opportunity to check and adjust the original risk assessment in the first step of the risk analysis. Parameter ranges that can strongly influence process flexibility are tested during validation.
In addition to production, all parts of the supply chain that are affected by this must also be checked. This includes analyses in external laboratories (e.g. release or microbiological controls), contract packaging, logistics chain and storage (e.g. cold storage). We only assume a successful transfer once the entire chain has been checked and validated with stability samples. Our success control therefore goes beyond a normal validation batch.
Contact one of our experts to discuss your challenge.
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
sites"
