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Independent of suppliers and contract manufacturers (CMOs). Consulting and implementation.
Technology transfer in the pharmaceutical industry is the transfer of a manufacturing method from one production site to a new production site. The transfer determines the future cost structure. Carry out the transfer in a way that suits you!
We are independent of suppliers and contract manufacturers and can effectively represent your points of view.
This saves you valuable time and gets you to market faster!
A technology transfer is a typical multifunctional process. Numerous departments and several company partners are involved. This results in a number of "surprises" and also many opportunities for process improvement.
Contract manufacturers are usually more flexible with batch sizes and have different shearing technologies at their disposal. This results in much greater flexibility in production and can lead to shorter replenishment times.
Many products in biotechnology are developed by start-ups. Naturally, there are no or only very limited production options there. Contract manufacturing is the only way to produce industrial quantities under GMP conditions and bring them to market.
The transfer of production to a new production site affects the entire supply chain. It makes sense for all auxiliary materials at the new production site to be used by the contract manufacturer. This results in synergy savings in procurement. This is not always possible. If certain auxiliary materials/excipients are specified in the dossier, they can only be changed with a certain amount of effort.
The new (external) production location usually also has different production planning with different delivery times and minimum stock quantities. These details have a major impact on the minimum batch size and the minimum order quantity. It is therefore advisable to plan the correct batch sizes when transferring technology and to take them into account during validation. If the transfer takes place directly from a development laboratory, the process must of course first be adapted for industrial production. We carry out a scale-up.
These adjustments are very critical parameters. The effects become apparent if you want to relocate production again later. These settings then determine which other contract manufacturers are even considered. A poorly designed process makes a possible subsequent technology transfer very difficult and expensive.
The supply chain also includes external analytical laboratories and their certifications. Here it can make sense to use the laboratories of the contract manufacturer.
Production transfer in pharmaceutical manufacturing is subject to strict GMP rules. Very precise planning with all departments and companies involved is crucial to the success of the transfer project. A very important point in every project team is to agree on common standards.
This is not always easy, especially with regard to documentation and procedures, as each company has its own standard procedures. If each partner company insists on its own SOPs ("Standard Operating Procedures"), transfer projects often turn into gigantic bureaucratic graveyards. Even small transfers consume several man-years of project time. This not only senselessly increases direct project costs, but also delays the time at which the new product is marketed. This results in high opportunity costs.
The basic prerequisite for any successful transfer is the establishment of a project team capable of making decisions and precise documentation of the planning and process. These documents form the basis for the subsequent submissions to the authorities to adapt the dossier.
An important task in technology transfer is also to bring production methods up to date. This status is then documented in the adapted dossier.
In our experience, it is better to take care of the technical and technological implementation first. Only when you are sure that your product will be manufactured to a high quality at the new production facility can you start to implement all the documentary requirements arising from statutory regulations.
The aim of all activities is to produce your product to the highest quality. The necessary documentation and project planning are subordinate to this goal.
The basis of all transfer activities is a solid understanding of the manufacturing technology used. If new technologies or new systems are used at the new manufacturer, the entire manufacturing process must be rewritten for these new systems.
This is only possible on the basis of test data. Either from the laboratory or from technical trials. In our experience, it really pays off financially to test technical issues (e.g. setting ranges for parameters such as mixing times, temperatures, etc.) in small-scale tests in the laboratory or technical center.
Only then can well-founded decisions be made for implementation in everyday industrial production. This procedure complies with the "Quality by Design" specifications and saves costs in the long term when it comes to implementation in industrial production.
Technology Transfer is the process of transferring skills, knowledge, technologies, and methods among governments and universities, as well as non-profit and industry organizations, to make sure that a wider range of users has access to scientific and technological innovations created by FDA scientists.
