What we do:
We take the technological adjustments at the new production site into our own hands and design your technology transfer in such a way that the dossier adjustments remain minimal. In this way, we ensure a fast and risk-minimized production start after successful validation.
At the same time, we actively bring the manufacturing process up to the latest regulatory standards and efficiently optimize the production process.
We also take over the transfer of your analytical methods to the new service provider - competently, practically and with a full focus on GMP conformity and budget compliance.
As an experienced QA, MSAT and manufacturing expertWe expand your team hands-on and ensure that your projects are implemented on time, cost-efficiently and with minimal GMP risk - we are not consultants, but your reliable implementation partnerinside.
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.
We have made our mistakes before. We spare them and ourselves. All team members are seasoned managers with many years of experience in manufacturing, supply chain, quality and regulatory.
We know cost pressure and pressure on results from our own experience.
For a production transfer, we actively search for and examine several potential contract manufacturers (CMOs) and carry out a targeted technology gap analysis.
We precisely analyze how well a contract manufacturer fits the specific requirements of your product - for example in terms of batch size, special equipment or manufacturing approvals such as narcotics.
We evaluate the production process in the dossier and make an informed decision as to whether a transfer to a specific contract manufacturer is sensible and feasible.
As soon as technical feasibility has been established, we prepare a detailed risk analysis in order to identify the most important GMP-relevant risk factors at an early stage and address them in a targeted manner (especially in the case of technological adaptations and dossier changes). This is a dynamic assessment that we continuously refine and implement during the course of the transfer and detailed planning.
Our team of experienced QA, MSAT and manufacturing experts acts as an extension of your company - we are not just consultants, but implement pragmatically and hands-on. However, we only supplement your team where an addition is needed. This keeps teams small and fast and costs under control.
We integrate all relevant areas into our assessment: external laboratories, suppliers of additives and auxiliary materials, contract packaging, storage and the entire logistics chain.
In this way, we ensure that budget and GMP compliance are optimally balanced.
Our risk analysis enables you to make a realistic assessment of whether the production transfer is easy to implement or whether complex measures such as conversions or investments will be required.
We keep an eye on costs and timeframes and manage the process to implement your projects on time and with minimal GMP risk.
Technology transfers are relatively complex projects as they always involve several departments of a company and several companies at that.
Every company has its own structures and ways of thinking, which are not always completely compatible. This is often referred to as „cultural differences“ - often overlooking the absolute importance of these differences! We speak 9 languages in our company and are therefore already familiar with some cultural differences from our daily lives.
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“).
In recent years, this has been summarized under the term „AI“. We tend to use the specific terms such as experimental design, multivariate analyses, simulation, etc.
A few years ago, this was still known as chemometrics.
We use the data obtained to generate simulation models and can therefore 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.
We take the pressure off you and your core team for specific projects. We bring in hands-on experience from experienced managers. We organize your projects as "low risk" GMP projects, with maximum speed and within budget. You minimize regulatory risks and have clear responsibilities including a transparent organization. You have a highly experienced project team with a high level of technological expertise. We are 7 experienced practitioners (QA, QC, QM, Manufacturing, Data Science, R&D, Supply Chain) with additional FTEs - depending on the project scope (FTEs from 10 - approx. 40).
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"