Fine Foods & Pharmaceuticals N.T.M. S.p.A. is an Italian independent Contract Development & Manufacturing Organisation (CDMO). It develops and manufactures contract products for the pharmaceutical, nutraceutical and cosmetics industries.
The Group, and particularly the pharmaceutical division, considers it essential to introduce new products through technology transfer development.
The pharmaceutical sector is proceeding along two parallel lines – the search for innovative therapeutic strategies, which is the prerogative of multinationals able to invest significant resources in the long term, and maintaining a therapeutic level with primary care drugs that guarantee suitable solutions and drug quality.
Transferring a drug normally used in established therapeutic practice, entails a careful assessment of partners. Moving from an original production site to a CMO requires evaluating financial and the receiving organisation’s quality and reliability parameters.
When a technology transfer process is applied to drugs that have been on the market for decades, a series of aspects must be considered. This includes equipment that has changed and improved (even if the basic technologies remain unchanged) and the availability of excipients that can improve the drug’s features, without changing its formula.
While following the specifications and the scope of sustainable regulatory changes, it is possible to improve product quality and add value to a drug that will continue to play its therapeutic role over the years.
The correct mix of experience, process knowledge and involvement of organisation components decides the success of the technology transfer process. It is a complex activity involving a series of codified steps that must not be taken for granted.
A technology transfer project consists of four critical steps, and each is crucial for the project continuation.
- Feasibility and Gap Analysis is a key step that must clarify the process applicability with the available production equipment and the critical issues that may emerge during the subsequent project phases;
- Transfer of analytical methods and Batch engineering is essential to validate/transfer the recorded analytical methods before starting the preliminary production phases. The subsequent production of batches on a pilot or industrial scale is particularly complex. Its purpose is to identify and resolve any critical issues that may arise during production. These steps identify details that will have to be fine-tuned to optimise future stages;
- Industrialisation phase and validation batches. This is the real “litmus test”, every detail and production step must be perfect. This is a non-return phase, everything must be consistent with the objective, there can be no “questionable” information or specifications, and what has been established in the production process must be sufficiently strong to be replicated in all future situations;
- Documentation preparation for the submission of the regulatory file for including a new manufacturer. An important step, the result of a strategy included in the Gap Analysis that must be managed competently and intelligently to avoid problems that could lead to project slowdowns.
At the end of these phases, the production of commercial batches will follow.
Involving the entire organisation from the early stages is crucial to achieving Fine Foods’ successful results. Coordinated by a project leader, all company departments will take part in the process including procurement, the pharmaceutical technology laboratory, technical services, and the customer-fronting sales team streamlining and balancing the flow of information needed to develop the transfer plan.
This is the reason why the Group created a dedicated team which has a proactive and constructive approach to the search for innovative and valuable solutions that can meet and anticipate customer needs and builds on the experience developed in major international companies.
The average number of transfer projects at Fine Foods in the last few years was eight to ten annually. This commitment guarantees the pipeline development and is at the heart of the pharmaceutical division’s business model. This is possible due to the organisational solidity, established flows and teams that combine extensive experience, expertise, discipline and the desire to improve underlining the Fine Foods’ pharmaceutical model.
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Berlino 39
24040 Zingonia/Verdellino – Bergamo, Italy