The pharmaceutical industry’s main objective is to provide the market with effective medicines that increase the quality and life expectancy of society.
One of the great progresses in recent years has been advanced therapies, as they have opened hope for treating important hereditary and acquired diseases.
What are advanced therapies? These are very innovative medicines that are based on the use of genes (gene therapy), cells (cell therapy) and tissues (tissue therapy) to treat diseases or prevent them. Why are they so relevant? Because they have a high potential to design personalized treatments for the patient, thereby becoming a new key therapeutic tool in the medicine of the future to deal with diseases that until now had no effective treatment possible.
But the development of these advanced therapies presents some challenges, one of them starting at the beginning of everything: the facilities in which to conceive them.
It is absolutely necessary to have special facilities to guarantee manufacturing under GMP conditions, , meeting the highest quality standards. Whether the purpose is a clinical trial or commercialization, the production of these advanced therapies must be carried out within a legislative framework in which they are considered medicines. And that is why it is necessary to have specific production laboratories and be governed by the Good Manufacturing Standards.
The manufacturing of advanced therapies must be carried out in clean áreas, as sterile products. Furthermore, access to these clean rooms must be through passage systems for people and materials. Likewise, it is required that an adequate level of cleanliness is maintained, as well as exhaustive control of air quality.
Several aspects will therefore have to be taken into consideration:
- • Personnel protection
- • Product protection
- • Environmental protection
At Albian Group we have extensive experience in creating these facilities focused on the field of advanced therapies. In addition, we can provide technical, regulatory, strategic and quality systems consulting in the field of advanced therapy medicines and innovative drugs. We study the specific needs of each project to design the best solution. Each project executed of this type makes us feel great satisfaction as we see that it makes possible the development of therapies that will change the lives of so many people.