Beatriz Brotons Silvar, Quality Manager of Asac Pharmaceutical Immunology, gives us her views on development and research in the field of immunotherapy and her day-to-day work in the technical department.
- What does the work of a quality manager in a laboratory like ASAC Pharmaceutical Immunology consist of? What’s it like day-to-day?
My job at API is to manage the Quality Control. At a practical level the technical department is multidisciplinary; we all participate and interact in order to maintain the Quality System and guarantee the quality of our products and regulatory compliance. It’s very important to be critical and to implement improvement actions.
- What’s the greatest challenge you’ve faced as a quality manager?
In 2017, the company made a great future commitment by remodelling the manufacturing plant, preparing facilities, equipment and production and quality control processes in order to comply with the regulatory needs and the Quality Policy. It was a huge task at a technical level, but we’ve got a great team who made it possible to carry out this project.
- What’s the latest in allergenic immunotherapy regarding research and the development of new products? And in bacterial immunotherapy?
In recent years, a clear increase has been observed in the prevalence of allergic disease. Among other issues, the research commitment and development of new products should be focused on new allergens and/or allergens of lower incidence, in order to ensure the availability of treatment for all patients. This is something many administrations should value or are already valuing, that it’s important to ensure product quality, safety and efficacy, but to the same extent it’s important to guarantee their availability.
Regarding bacterial immunotherapy, in Spain the commitment is to auto-vaccines, where we start with the sample taken from the patient; outside Spain we work with the most prevalent strains of bacteria which cause repeat infection. In both cases, they are low industrialised processes, something to take into account given the environmental situation, being one of the future solutions to the current problem of antibiotic resistance.
- How do you keep up to date with the latest therapeutic innovations?
It’s not at all easy, as everything takes time; I try to read everything I can, the feedback which reaches us from the sales/marketing department is also important, as well as attending conferences and workshops. I believe it’s important to equip the specialist with all the therapeutic and diagnostic tools possible, we have to keep working in this way and continue with the commitment to research and development.
- Do you think that in Spain we’re very advanced in the field of immunotherapy?
One of the remaining challenges in Spain is the sublingual vaccine, the efficacy of which was historically very much in question, given that in many cases the sublingual treatment presented the same concentration as the subcutaneous treatment. It’s not like that now and I believe we should take advantage of the many benefits that sublingual versus subcutaneous treatment entails.
- What are your short- and long-term perspectives as a technical department?
Ultimately, the objective of the technical department is to ensure the quality of the products manufactured and regulatory compliance. This, in a field where the regulatory requirements are increasing all the time, is a constant task of optimisation and continuous improvement.
- How do you ensure maximum quality is obtained in all products?
In one way or another, all members of API participate in maintaining the Quality System, all being essential parts. It’s very important to have engaged and qualified staff in the Quality Control and Quality Guarantee department, and we’ve achieved this, we have a great team, but as I’ve said we all participate, starting with Management. It’s essential that we’re all involved in the Quality Policy.
- Do you believe that communication between the technical department and the sales/marketing department is important?
More than important, I’d say that it’s vital or of mutual necessity. We have a common objective, to make safe and effective treatments available to the patient, giving the professional a wide portfolio of high quality, innovative and competitive products and we need to work closely together in order to achieve this.
