What role do Downstream Operations play in the purification process of active ingredients? Nicola Cornella, Head of Downstream Operations in SUANFARMA Italia, tells us all about it in this interview.
What does Downstream Operations mean?
The term Downstream identifies the stages in which the purification of the molecule of interest from a complex matrix produced in the Fermentation Operations department takes place, which constitutes the Upstream production segment. The isolation process involves the use of different tools and equipment that act on different chemical/physical parameters leading to the purification of the active ingredient in sequential steps. The final isolate can be used for subsequent rework or formulations that will finally lead to the form distributed to patients.
What technical skills and soft-skills are critical to succeed in your role?
Encompassing tools and machines that are very different mechanically and operationally, Downstream Operations requires technical skills in multiple areas, to be specialized then in relation to the molecule being purified. Different active ingredients in fact have different needs when processed by the same machine. This diversity of equipment also inevitably leads to a diversity of peculiarities and problems that may affect the tools and process steps, which are not always easy to identify and solve. In any case, complexity is also a source of great fascination and stimulus to learn and grow: curiosity and willingness to learn and improve, as well as the ability to problem-solve, are definitely soft-skills that I see as fundamental to this role. An important part of the function I hold is then the coordination of activities and personnel working in Downstream Operations, tasks that require organizational and management soft-skills. Finding ways to make the team work to the best of their abilities and possibilities makes it easier to meet challenges and achieve goals.
What are the complexities of working in a pharmaceutical company like SUANFARMA?
Like a living being with its organs, a pharmaceutical company is composed of various departments, which working in concert contribute to its operation and the production of quality drugs in the volumes required by patients. The Manufacturing Operations departments are materially concerned with the production of active ingredients, but they are supported by a number of other departments and functions whose precision and activity are critical. Being able to manage the demands and needs according to the priorities of the different departments is one of the most complex factors in this environment and a challenge that is overcome with the strength and professionalism of the team and awareness of common goals.
What is the most satisfying part of your job?
In general, being able to meet our partners’ demands, in terms of volume and quality. This translates into being able to run the Downstream Operations machine in an efficient and coordinated way in all its various aspects. More specifically, understanding the principles instrument operations, both from a purely mechanical point of view and in relation to the purification of active ingredients gives me a lot of satisfaction, because each time I add a piece to the mosaic and feel that I become more competent. Then when these notions help to overcome challenges and improve processes, it is a double satisfaction.
The same is also true in the management and organizational areas. Seeking and then being able to engage, stimulate and motivate my employees is another part of the job that I really enjoy and which then leads to an overall improvement of the work environment and the strength of the team.
Three words to describe SUANFARMA
Team: we are a group of people and collaborators with great passion for our work, which makes collaborations effective and motivating.
Challenge: continuous improvement from both the process and energy resource management perspectives is an exciting daily challenge.
Growth: delving into various production, management and regulatory aspects of the pharmaceutical world and coming into contact with numerous people and functions allows for significant personal and job growth.