2024-10-16 07:42:00
Chiesi plays at home for the inauguration of its bioproduction center. In Parma, the Italian laboratory is omnipresent, with sites spread all over the city, to the point that even taxi drivers can make mistakes. As a good ambassador, the general director of Chiesi, Giuseppe Accogli, never misses an opportunity to promote the city of Emilia-Romagna. Chiesi holds on to its roots and this anchoring, its logo does not represent a boat anchor by chance.
And its new flagship, a bioproduction center, is impressive. Its anthracite-colored facades look great in the sunshine that still reigns in Parma at the end of September. In the city where it was born almost 90 years ago – the laboratory will celebrate them next year – Chiesi saw the big picture and dedicated a budget of 400 million euros to this project, including €120 million for the infrastructure alone of this new center, witness to the group’s ambitions in bioproduction. “A very important investment for a laboratory of our size”recalls Giuseppe Accogli, while the group reached a turnover of €3 billion last year.
“We are a family laboratory, we do not have the mentality of a company listed on the stock exchange and we have complete freedom to invest,” underlines Giuseppe Accogli who presents sales as “fuel to reinvest in innovation”. Chiesi thus reinvests 24% of its revenues into R&D. And wants to develop in the rare diseases segment, which currently represents a large quarter of its sales. “Rare diseases are a priority, we must remember that only 5% of these diseases have a treatment”specifies the manager. The segment, and its niche markets, also offer the advantage of less head-on competition with the big names in pharma.
To exist in this market, Chiesi has increased partnerships in recent years, notably with the Belgian laboratory UCB, in 2021, with Affibody, in 2023, or even recently, with Oak Hill Bio and Gossamer Bio. He also acquired Amryt Pharma, for nearly $1.5 billion, at the start of 2023. Enough to expand his portfolio. “We entered this area ten years ago with acquisitions, partnerships, and we have four products already approved and on the market”explains Diego Ardigò, vice-president in charge of R&D.
Chiesi thus markets lamzede (velmanase alfa, indicated for a rare disease, alpha-mannosidosis), elfabrio (pegunigalsidase alpha), two enzymotherapies which will be produced on the new site, while two other treatments will also soon come off the lines , revcovi and myalepta. “We don’t want to transfer everything to this site”nuance Antonio Magnelli, vice-president in charge of the Global Manufacturing division. “We will have a sort of double sourcing, which will ensure that the patient is provided with their treatment. Redundancy is a good investment for patients »he assures.
This quality of supply is a factor put forward by Chiesi to explain the internalization of this bioproduction. “We had analyzed many of the risks linked to production by external service providers”explains Diego Ardigò, “ hence this choice to go internally”he insists. But Chiesi did not do things by halves, opting for a site that was both versatile and capable of ensuring production from one end of the value chain to the other.
A fully integrated site
For the moment, only the surfaces of fill & finish are visible. On each side of the corridor, large bay windows open almost to the ground and offer rare transparency in a pharmaceutical installation. “For this type of production, without opening to the outside, this possibility of seeing our colleagues or the installations offers additional comfort for those who work inside”tells us an employee of the site.
The upper floor houses an XXL isolator which extends from one end of the room to the other. “65 openings on both sides”says Alberto Ubertalli, process engineer. Despite the massive size of the facilities, it is the flexibility that Chiesi chooses to highlight. “We are capable of going from small quantity production, for clinical batches, to a large scale”savor Antonio Magnelli.
The Chiesi site will thus be able to both manage the phase upstreamwith reactors ranging from 250 to 2,000 liters at downstreamand up to the freeze-drying and filling phase, with product bottles ranging from 2 ml to 100 ml. Packaging and serialization are also planned on site, which are rather rare capacities on bioproduction sites where the fill & finish often has separate areas.
And on the biomedicines side, here too, versatility remains essential. “We have chosen a production system using mammalian cells, this will allow us to work on antibodies, enzymes or proteins”underlines Antonio Magnelli, specifying that, for the moment, Chiesi does not plan to make its capacities available to third parties. “With this investment, we have chosen to be at the cutting edge of technology”he adds.
If Chiesi wanted an evolving site, it is because the installation must be long-term, becoming “an essential link” future developments, as described by Diego Ardigò (R&D). The site will work hand in hand with Chiesi facilities in Sweden, which specialize in drug substance.
Ultimately, 200 people should join the site to deploy all stages of production. And Chiesi would like not to be alone in the field. Because in Italy, as in France, the inauguration of a bioproduction site remains a small event, according to the number of officials who made the trip, including the Italian minister in charge of higher education and research, Anna Maria Bernini.
And, on the other side of the Alps, the same complaints are coming back from the mouths of pharmaceutical manufacturers: the need to stabilize the prices of medicines or even to reduce the delays between authorizations and marketing. “Since we laid the first stone of this project, a lot has happened for bioproduction in Europe”however, believes Alessandro Chiesi, the president of the laboratory who underlines the need “to have a common vision in Europe” to catch up, or prevent the continent’s lag behind China or the United States from worsening.
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