Catalent keeps adding on at key Italian plant, this time with a pair of new bioreactors and 100 jobs
For the second time in less than six months, Catalent will upgrade its sleek new facility in Anagni, Italy, this time to add biologics drug substance manufacturing capabilities to support an increase in demand.
Two new 2,000 liter single-use bioreactors with new manufacturing suites will support early-phase clinical development and late-stage commercial transfers, the company said in a press release, as well as space for another six bioreactors to be added in the future. The project is expected to add 100 new employees, and it should be operational in April 2023.
Upon completion, the expansion will have 16,000 liters of manufacturing capability. Batches will be able to range from 2,000 to 8,000 liters. The program will cost about $100 million, and Catalent’s EVP of Marketing and Strategy Bernie Clark said that though the company hasn’t signed off on adding the subsequent bioreactors, it can happen in “very short order,” and Catalent’s plan is to max out the facility.
“Catalent is committed to supporting customers from small and virtual biotechs to large biopharma companies that require the right capabilities, scale of capacity, and integrated solutions to meet their needs for new biologic therapies and vaccines,” Regional Biologics President for Europe Mario Gargiulo said in a press release. “Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations.”
The plant was acquired from BMS in 2019, and the CDMO was drawn to it, largely because of site’s experiencing launching products into seven or eight new markets a year, and its state-of-the-art, nearly untouched vial filling lines. The original plan wasn’t for a global pandemic to break out, but once it did, Catalent upped its vial filling, inspection, labeling, and packaging services there.
“It usually takes some time to start filling capacity and having higher levels of utilization on any new line, it’s a process that could take months or years, but what was really interesting in the time frame was that Catalent, who has a lot of experience doing tech transfer and scale up had these new assets,” Clark said in a phone call to Endpoints News. “That’s why in short order…we had partnered with…AstraZeneca and Johnson & Johnson to be able to hit the ground running in a sense. It was a very unique time, and I think we’ve responded pretty well to be able to meet those manufacturing timelines.”
In March, the company announced that it would amp up supplies of the J&J Covid-19 vaccine That deal scaled up a vial filling line to line up with J&J’s FDA approval. Right now, the plant in Italy is solely focused on churning out J&J and AstraZeneca Covid-19 vaccines, until a need for another biologic arises. Within Catalent, the company has kept its eyes peeled for what the next big demand will be. But with news changing every day, and the problems the Delta variant has caused, it’s not ruling anything out.
“We just need to be prepared for anyone of those scenarios,” Clark said.
The plant made headlines in March, when Italian police officers raided it amidst complaints that AstraZeneca had been stockpiling doses of its vaccine, which AstraZeneca later denied, saying that the process was “complex and time consuming.”
The expansion adds on to its European operations in Limoges, France, and Brussels, Belgium, and stateside in Madison, WI, and Bloomington, IN. The New Jersey CDMO just wrapped up an expansion at the Wisconsin plant to add its fourth and fifth manufacturing suites with new single-use bioreactors
Since the pandemic, there’s been a flurry of activity within CDMO industry, and Catalent’s been at the forefront of that. Last week, it announced a partnership with Austin, TX-based Curtana Pharmaceuticals to make CT-179, its drug therapy for brain cancers. It also joined the cannabidiol world with a partnership with JOS Pharmaceuticals to study an awake anesthsia using CBD to use in cataract surgeries.